presentation of gonorrhea

Patient Care & Health Information
Diseases & Conditions

To determine whether you have gonorrhea, your healthcare professional will analyze a sample of cells. Samples can be collected with:

A urine test. This can help identify bacteria in your urethra.
A swab of the affected area. A swab of your throat, urethra, vagina or rectum can collect bacteria that can be identified in a lab.

Testing for other sexually transmitted infections

Your healthcare professional may recommend tests for other sexually transmitted infections. Gonorrhea increases your risk of these infections, particularly chlamydia, which often accompanies gonorrhea.

Testing for HIV also is recommended for anyone diagnosed with a sexually transmitted infection. Depending on your risk factors, tests for other sexually transmitted infections could be beneficial as well.

Gonorrhea treatment in adults

Adults with gonorrhea are treated with antibiotics. Due to emerging strains of drug-resistant Neisseria gonorrhoeae, the bacterium that causes gonorrhea, the Centers for Disease Control and Prevention recommends that uncomplicated gonorrhea be treated with the antibiotic ceftriaxone. This antibiotic is given as a shot, also called an injection.

After getting the antibiotic, you can still spread the infection to others for up to seven days. So avoid sexual activity for at least seven days.

Three months after treatment, the CDC also recommends getting tested for gonorrhea again. This is to make sure people haven't been reinfected with the bacteria, which can happen if sex partners aren't treated, or new sex partners have the bacteria.

Gonorrhea treatment for partners

Your sexual partner or partners from the last 60 days also need to be screened and treated, even if they have no symptoms. If you are treated for gonorrhea and your sexual partners aren't treated, you can become infected again through sexual contact. Make sure to wait until seven days after a partner is treated before having any sexual contact.

Gonorrhea treatment for babies

Babies who develop gonorrhea after being born to someone with the infection can be treated with antibiotics.

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Preparing for your appointment

You'll likely see your primary healthcare professional. Here's some information to help you get ready for your appointment.

What you can do

When you make the appointment, ask if there's anything you need to do in advance, such as restrict your diet.

Make a list of:

Your symptoms, if you have any, including those that may seem unrelated to the reason for which you scheduled the appointment, and when they began.
All medicine, vitamins or other supplements you take, including doses.
Questions to ask your healthcare professional.

For gonorrhea, questions to ask include:

What tests do I need?
Should I be tested for other sexually transmitted infections?
Should my partner be tested for gonorrhea?
How long should I wait before resuming sexual activity?
How can I prevent gonorrhea in the future?
What gonorrhea complications should I be alert for?
Are there brochures or other printed material that I can have? What websites do you recommend?
Will I need a follow-up visit?

Don't hesitate to ask other questions.

What to expect from your doctor

Questions your healthcare professional is likely to ask you include:

Have your symptoms been continuous or occasional?
How severe are your symptoms?
Have you been exposed to sexually transmitted infections?

What you can do in the meantime

Avoid sexual activity until you see your healthcare professional. Alert your sex partners that you're having symptoms so that they can arrange to see a member of their healthcare teams for testing.

Gonorrhea: CDC fact sheet (detailed version). Centers for Disease Control and Prevention. https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm. Accessed Sept. 21, 2023.
Ghanem KG. Clinical manifestations and diagnosis of Neisseria gonorrhoeae infection in adults and adolescents. https://www.uptodate.com/contents/search. Accessed Sept. 21, 2023.
Gonorrhea. Office on Women's Health. https://www.womenshealth.gov/a-z-topics/gonorrhea. Accessed Sept. 21, 2023.
Gonorrhea. Merck Manual Professional Version. https://www.merckmanuals.com/professional/infectious-diseases/sexually-transmitted-diseases-stds/gonorrhea. Accessed Sept. 21, 2023.
AskMayoExpert. Chlamydia, gonorrhea, and nongonococcal urethritis. Mayo Clinic; 2023.
Speer ME. Gonococcal infection in the newborn. https://www.uptodate.com/contents/search. Accessed Sept. 21, 2023.
Workowski KA, et al. Sexually transmitted infections treatment guidelines, 2021. Morbidity and Mortality Weekly Reports. 2021; doi:10.15585/mmwr.rr7004a1.

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Am Fam Physician. 2022;105(4):388-396

Related Letter to the Editor: Doxycycline Preferred for the Treatment of Chlamydia

Patient information: See related handouts on chlamydia , written by the authors of this article, and on gonorrhea , which has been adapted from a previously published AFP article.

Author disclosure: No relevant financial relationships.

Infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae are increasing in the United States. Because most infections are asymptomatic, screening is key to preventing complications such as pelvic inflammatory disease and infertility and decreasing community and vertical neonatal transmission. All sexually active people with a cervix who are younger than 25 years and older people with a cervix who have risk factors should be screened annually for chlamydial and gonococcal infections. Sexually active men who have sex with men should be screened at least annually. Physicians should obtain a sexual history free from assumptions about sex partners or practices. Acceptable specimen types for testing include vaginal, endocervical, rectal, pharyngeal, and urethral swabs, and first-stream urine samples. Uncomplicated gonococcal infection should be treated with a single 500-mg dose of intramuscular ceftriaxone in people weighing less than 331 lb (150 kg). Preferred chlamydia treatment is a seven-day course of doxycycline, 100 mg taken by mouth twice per day. All nonpregnant people should be tested for reinfection approximately three months after treatment or at the first visit in the 12 months after treatment. Pregnant patients diagnosed with chlamydia or gonorrhea should have a test of cure four weeks after treatment.

Chlamydia trachomatis and Neisseria gonorrhoeae are the most common sexually transmitted infections (STIs) in the United States and are required to be reported to state health departments. Between 2015 and 2019, reported chlamydial infections increased by 19%, and reported gonococcal infections increased by 53%. 1 These bacteria commonly infect the urogenital, anorectal, and pharyngeal sites but can become disseminated to affect multiple organ systems. Untreated infections may lead to pelvic inflammatory disease; scarring of fallopian tubes, which can increase the risk of ectopic pregnancy; infertility; easier transmission of new HIV infection; and vertical neonatal transmission. 2

Risk Factors

Young people 15 to 24 years of age account for 61% of all newly diagnosed STIs. 1 Racial and ethnic minorities, men who have sex with men (MSM), and transgender and gender diverse people are at higher risk of STIs. Inequitable access to health insurance and physicians, language barriers, and distrust of medical systems because of discrimination account for some of these disparities, independent of individual sexual behavior. 3 , 4 Other risk factors are reviewed in Table 1 . 2

Taking a thorough sexual history is important to identify overall risk of infection, as well as anatomic site-specific risk factors. Physicians should create supportive spaces where patients feel safe sharing information by using open-ended questions; avoiding assumptions regarding sexual preferences, practices, and gender/sex; and normalizing diverse sexual experiences. To obtain a complete sexual history, the five P’s (partners, practices, pregnancy attitudes, previous STIs, and protection from STIs) model can be used as outlined in Table 2 . 2 , 5

The U.S. Preventive Services Task Force (USPSTF) recommends behavioral counseling on condom use, communication strategies for safer sex, and problem solving with those at increased risk of STIs. 6 Adolescents and adults diagnosed with an STI in the past year, people reporting irregular condom use, and those with multiple partners or with partners belonging to a high-risk group are at increased risk. Physicians should emphasize barrier protection as the best way to prevent STIs. 2

The USPSTF and Centers for Disease Control and Prevention (CDC) recommend annual screening for chlamydial and gonococcal infections to prevent infertility and pelvic inflammatory disease in sexually active people 24 years and younger with a cervix and in older people with a cervix who have risk factors. 2 , 7 The CDC also recommends at least annual screening for MSM based on their risk factors. Screening should include the pharynx, urethra, and rectum based on reported anatomic sites of exposure. After discussion with the patient, it may be necessary to screen those sites even without reported exposure because of underreporting of sexual practices. 2 Table 3 summarizes screening recommendations for chlamydial and gonococcal infections. 2 , 8 There are significant gaps in research as it pertains to screening transgender and gender diverse patients. 9 The CDC recommends screening based on an individual’s current anatomy and sexual practices. 2

Screening for urogenital infections only and neglecting pharyngeal and rectal sites of exposure will miss a substantial proportion of chlamydial and gonococcal infections. 10 In one study of women who engaged in oral or anal sex with men, the prevalence of pharyngeal gonorrhea was 3.5%; rectal gonorrhea, 4.8%; and rectal chlamydia, 11.8%. 10 Pharyngeal and rectal screening may be offered to people with female anatomy based on sexual practices and shared decision-making. 2 Current evidence for screening extra-genital sites is strongest for MSM. Urine-only screening in an STI clinic misses 83% of infections among MSM. 11 They should be screened at each anatomic site of sexual exposure, regardless of condom use, at least annually. 2 Routine testing for chlamydial infections of the oropharynx is not recommended, but many laboratories will test for gonococcal and chlamydial infections simultaneously. 2 If oropharyngeal chlamydia is diagnosed, it should be treated to decrease the risk of transmission. 2

Presentation

Most chlamydial and gonococcal infections are asymptomatic. 8 Symptoms of infection are reviewed in Table 4 . 2 Because dysuria may be a symptom of chlamydial and gonococcal infections and causes leukocytes on urinalysis, women presenting with dysuria may be inaccurately diagnosed with a urinary tract infection if STI testing is not performed. 12 , 13 In women at risk for STIs or with a negative urine culture, physicians can consider STI testing in those presenting with dysuria. A pelvic examination is not required for diagnosis and may not improve the diagnosis of chlamydia and gonorrhea beyond history and diagnostic testing. 14 However, if pelvic inflammatory disease is suspected, a pelvic examination should be performed. The differential diagnosis of chlamydial and gonococcal infections is summarized in Table 5 . 2 , 15

Diagnostic Testing

The CDC recommends using nucleic acid amplification testing (NAAT) for the diagnosis of gonococcal or chlamydial infections because it is the most sensitive. 2 Specimens can be taken from a first-stream urine sample without urethral cleansing before collection. 2 Clinician- or patient-collected vaginal or endocervical swabs are also acceptable specimens. Self-collected vaginal swabs are as sensitive as clinician-collected swabs and are preferred by patients. 16 , 17 A recent meta-analysis showed that urine samples and vaginal and endocervical swabs have similar sensitivity. 17 For patients with male genitalia, a patient- or clinician-collected urethral swab may also be obtained, although a urine specimen is preferred. 2

In 2019, the U.S. Food and Drug Administration (FDA) approved the Aptima Combo 2 Assay and Xpert CT/NG, which use NAAT, for extragenital swabs of the throat and rectum. 18 The binx health io CT/NG assay, Visby Medical Sexual Health Test NAAT, and Cepheid Xpert CT/NG (not a waived test by the Clinical Laboratory Improvement Amendments) are point-of-care tests for the diagnosis of chlamydial and gonococcal infections. 19 Point-of-care testing provides same-day results, decreases loss to follow-up, and reduces overtreatment. 20 , 21

All people who test positive or report known exposure to C. trachomatis or N. gonorrhoeae should be treated. Patients and their partners should be advised to abstain from sex for seven days after completing a single-dose regimen or until the completion of a seven-day treatment course and resolution of symptoms. 2 Nonpregnant people should be tested for reinfection approximately three months after treatment or at the first visit in the 12 months after treatment. Follow-up care recommendations are reviewed in Table 6 . 2 , 22 , 23

Patients presenting clinically with nongonococcal urethritis can be treated empirically at the time of evaluation while diagnostic testing is pending. Cervicitis should be treated presumptively in those younger than 25 years or those at high risk of infection if NAAT is not available or follow-up is uncertain.

CHLAMYDIAL TREATMENT

Although spontaneous clearance of chlamydial infections is possible, people with positive test results should always be treated. 24 Because of increasing macrolide resistance, the recommended treatment for non-pregnant people is now doxycycline, 100 mg, twice per day for seven days. 2 Physicians may alternatively choose to treat patients with a single 1-g dose of azithromycin, especially when adherence to a multidose regimen may be a concern. 2 Treatment regimens are reviewed in Table 7 . 2 , 22 , 23

GONOCOCCAL TREATMENT

In 2018, more than one-half of cases of gonococcal infection were estimated to be resistant to at least one drug, leading the CDC to change treatment recommendations to higher doses of ceftriaxone 25 ( Table 8 2 , 15 , 25 ) . Azithromycin is no longer a recommended therapy for nonpregnant individuals because of an observed sevenfold increase in gonococcal resistance between 2013 and 2018. 25

UNRESOLVED SYMPTOMS

Most treatment failures are caused by reinfection from sex partners who have not received adequate treatment, rather than treatment failure from antimicrobial resistance. 2 If symptoms do not resolve or a test is persistently positive in a situation in which reinfection seems unlikely (i.e., the patient has reported no new sexual contact and is taking medication as prescribed), an infectious disease specialist and local health department should be consulted in case of possible antimicrobial resistance. 2

PARTNER EVALUATION AND EXPEDITED PARTNER THERAPY

If seeking care in person is not possible, expedited partner therapy is a strategy in which sex partners of a person diagnosed with a chlamydial or gonococcal infection within the past 60 days can be prescribed treatment without being seen by the physician. This strategy is supported by the American Academy of Family Physicians. 2 , 26 If the diagnosed person has not had a sex partner in the past 60 days, the most recent sex partner can be offered treatment. Sex partners with symptoms should be referred for evaluation and treatment. 2 Laws in 46 states permit expedited partner therapy. 27 Because recommended gonococcal treatment is based on intramuscular administration of medication, every effort should be made to see partners of infected patients in person for treatment and testing for other STIs. 28 If permissible by state law and the partner is highly unlikely to receive care, partners of those with gonococcal infections may be treated with a single dose of cefixime (Suprax), 800 mg orally, with the addition of 100 mg of oral doxycycline twice per day for seven days if chlamydial infection was not excluded. 28 Written instructions should be given to patients to convey to their partners how to take the medication, warnings about side effects and allergies, when to seek medical care, and STI education. 2 The best evidence for use of expedited partner therapy services is for male partners of women with gonococcal or chlamydial infections. 27 The risk of missing concomitant infections in MSM requires a more nuanced discussion, but these patients may be offered expedited partner therapy through shared decision-making. 28

LYMPHOGRANULOMA VENEREUM

Lymphogranuloma venereum is caused by a C. trachomatis serovar and can become invasive and cause colorectal fistulas and strictures. Treatment should be started presumptively at the initial visit to prevent complications if there is clinical suspicion for lymphogranuloma venereum. 2 Partners should be evaluated and treated empirically with a non–lymphogranuloma venereum chlamydial infection regimen. 2

Gonococcal and chlamydial infections in pregnancy are associated with increased risks, including preterm birth, premature rupture of membranes, stillbirth, low-birth-weight infants, and neonatal infection. 29 , 30 Pregnant patients should be screened as outlined in Table 3 . 2 , 8 Those at high risk of infection should be screened again in the third trimester. 2 Anyone diagnosed with a gonococcal or chlamydial infection during pregnancy should have a test of cure approximately four weeks after treatment, at three months after diagnosis, and in their third trimester. 2

NEONATAL INFECTIONS

The prevalence of perinatal gonococcal infections is 0.2 to 0.4 cases per 100,000 live births. 31 The USPSTF recommends universal prophylaxis with ocular erythromycin 0.5% ointment to prevent gonococcal ophthalmia neonatorum. The risk of infection without prophylaxis is 30% to 40%, and it can cause blindness as early as 24 hours after birth. 31 N. gonorrhoeae can also cause septic arthritis, meningitis, rhinitis, vaginitis, urethritis, pneumonia, and skin infections in neonates. 2 Asymptomatic newborns exposed to gonorrhea at birth from an untreated birthing parent should be swabbed for infection at the conjunctiva, oropharynx, vagina, and rectum and presumptively treated for gonorrhea. 2

Neonates are at high risk of contracting an infection if chlamydia is untreated in pregnancy. 2 , 32 Infants exposed during birth do not need to receive chlamydial-specific prophylactic antibiotics but should be monitored clinically for symptoms. 2 Ophthalmia neonatorum presents a few days to several weeks after birth with eyelid edema, discharge, and ocular congestion. 2 , 32 Chlamydial infections of the eye are not prevented by prophylactic erythromycin ointment. 32 Unlike trachoma, which is a chronic infection spread through close contact, clothes, and flies, ophthalmia neonatorum does not result in scarring and blindness. Diagnosis of ophthalmia neonatorum can be made by swabbing the conjunctiva for culture, direct fluorescence antibody testing, or NAAT. 2 The recommended treatment is oral erythromycin. 2 There should be close follow-up because a second course may be required. 2 C. trachomatis can also cause neonatal pneumonia. Infants present between two and 19 weeks of age with a staccato cough, tachypnea, rhinorrhea, and rales. 2 , 32 Exposed infants are at high risk; if they present with pneumonia, they should be treated empirically for chlamydial infection while awaiting test results from culture, direct fluorescence antibody testing (lower sensitivity), or NAAT (not FDA approved for the nasopharynx). 2 , 32

Any child diagnosed with gonococcal or chlamydial infections should be evaluated for sexual abuse. 2 , 32 Although perinatally transmitted chlamydial infections can be found in children up to three years of age, sexual abuse is the most common cause of infection in children. 2

MANAGEMENT DURING THE COVID-19 PANDEMIC

Disparities in STI testing have been more pronounced due to reallocation of resources for SARS-CoV-2 testing and decreased testing due to social distancing and stay-at-home orders. 3 , 19 However, telemedicine use has increased during the COVID-19 pandemic and is well-suited for STI screening because physical examination is not essential for diagnosis or treatment. 14 , 33 At-home C. trachomatis and N. gonorrhoeae self-testing kits are not FDA approved; however, multiple studies have found that when patients are instructed by a physician via telemedicine, self-collected swabs at home will diagnose cases similarly to office-collected samples, with increased volume of testing offsetting a slightly lower test sensitivity. 19 , 34 – 36 Physicians can safely incorporate home-based testing and treatment into telehealth practice.

This article updates previous articles on this topic by Mishori, et al. 23 ; Mayor, et al. 15 ; Miller 37 ; and Miller . 38

Data Sources: The U.S. Preventive Services Task Force, Cochrane Database of Systematic Reviews, Essential Evidence Plus, Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and American Academy of Family Physicians websites were reviewed for relevant publications. A PubMed search was conducted using the terms Neisseria gonorrhoeae , Chlamydia trachomatis , diagnosis, and treatment for the past 10 years including English language, meta-analysis, randomized controlled trials, reviews, and systematic reviews. Search dates: January 28, 2021; February 14, 2021; March 30, 2021; July 25, 2021; and November 27, 2021.

Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2019. U.S. Department of Health and Human Services; 2021. Accessed November 28, 2021. https://www.cdc.gov/std/statistics/2019/default.htm

Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187.

Lieberman JA, Cannon CA, Bourassa LA. Laboratory perspective on racial disparities in sexually transmitted infections. J Appl Lab Med. 2021;6(1):264-273.

Hamilton DT, Morris M. The racial disparities in STI in the U.S.: concurrency, STI prevalence, and heterogeneity in partner selection. Epidemics. 2015;11:56-61.

Savoy M, O’Gurek D, Brown-James A. Sexual health history: techniques and tips. Am Fam Physician. 2020;101(5):286-293. Accessed November 28, 2021. https://www.aafp.org/afp/2020/0301/p286.html

Krist AH, Davidson KW, Mangione CM, et al. Behavioral counseling interventions to prevent sexually transmitted infections: US Preventive Services Task Force recommendation statement. JAMA. 2020;324(7):674-681.
Cantor A, Dana T, Griffin JC, et al. Screening for chlamydial and gonococcal infections: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2021;326(10):957-966.

Farley TA, Cohen DA, Elkins W. Asymptomatic sexually transmitted diseases: the case for screening. Prev Med. 2003;36(4):502-509.

Van Gerwen OT, Jani A, Long DM, et al. Prevalence of sexually transmitted infections and human immunodeficiency virus in transgender persons: a systematic review. Transgend Health. 2020;5(2):90-103.
Bamberger DM, Graham G, Dennis L, et al. Extragenital gonorrhea and chlamydia among men and women according to type of sexual exposure. Sex Transm Dis. 2019;46(5):329-334.
Marcus JL, Bernstein KT, Kohn RP, et al. Infections missed by urethral-only screening for chlamydia or gonorrhea detection among men who have sex with men. Sex Transm Dis. 2011;38(10):922-924.
Tomas ME, Getman D, Donskey CJ, et al. Overdiagnosis of urinary tract infection and underdiagnosis of sexually transmitted infection in adult women presenting to an emergency department. J Clin Microbiol. 2015;53(8):2686-2692.
Shipman SB, Risinger CR, Evans CM, et al. High prevalence of sterile pyuria in the setting of sexually transmitted infection in women presenting to an emergency department. West J Emerg Med. 2018;19(2):282-286.
Farrukh S, Sivitz AB, Onogul B, et al. The additive value of pelvic examinations to history in predicting sexually transmitted infections for young female patients with suspected cervicitis or pelvic inflammatory disease. Ann Emerg Med. 2018;72(6):703-712.e1.

Mayor MT, Roett MA, Uduhiri KA. Diagnosis and management of gonococcal infections [published correction appears in Am Fam Physician . 2013;87(3):163]. Am Fam Physician. 2012;86(10):931-938. Accessed September 22, 2021. https://www.aafp.org/afp/2012/1115/p931.html

Lunny C, Taylor D, Hoang L, et al. Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: a systemic review and meta-analysis. PLoS One. 2015;10(7):e0132776.
Rönn MM, Mc Grath-Lone L, Davies B, et al. Evaluation of the performance of nucleic acid amplification tests (NAATs) in detection of chlamydia and gonorrhoea infection in vaginal specimens relative to patient infection status: a systematic review. BMJ Open. 2019;9(1):e022510.

U.S. Food and Drug Administration. FDA news release: FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea. May 23, 2019. Accessed March 10, 2021. https://www.fda.gov/news-events/press-announcements/fda-clears-first-diagnostic-tests-extragenital-testing-chlamydia-and-gonorrhea

Kersh EN, Shukla M, Raphael BH, et al. At-home specimen self-collection and self-testing for sexually transmitted infection screening demand accelerated by the COVID-19 pandemic: a review of laboratory implementation issues. J Clin Microbiol. 2021;59(11):e0264620.
Van Der Pol B, Taylor SN, Mena L, et al. Evaluation of the performance of a point-of-care test for chlamydia and gonorrhea. JAMA Netw Open. 2020;3(5):e204819.
Gaydos CA, Ako MC, Lewis M, et al. Use of a rapid diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae for women in the emergency department can improve clinical management: report of a randomized clinical trial. Ann Emerg Med. 2019;74(1):36-44.
Dombrowski JC, Wierzbicki MR, Newman LM, et al. Doxycycline versus azithromycin for the treatment of rectal chlamydia in men who have sex with men: a randomized controlled trial. Clin Infect Dis. 2021;73(5):824-831.

Mishori R, McClaskey EL, WinklerPrins VJ. Chlamydia trachomatis infections: screening, diagnosis, and management. Am Fam Physician. 2012;86(12):1127-1132. Accessed September 22, 2021. https://www.aafp.org/afp/2012/1215/p1127.html

Geisler WM, Lensing SY, Press CG, et al. Spontaneous resolution of genital Chlamydia trachomatis infection in women and protection from reinfection. J Infect Dis. 2013;207(12):1850-1856.
St Cyr S, Barbee L, Workowski KA, et al. Update to CDC’s treatment guidelines for gonococcal infection, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1911-1916.

American Academy of Family Physicians. Expedited partner therapy. Accessed August 1, 2021. https://www.aafp.org/about/policies/all/expedited-partner-therapy.html

Centers for Disease Control and Prevention. Expedited partner therapy. U.S. Department of Health and Human Services; 2021. Accessed November 27, 2021. https://www.cdc.gov/std/ept/default.htm

Centers for Disease Control and Prevention. Guidance on the use of expedited partner therapy in the treatment of gonorrhea. U.S. Department of Health and Human Services; 2021. Accessed November 27, 2021. https://www.cdc.gov/std/ept/gc-guidance.htm

He W, Jin Y, Zhu H, et al. Effect of Chlamydia trachomatis on adverse pregnancy outcomes: a meta-analysis. Arch Gynecol Obstet. 2020;302(3):553-567.
Vallely LM, Egli-Gany D, Wand H, et al. Adverse pregnancy and neonatal outcomes associated with Neisseria gonorrhoeae: systematic review and meta-analysis. Sex Transm Infect. 2021;97(2):104-111.
Curry SJ, Krist AH, Owens DK, et al. Ocular prophylaxis for gonococcal ophthalmia neonatorum: US Preventive Services Task Force reaffirmation recommendation statement. JAMA. 2019;321(4):394-398.

Baker CJ. Red Book: Atlas of Pediatric Infectious Diseases . 4th ed. American Academy of Pediatrics; 2020.

Car J, Koh GCH, Foong PS, et al. Video consultations in primary and specialist care during the COVID-19 pandemic and beyond. BMJ. 2020;371:m3945.
Fajardo-Bernal L, Aponte-Gonzalez J, Vigil P, et al. Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections. Cochrane Database Syst Rev. 2015;(9):CD011317.
Carnevale C, Richards P, Cohall R, et al. At-home testing for sexually transmitted infections during the COVID-19 pandemic. Sex Transm Dis. 2021;48(1):e11-e14.
Chow EPF, Bradshaw CS, Williamson DA, et al. Changing from clinician-collected to self-collected throat swabs for oropharyngeal gonorrhea and chlamydia screening among men who have sex with men. J Clin Microbiol. 2020;58(9):e01215-20.

Miller KE. Diagnosis and treatment of Neisseria gonorrhoeae infections. Am Fam Physician. 2006;73(10):1779-1784. Accessed September 22, 2021. https://www.aafp.org/afp/2006/0515/p1779.html

Miller KE. Diagnosis and treatment of Chlamydia trachomatis infection [published correction appears in Am Fam Physician . 2008;77(7) 920]. Am Fam Physician. 2006;73(8):1411-1416. Accessed September 22, 2021. https://www.aafp.org/afp/2006/0415/p1411.html

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More in AFP

Pathophysiology

Gonorrhoea is transmitted through unprotected vaginal/oral/anal sex and can also be vertically transmitted from mother to child.

Neisseria gonorrhoeae is a Gram-negative diplococcus that has a strong affinity for mucous membranes. The organism can infect the uterus, urethra, cervix, fallopian tubes, ovaries, testicles, rectum, throat and less commonly the eyes. Once adhered to the mucous membrane, it invades the host cell and causes acute inflammation. N. gonorrhoea also has surface proteins that bind to the receptors of immune cells thus preventing an immune response.

Risk Factors

The following are risk factors associated with gonorrhoea, most of which are common to other STIs:

Aged <25 years
Men who have sex with men
Living in high density urban areas
Previous gonorrhoea infection
Multiple sexual partners

Clinical Features

While gonorrhoea is often asymptomatic, as occurs in around 50% of female cases, symptoms can usually develop 2-5 days following infection:

Genital infection

Figure 1. Vaginal discharge in female gonorrhoea infection

Altered/increased vaginal discharge (commonly thin, watery, green or yellow)
Dyspareunia
Lower abdominal pain
Rarely – intermenstrual and/or post-coital bleeding
Mucopurulent endocervical discharge
Easily induced cervical bleeding
Pelvic tenderness

Often examination can be normal.

Mucopurulent/purulent urethral discharge
Epididymal tenderness

Rectal infection

Usually asymptomatic
Anal discharge
Anal pain/discomfort

Pharyngeal infection

Usually asymptomatic (>90%)

Differential Diagnoses

A full STI screen should be undertaken for a patient presenting with gonorrhoea due to the common presenting symptoms of various STIs.

In particular, it is often very difficult to clinically differentiate between gonorrhoea and chlamydia infection. These infections often co-exist and therefore empirical treatment for gonorrhoea has the aim of covering both the causative organisms.

Investigations

If someone has suspected gonorrhoea, they should be referred to a GUM clinic or other specialist sexual health service for specimens to be taken:

Endocervical/vaginal swab – NAAT
Endocervical/urethral swab – microscopy and culture
First pass urine – NAAT
Urethral/meatal swab – microscopy and culture
Swabs for NAAT + microscopy & culture can be obtained from the throat, rectum or eye if indicated.

These swabs should then be sent for microscopy , culture or nucleic acid amplification testing (NAAT) . NAATs are the standard investigation for chlamydia and these tests often provide dual testing for both chlamydia and gonorrhea.

While waiting for these laboratory results the patient should be treated with empirical antibiotics if their signs and symptoms are indicative of gonorrhoea.

Following diagnosis of gonorrhoea, a patient should be treated with a single dose of intramuscular ceftriaxone 1g.

Patients should be offered screening for other STIs, especially chlamydia, as co-infections are common. People should be encouraged to contact previous sexual partners to advise them to be screened and treated empirically for gonorrhoea.

Future safe sex should also be encouraged and patients should abstain from sex until both partners have completed treatment. To ensure antibiotics have successfully treated a patient, a test of cure is recommended during a follow up appointment.

For full details please refer to the BASHH UK guidelines for the management of gonorrhoea .

Complications

If gonorrhoea is left untreated in females, it can lead to pelvic inflammatory disease (PID) , which can result in chronic pain, infertility and ectopic pregnancy. In males, gonorrhoea can spread from the urethra to the testes causing epididymo-orchitis which is painful but rarely leads to infertility. It can also lead to prostatitis . Disseminated gonococcal infection (DGI) is uncommon but can lead to joint pain and skin lesions.

A patient should be admitted to hospital if:

Systemic symptoms are identified (e.g. malaise, joint pain, fever, rash) as this suggests disseminated gonorrhoea which can potentially develop into a life threatening infection such as gonococcal meningitis.
Females show signs of complicated or severe pelvic inflammatory disease.

Gonorrhoea in Pregnancy

Having gonorrhoea during pregnancy may be associated with complications such as perinatal mortality, spontaneous abortion, premature labour and early fetal membrane rupture.

Figure 2. Neonatal conjunctivitis may develop if born to an untreated woman with gonorrhoea.

Gonorrhoea can be vertically transmitted during delivery from an untreated mother and this can cause the neonate to have gonococcal conjunctivitis, where the neonate will experience eye pain, redness and discharge. Prophylactic antibiotics can prevent this and treatment during pregnancy is the same as for uncomplicated gonorrhoea. For the infected neonate, urgent referal and appropriate treatment is necessary to prevent long term damage and blindness.

Rarely - intermenstrual and/or post-coital bleeding

[start-clinical]

[end-clinical]

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Laboratory Corporation of America Holdings (NYSE:LH) Q1 2024 Earnings Call Transcript

Laboratory Corporation of America Holdings (NYSE: LH ) Q1 2024 Earnings Call Transcript April 25, 2024

Laboratory Corporation of America Holdings beats earnings expectations. Reported EPS is $3.68, expectations were $3.46. Laboratory Corporation of America Holdings isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter ( see the details here ).

Operator: Good day and thank you for standing by. Welcome to the Laboratory Corporation of America Holdings First Quarter 2024 Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Christin O’Donnell, Vice President, Investor Relations. Please go ahead.

Christin O’Donnell: Thank you, operator. Good morning, and welcome to Labcorp’s first quarter 2024 conference call. As detailed in today’s press release, there will be a replay of this conference call available via telephone and Internet. With me today are Adam Schechter, Chairman and Chief Executive Officer; and Glenn Eisenberg, Executive Vice President and Chief Financial Officer. This morning, in the Investor Relations section of our website at www . Labcorp.com, we posted both our press release and an Investor Relations presentation with additional information on our business operations, which include a reconciliation of the non-GAAP financial measures to the most comparable GAAP financial measures, both of which are discussed during today’s call.

Additionally, we are making forward-looking statements. These forward-looking statements include, but are not limited to, statements with respect to the estimated 2024 guidance and the related assumptions, the recently completed spin-off of Fortrea Holdings Inc., the impact of various factors on the company’s businesses, operating and financial results, cash flows and/or financial condition, including the COVID-19 pandemic and global economic and market conditions; future business strategies, expected savings, benefits and synergies from the LaunchPad initiatives and from other acquisitions and other strategic transactions and partnerships and opportunities for future growth. Each of the forward-looking statements is subject to change based upon various factors, many of which are beyond our control.

More information is included in our most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and in the company’s other filings with the SEC. We have no obligation to provide any updates to these forward-looking statements, even if our expectations change. Now, I’ll turn the call over to Adam Schechter.

Adam Schechter: All right. Thank you, Chris, and good morning, everyone. It's a pleasure to be here with you today. We look forward to sharing our first quarter 2024 results and progress on our strategy. But before I do that, I want to address the recent announcement that Labcorp was selected as the winning bidder for select assets of Invitae. This transaction will advance our strategy to launch and scale specialty testing in areas such as oncology rare diseases. These are strong assets in important disease areas and strategically with our focus on specialty testing. Invitae has strong science, a great NGS platform and strong talent. Upon completion of the transaction, Labcorp expects approximately $275 million to $300 million in annual revenue, with the vast majority in specialty areas, such as oncology and rare diseases.

The purchase price for the transaction is $239 million. We expect the transaction to be dilutive to adjusted earnings by approximately 2% to 3% in the first full year. We expect the transaction to be accretive in year two and to exceed our cost of capital in year three. Now I'll move to the quarter. Labcorp delivered strong top line performance in the first quarter driven by growth in both of our businesses, diagnostic laboratories and biopharma laboratory services. We continue to execute well on our strategic priorities through being a partner of choice for health systems and regional local laboratories through launching key new tests in important therapeutic areas and by harnessing science, technology and innovation to bring new tests services and capabilities to our customers around the world.

Let's turn now to our first quarter financial results. In the first quarter, revenue totaled $3.2 billion and adjusted earnings per share was $3.68. Enterprise revenue for the quarter increased 5% compared to first quarter of 2023, with diagnostics revenue up 4% and biopharma revenue up 8%. Biopharma's growth was driven by strength in central laboratories, partly offset by early development research laboratories. Enterprise-based business margins are up compared to the prior year. Higher margins in biopharma were partially offset by diagnostics margins. We expect margins in both businesses to be up for the full year. The overall strength in our business enabled us to narrow the range and raised the midpoint of our EPS full year guidance to $14.90 despite a negative impact from currency.

Glenn will provide more details on our results and 2024 outlook in just a moment. In the first quarter, Labcorp advanced key growth initiatives that support our strategy. We began 2024 with positive momentum, reinforcing our position as a partner of choice for health systems and regional local laboratories. We continue to be active on the acquisition front. We closed three transactions in March, including health system agreements with base state health in Massachusetts and Providence in California and a regional lab acquisition in California. In March, we also entered into an agreement to acquire select assets of BioReference health diagnostics business. This transaction will increase access to Labcorp's high-quality clinical laboratory services.

These new assets are focused on clinical diagnostics and reproductive women's health. Our business development pipeline remains strong. Building on the success of our acquisitions and strategic partnerships, we continue to incorporate the power of science, technology and innovation across the organization. This commitment is demonstrated by how we've expanded our test menu this quarter. We advanced our leadership in neurodegenerative disease with the launch of our pTau217 blood-based biomarker test that aids in the diagnosis of Alzheimer's disease and the monitoring of patients undergoing treatment with new therapies. It's also available to be used in clinical trials. In addition, earlier this month, we announced the launch of our GFAP blood biomarker test for the early detection of neurodegenerative diseases and neurological injuries.

Following the launch of our ATN Profile last fall, these two significant advances in the company's testing portfolio extend our leadership in a rapidly accelerating field of blood-based biomarkers for neurodegenerative diseases. We continue to accelerate our leadership in oncology. We launched Labcorp Plasma Detect, the first clinically validated whole genome sequencing MRD solution for early-stage colon cancer to identify patients at increased risk of reoccurrence after surgery or adjuvant chemotherapy. Labcorp Plasma Detect developed by our PGDx laboratory is a significant achievement that enhances our liquid biopsy portfolio and strengthens our position at the forefront of driving better patient outcomes in oncology. We introduced a weight loss management test portfolio in the quarter, a suite of tests that supports individuals and physicians with accessible convenient testing options to guide weight loss management decisions and treatment, including lifestyle modifications, GLP-1 medications or bariatric surgery.

Labcorp OnDemand introduced a magnesium test and a micronutrient test to measure key vitamin and mineral levels to support individual wellness. We also announced an STI test for Mgen. Mgen can be as widespread as chlamydia and gonorrhea. This test includes a reflex to identify resistance macrolides, a commonly used treatment addressing high antibiotic resistance and treatment failures associated with the infection. In April, we received emergency use authorization from the FDA for our Mpox PCR test, a home collection kit. The test is the first annual collection kit authorized by the FDA to aid in the diagnosis of infection with Mpox. Physicians can order for patients 18 years of age or older who are suspected of Mpox infection. In addition, we launched our electronic requisition digital capability to help biopharma customers and investigator sites, improve protocol compliance by reducing errors queries, holes and data revisions.

Earlier this month, we released our latest corporate responsibility report, which highlights the significant progress that we're making as we pursue our mission to improve health and to improve lives in a sustainable way. We invite you to take some time to review the report that can be found on our Investor Relations website. As part of our earnings release this morning, we also announced our intention to create a new holding company named Labcorp Holdings Inc. to more closely align with our brand and better position us as a global organization. I'd like to thank our team of more than 67,000 employees around the world. Their ongoing commitment has once again earned us recognition of Fortune's World's most Admired Companies list. We're extremely proud of this recognition.

In summary, we continue to make progress against our strategy and to achieving both near-term and longer-term goals. We remain focused on our position as leaders in science, technology and innovation and driving further value for our customers, our shareholders and our employees. With that, I'll turn the call over to Glenn.

Glenn Eisenberg: Thank you, Adam. I'm going to start my comments with a review of our first quarter results, followed by a discussion of our performance in each segment and conclude with an update on our full year guidance. For reference, we've also included additional business information that can be found in our supplemental deck on our Investor Relations website. Revenue for the quarter was $3.2 billion, an increase of 4.6% compared to last year primarily due to organic base business growth and the impact from acquisitions, partially offset by lower COVID testing. The base business grew 6.7% compared to the base business last year, while COVID testing revenue was down 70%. Organically, in constant currency, the base business grew 4.3%.

Operating income for the quarter was $321 million, 10.1% of revenue or 14.3% on an adjusted basis. During the quarter, we had $49 million of restructuring charges and special items, primarily related to acquisitions and LaunchPad initiatives. In addition, we had $22 million of expense for transition service agreements related to the spin Fortrea, with corresponding income recorded in other income. Excluding these items and amortization of $60 million, adjusted operating income in the quarter was $453 million or 14.3% of revenue compared to $448 million or 14.7% last year. The margin decline was due to lower COVID testing. Base business margins were up as the benefit demand and LaunchPad savings were partially offset by higher personnel costs.

Our LaunchPad continues to be on track to deliver $100 million to $125 million of savings this year, consistent with our long-term target. The adjusted tax rate for the quarter was 23% compared to 22.1% last year. The higher adjusted tax rate was primarily due to a stock-based compensation benefit in the prior year. We continue to expect the full year adjusted tax rate to be approximately 23%. Net earnings from continuing operations for the quarter were $228 million or $2.69 per diluted share. Adjusted EPS were $3.68 in the quarter, up 7% from last year. Operating cash flow from continuing operations was a use of $30 million in the quarter compared to $186 million generated a year ago. The reduction in cash flow was due to lower cash earnings, primarily related to deferred taxes and the timing of working capital requirements.

Capital expenditures totaled $134 million in the quarter or 4.2% of revenue. This compares to $78 million or 2.6% in the prior year, which was impacted by the then pending spin Fortrea. For the full year, we continue to expect capital expenditures to be approximately 3.5% of revenue. Free cash flow from continuing operations for the quarter was a use of $164 million. The first quarter is seasonally the company's lowest quarter for free cash flow. We continue to expect free cash flow for the full year to be between $1 billion to $1.15 billion. During the quarter, the company invested $259 million in acquisitions and paid out $62 million in dividends. At quarter end, we had $99 million in cash, while debt was $5.1 billion. Our leverage was 2.5 times gross debt to trailing 12 months adjusted EBITDA.

Now I'll review our segment performance, beginning with Diagnostics Laboratories. Revenue for the quarter was $2.5 billion, an increase of 4.1% compared to last year, with organic growth of 1.8% and acquisitions net of contributing 2.2%. The base business grew 6.8% compared to the base business last year, while COVID testing revenue was down 70%. Organically, in constant currency, the base business grew 4.4%. Total volume increased 3.4% compared to last year. Base business volume grew 4.9% compared to the base business last year as organic volume increased 2.7%, while acquisitions contributed 2.2%. Price/mix increased 0.6% versus last year due to an organic base business increase that's partially offset by lower COVID testing. Base business organic price/mix was up 1.7% compared to the base business last year.

Diagnostics adjusted operating income for the quarter was $418 million or 16.9% of revenue compared to $442 million or 18.5% last year. The decrease in adjusted operating income was due to a reduction in COVID testing, while base business income was up as the benefit of demand and LaunchPad savings were partially offset by higher personnel costs. The decrease in adjusted operating income margin was due to a reduction in COVID testing, the negative impact from weather and the mix impact from lab management agreements, which we expect to improve over time. Now I'll review the segment performance of biopharma laboratory services. Revenue for the quarter was $711 million, an increase of 7.5% compared to last year due to increase in organic revenue of 5.1% and foreign currency translation of 2.4%.

The revenue growth was driven by continued strength in Central Labs, which was up 13%, while early development was down 4% due to continued higher-than-normal cancellations and lower orders. While cancellations are higher than normal, we have seen a sequential improvement from last quarter. Biopharma adjusted operating income for the quarter was $100 million or 14.1% of revenue compared to $74 million or 11.1% last year. Adjusted operating income and margin increased due to organic growth and LaunchPad savings, partially offset by higher personnel costs. We ended the quarter with a backlog of $7.9 billion, and we expect approximately $2.5 billion of this backlog to convert into revenue over the next 12 months. The trailing 12 months book-to-bill was 1.00, which we expect to increase throughout the year.

Now I'll discuss our updated 2024 full year guidance, which assumes foreign exchange rates effective as of March 31, 2024, for the remainder of the year. The enterprise guidance also includes the impact from currently anticipated capital allocation, with free cash flow targeted for acquisitions, share repurchases and dividends. We expect enterprise revenue to grow 4.8% to 6.4% compared to 2023. Compared to prior guidance, this is a narrowing of the range with the same midpoint despite a 50 basis point headwind from currency. We continue to perform well in diagnostics and are narrowing the full year guidance range and increasing the midpoint. We expect diagnostics revenue to be up 4.8% to 6% compared to 2023. This is an increase at the midpoint from our prior guidance of 140 basis points, primarily due to stronger base business demand as well as acquisition revenue that is now forecasted in this segment, where it was previously only included in the enterprise guidance prior to the closing of the transactions.

We expect biopharma revenue to grow 3.7% to 5.7% compared to 2023. The decrease at the midpoint from our prior guidance of 180 basis points is due to currency. This guidance includes the year-over-year positive impact from foreign currency translation of 40 basis points versus 220 basis points in the prior guidance. An improvement in the outlook for Central Labs is expected to be offset by early development. We continue to expect margins in diagnostics and biopharma to be up in 2024 versus 2023, driven by top line growth and LaunchPad savings. Our guidance range for adjusted EPS is $14.45 to $15.35. We have narrowed the range and increased the midpoint of guidance by $0.05, driven by improvement in diagnostics, partially offset by the change in currency.

The free cash flow guidance range is $1 billion to $1.15 billion, unchanged from prior guidance. In summary, we expect to drive continued profitable growth and strong free cash flow generation that will be used for acquisitions that support our strategy and supplement our organic growth while also returning capital to shareholders through our share repurchase program and dividends. Operator, we will now take questions.

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Q&A Session

Operator: Thank you. [Operator Instructions]. And our first question comes from Jack Meehan of Nephron Research. Your line is open.

Jack Meehan: Good morning. So I wanted to focus on the Invitae deal here. Let's start with Adam. Can you talk about the strategic value of these assets why you're excited to acquire them out of bankruptcy? And how does the oncology business complement? What you're doing already internally?

Adam Schechter: Hi, Jack. So they're strong assets. And we've always said that oncology is one of our core therapeutic areas, and they have a very big hereditary oncology business, much bigger than the business that we have in that area. So it certainly augments what we're doing and it accelerates it in a fairly significant way. They also have quite a bit of rare disease work that they've done, and that augments our focus on specialty testing. They have a very good NGS platform. We have a platform, but we're going to look to see what we can use that they have and use what we have and get the best platform we can possibly get. They have very good talent. And I think we're able to do it at a reasonable deal. It's a company that people have looked at for years and years that their valuation you could never get past. But the science was always very good. Their capabilities were always very good. So strategic that feel fits very well for us.

Jack Meehan: Yes, that makes a ton of sense. And then a second one for Glenn. Can you just talk about the strategy to work down the dilution? Prior to the bankruptcy, I think Invitae was targeting a burn of over $200 million. Some of that's related to things you're not acquiring, but your target -- you laid out calls for maybe $30 million to $50 million burn was my math. Can you just talk about the confidence it won't be worse than that and then the action steps to get to accretion in year two?

Glenn Eisenberg: Yes. Hi, Jack. So again, as Adam commented, we're very excited about the acquisition. And frankly, going out of acquiring the select assets through bankruptcy from a purchase price, obviously, relative to other deals that we see of similar focus in our therapeutic areas is quite attractive. As we think about long-term value creation, you heard in the opening comments that we expect this to exceed our cost of capital in year three and have a very attractive overall return on our investment. But to your point, in the near term, it will be dilutive. This is a business that has a high cost structure. And from our perspective, like other acquisitions that we've done of similar ilk we'll be able to leverage the cost structure within Labcorp to leverage.

It's a business that has a very high gross margin, which is, again, very attractive to us. Obviously, we'll continue to instill launch pad disciplines that we have which will benefit them as well. But the big opportunity to improve their profitability is on the cost side. They spend a fair amount in R&D, which we would expect to continue. Obviously, the value of what we're acquiring. But from sales, marketing and especially general administrative costs, where we can leverage our infrastructure we'll be able to get it profitable, as Adam said, within the first year. So it's all about integration. We'll do it on a very disciplined and timely manner, but we expect it to ultimately be accretive in the second full year of our ownership

Jack Meehan: Sounds good. Thanks, guys.

Operator: Thank you. One moment for our next question. And our next question comes from Erin Wright of Morgan Stanley. Your line is open.

Glenn Eisenberg: Good morning, Erin.

Erin Wright: Good morning. Could we talk a little bit about what's embedded in guidance as it relates to the acquisition contribution versus organic growth and base business strength in the diagnostics segment? I just want to make sure kind of can you remind us what's embedded in the enterprise level guidance versus the segment level guidance as well. Thanks.

Glenn Eisenberg: Yes. Hi, Erin. When we talk about the three acquisitions that we announced in the quarter, that's adding obviously to the change in the guidance we did for diagnostics. So when you look at the change, just use the midpoint of our guidance, it improved 140 basis points, I assume roughly half of that is from those three acquisitions. And again, those were already incorporated in our enterprise guidance but not until the segment until the deals were closed. So half of it is due to the acquisitions, and then the other half of the growth is demand. The strength that we saw in the first quarter that we also expect to see continued through the year.

Erin Wright: Okay. That's helpful. And then switching to the biopharma segment, what are you expecting for the balance of the year at this point? What are you seeing in terms of RFP flow and cancellations? And how would you just characterize the underlying health, particularly across that early development business? Thanks.

Adam Schechter: Yes. So I'll start overall and then I'll answer early development specifically. So overall, BioPharm Laboratory Services grew 8% and Central Labs had very strong growth at 13%. Now realizing Central Labs had a relatively easy compare versus first quarter of last year. You probably remember in first quarter of last year, there were a lot of personnel issues at investigator sites. If you look at the growth, it's coming back slower than we anticipated, but it's being offset by the strength in our Central Lab business. If you look at RFP flow, for central lab, everything looks normal, everything looks really strong. That business is very healthy. If you look at early development, we still continue to have good RFP flow.

The win rates are good. The cancellations still remain higher than what we would expect. The first quarter was a bit better than fourth quarter of last year, but still higher than what we anticipate. So as we go through the rest of the year, we were able to maintain the revenue guidance for BLS if you just adjust only for foreign exchange where Central Labs is going to continue to outperform, and we expect it's going to take a bit longer for the early development business to fully come back.

Erin Wright: Thank you.

Operator: Thank you. One moment for our next question. And our next question comes from Patrick Donnelly of Citi. Your line is open.

Adam Schechter: Good morning, Patrick.

Patrick Donnelly: Hi. Good morning, guys. I want to pick up kind of right where you left off there on the biopharma piece. Can you just dive a little bit deeper into early development? Obviously, again, the book-to-bill softened a little bit there on the BLS side. There's a lot of focus on the early development piece. Can you just talk about the visibility on that front? And again, the expectations as we work our way through the year, maybe both on orders and the revenue side would be helpful.

Adam Schechter: Sure. So I'll start with the book-to-bill. So the book-to-bill was 1.0 that's lower than we would typically like. However, we've got insight to the book-to-bill for second quarter already and insight to the rest of the year. And I expect the book-to-bill to continue to grow starting next quarter throughout the rest of the year. The health of the book-to-bill still looks good across the business. It's an early development part of the book-to-bill, which frankly, is a little bit less relevant because early development, a lot of the studies start in the year and finish in the year. Typically with the book-to-bill, you look for things that go more than a year or over time. So as I look at the early development book to bill, it's not where we would like it at the moment, but the RFPs are good.

The win rate looks good. It's the cancellations that are driving the majority of the issues. But that can correct itself faster typically because the burn rate is so much quicker. As we go through the rest of the year, we expect that the early development business starting in the second half will begin to be stronger than the first half.

Glenn Eisenberg: Yes. The only thing I'd add too, Patrick, is when you put the size of the business in perspective, obviously, it's less than 10% of the company. But even within biopharma you have two-third of the segment, let's say, Central Lab. And that's really where the backlog, if you will, the book-to-bill is probably more applicable because the backlog that we have in Central Lab is effectively supporting most of the revenues over the next 12 months. So to your point on visibility with early development, we have less visibility because it's a much lower percentage of the backlog with that business and much shorter lead times. So it just puts in a little bit more volatility, if you will. But on a positive side, as we ultimately see the rebound in that business, we'll be able to get those revenues and bring them into revenues on a quicker basis than we could have within Central Labs.

Operator: Thank you. One moment for our next question. And our next question comes from Michael Cherny of Leerink Partners. Your line is open.

Glenn Eisenberg: Good morning, Michael.

Michael Cherny: Good morning and thank you so much for taking the question. Maybe just one quick clarification on Invitae. You talked about the financial impact in the first full year post close. Is there any financial impact currently embedded in the guidance?

Glenn Eisenberg: So Michael, this is Glenn. When you look at the guidance that we've given, and we always kind of say the midpoint of the range is what our expectation is, and then there's always going to be pluses and minuses, which is why we put a range. So at the midpoint of our guidance, the answer is Invitae is not in those numbers. But when you look at the guidance range, so relative to the revenues of Invitae or the potential dilution in the first year, that would be incorporated, if you will, sizing it within the range we've given. So I guess the answer is it's not in the explicit guidance, but it's captured within the range that we've provided. We're looking to close this and it will obviously depend when we do, but let's say it's in the third quarter.

Obviously, when we have our announcement of our quarterly call, we will update our guidance to reflect, obviously, a half a year left. But obviously, acquisitions that would have been completed as well which, again, we may see Invitae for that time frame.

Michael Cherny: Okay. That's helpful, Glenn. And then maybe just on price and rev per rec. Can you just give us a sense on how it tracked over the quarter relative to your expectations? And in terms of the base business guidance increase for the Diagnostic Laboratories business, how much of that is the difference between improvements in volume versus improvements in price?

Glenn Eisenberg: Yes. So overall, we normally talk about our growth weighted to volume versus price mix and ratio, if you will. Obviously, it was a little different during the quarter, but strength, frankly, on both volume and on price mix. The price/mix really is mix related. We would normally say unit price is relatively flat. But the improvement that we saw in the quarter from a mix standpoint was the live management agreements, was the -- our test per session. We continue to see favorable movement and we're seeing a higher percent of our growth coming from our esoteric business versus routine. So all those three kind of improved our mix. But clearly, the growth that we expect to see is driven off of demand, which is volume.

Michael Cherny: Got it. Thank you.

Operator: Thank you. One moment for our next question. And our next question comes from Ann Hynes of Mizuho Securities. Your line is open.

Adam Schechter: Good morning, Ann.

Ann Hynes: Good morning. Thank you. How are you? So I just want to talk about just the volume and obviously, the Diagnostics segment is very strong. And it's in line with what your largest period as reported. And I'm just trying to figure out like how much is driven by underlying demand, which is strong, but also how much is driven by maybe the national companies taking market share? And if you are taking market share, who are you taking it from?

Adam Schechter: Yes. So Ann I'll give you -- broadly speaking, and then maybe Glenn can add some details. But broadly speaking, if you look at the hospital deals that we're doing, there's a significant number of them that we had last year at the end of the quarter going into this year. And when you do those, those are, by definition, getting some market share. And then when you think about what's happening in the marketplace around those hospitals, you expect that you'll pick up some market share there as well. So I think a lot of it is that the market is strong. You're seeing a lot more people getting procedures and so forth. But in addition to that, I think there is some share gains that you're seeing because of what we're doing and the strength that we have in the hospital market sector.

Glenn Eisenberg: Yes. No, the only thing I'd add is just that we had a good quarter, and we took our full year outlook up to reflecting the stronger demand than we've been seeing. We also look back to pre-pandemic, and we're tracking well within the range that we would normally expect to be. So some of the year-over-year improvement arguably has driven a bit about and not fully recovered year -- the prior year. But to see that kind of growth, we feel very good about and expect that to continue.

Ann Hynes: All right. And then secondly, heading into the final LDT rules for the FDA, what is backlog looking? Like what are the key things we should look for that you won't change in the final role?

Adam Schechter: Yeah. So the first thing I'd say is that the Labcorp was supportive of the Valid Act, which we thought was the right way to provide oversight of the FDA of LDTs. It was legislation that was fit for purpose for our industry. We're not supportive of the current rule, although we haven't seen the final rule. We still have to see that in a whole judgment until we see exactly what's in there. But I worry about most -- and we have great quality organization. We have terrific scientists, and we do so much research and need to -- it in the marketplace. What I worry about is speed to market of LDTs. And patients that need these LDTs, they're typically smaller groups of patients. Other people aren't necessarily developing tests for them. And they need to test as quickly as possible. So the real question to me is going to be how fast the FDA will be able to review the new LVPs and get them into the marketplace.

Ann Hynes: Great. Thanks.

Operator: Thank you. One moment for our next question. Our next question comes from Elizabeth Anderson of Evercore ISI. Your line is open.

Elizabeth Anderson: Hi, guys. Good morning. Thanks so much for the question. I was wondering if you could comment on the pacing of the lab management deal integration. Anything to pick up on proceeding as sort of as you guys thought any learnings you would say in terms of others as you continue on that path?

Adam Schechter: Yes. So we've gotten quite good at being able to efficiently and effectively run the lab management agreements that we have. When you do 100 hospitals with 1 organization quickly, you become an expert pretty fast. So what I would say is we take our time because the most important thing is to ensure that there's no patient disruption. The second thing is to make sure that the physicians are very satisfied with the way in which they can order and the speed once they get their results. And then over time, we find ways to use our size, our scale and our ability to synergize to reduce cost. And we've learned that the most important thing is to do it really well. And although the margins never get to our average margins, they start off low and they increase over time.

I think you've seen with the announcement of several deals closing in the first quarter, multiple deals closing at the end of last year. There's a slight impact on our margin in the beginning. But over time, the margin is going to improve. And that's why we believe our Diagnostics margin will increase when you look at the totality of 2024 versus 2023.

Elizabeth Anderson: Got it. That's helpful. Anything you can comment to in the early development business about sort of non NHP growth? Because I just wanted to like sort that out in terms of the impact on the revenues in the quarter.

Adam Schechter: Yes. So what I would say is that there's no longer a supply issue with NHP. The only thing that we're seeing with any fees is a bit of a revenue drag because the cost of NHPs when there was a supply issue were much higher. We were charging the higher price, but we weren't making a margin on that higher price. So now that the prices have come down, the actual revenue for those studies come down with the price. So you're seeing less revenue growth in that area, which I would say is probably a bit artificial because of the price of the NHPs coming down.

Elizabeth Anderson: Yes, that makes sense. I just wanted to sort of understand that versus the dynamics in the non-NHP portion of the business.

Adam Schechter: Yeah. I would say that -- in the non-NHP. You're seeing growth rates that would be a bit higher than the NHP. But again, that's more -- they're both less than what we have seen historically because of what's happening in the biotech world. We are beginning to see signs of recovery in the biotech world. So both of those parts of the business should recover over time.

Elizabeth Anderson: Got it. Thanks so much.

Operator: Thank you. One moment for our next question. And our next question comes from Kevin Caliendo of UBS. Your line is open.

Kevin Caliendo: [indiscernible]

Adam Schechter: Kevin, we can't hear you. You're breaking up pretty significantly.

Kevin Caliendo: I'm sorry, is it better?

Adam Schechter: No.

Kevin Caliendo: I'll try to ask you, but we wanted to talk a little bit about margin expectations in the DX segment, specifically around your expectation of labor trends and a margin in the GS business going forward, like in the first quarter as we jumping off…

Adam Schechter: Yes. Are you talking margins in CLS or Diagnostics? I couldn't tell.

Kevin Caliendo: Diagnostics, sorry.

Adam Schechter: Okay, in Diagnostics. What I would say is that if you look at the Diagnostics business, the business performed very well. We had basically 7% growth in the base business and volume was good at almost 5% and -- the margin was down versus prior year was driven by three things, it was driven by COVID. There was some impact from weather. And as I previously mentioned, there was some impact from the lab management agreements as we begin to roll those out in the fourth quarter of last year, so in the first quarter, we'll see the margins get better as we go through the year. Overall, we expect the diagnostic margins in '24 to be higher than the margins in '23.

Glenn Eisenberg: Yeah. The only thing I'd add too is, as Adam said, margins up even despite COVID and weather and lab management agreements for the full year margins to be up slightly but also to see that expected beginning in the second quarter where you'll see nice growth year-over-year. We'll have the normal seasonality. So when you look at the absolute margins, they'll fluctuate based on seasonality and but the year-over-year improvement, you'll see pick up nicely beginning in the second quarter that gives us the confidence that the margins will be up for the full year.

Operator: Thank you. One moment for our next question. Our next question comes from Andrew Brackmann of William Blair. Your line is open.

Adam Schechter: Good Morning, Andrew.

Andrew Brackmann: Morning. Thanks for taking the question. Maybe just to piggyback off some of those margin questions on the diagnostics front, but more specifically on the specialty diagnostics side of things, I guess, how should we be thinking about moving the moving pieces there moving forward? Obviously, you gave some color around invite, but just as that entire specialty business grows, how are you thinking about its impact on total segment margins here?

Adam Schechter: Yeah. So the first thing I would say is as we look at the businesses, they're both strong right now are routine testing as well as our specialty testing. We are seeing the specialty testing grow at a slightly accelerated rate versus the routine testing, but routine testing is still the vast majority of the business that we do. A big part of the reason that specialty testing is important is, number one, they're typically very serious diseases. Number two, when people get specialty testing, they get a lot of routine tests around those specialty tests as well. And then third of all, they typically or show how strong you are in science and innovation, and it's got a good overhang of the company because we are a scientifically based organization. So for those three reasons, you'll see specialty testing growing faster than routine testing, but routine tends to go with the specialty testing to some degree.

Andrew Brackmann: Okay. That's helpful and then I guess maybe a little bit unrelated, but as it relates to your Alzheimer's portfolio more specifically. Can you maybe just give us a sense of the current scale for that business today? And I guess, as you think in longer term here, just can you talk about the market opportunity that you see in that segment moving forward? Thank you.

Adam Schechter: Yes. What I would say right now. It's not a large part of our business. It's a very small part of our business, but it's an important part because there are new therapies that we believe will become available over time it's such an important disease and it's growing in the United States and around the world. So we want to have the broadest portfolio for physicians to use to help with the diagnosis and monitoring of Alzheimer's patients. But once again, many of those patients not only need these Alzheimer's test, but they use a lot of routine tests as they learn to diagnose these patients and monitor them over time. I would expect, over time, that market will grow, those tests will grow, but I think it will be to some degree, commensurate with how fast the overall prescription drug market grows because when diagnosed, the physicians also want to know what can I do about that? And what should I do about that?

Operator: Thank you. One moment for our next question. And our next question comes from Eric Coldwell of Baird. Please go ahead.

Adam Schechter: Good Morning, Eric.

Eric Coldwell: Good Morning. It's going to be an embarrassing question when you're afraid to ask it, but on the NHP and the pricing comments, I'm curious if you could give us any more detail on where your pricing is today. What it looks like going forward versus the recent past? One of your smaller competitors recently shared with the Street that it saw pricing down about 18% versus last quarter. I'm curious if you could frame it for you. And then I believe at the top of the market, NHP was about half of your early development work in total. I'm curious if you could give us a sense of what that mix looks like today.

Glenn Eisenberg: Yes. Eric, with regard to NHP pricing. We've not given what the step down in the pricing has been and obviously, it impacts the mix and where we get the primates from and where they're used in the studies. What we've commented is that it's been a nice reduction in the price from when we were capacity constrained and obviously, the prices were significantly higher and I think Adam referenced this earlier as well that from our perspective, while it impacts our revenues, it's really not impacting our profitability because most of the step down in the price of NHPs were pass-through. So the positive is it shows us a lower cost for our customers to get their studies done. So they're seeing the benefit of it without a negative impact from us overall. To your point, roughly half of the studies that we do are in HP based with the other half that are not, that mix really hasn't changed very much.

Eric Coldwell: Thanks, Glenn. I appreciate that, just maybe another macro question. The HLM deals come in at a lower margin, as you've always said, and you've done a flurry of them here recently and then the very big deal with Ascension. I know you're talking about improvements as you integrate and get those onboarded each over the next year each time. But could you give us an update on where Ascension is at this point, kind of the journey on that contract from the beginning to the present and how it's stacking up on a margin profile and possibly also a revenue profile versus your original expectations?

Adam Schechter: Yes, I'll let Glenn answer that question. Eric, before you guys, I think it's important to note that no two hospital deals are exactly the same, and it really is three pieces to them, right? There's a lab management part where you run a hospital's labs, there's the outreach business and there's the referral business. Ascension was kind of an outlier to most of the deals that we do because so much of it was the lab management part of the business, and that has by far the lowest margin that starts out low improves over time. Most of the deals that we do, they start out with a lower margin, but overall, with the kind of portfolio of the three types of business, they get to about our average margins over time. So that's the typical deal since it's a bit of an outlier, but maybe you can talk about Ascension.

Glenn Eisenberg: Yes. No, I think that's right. Especially given the size of the transaction overall. Let alone the percentage that was live management, but we normally, in Ascension, was a good example. Let's say, would be starting a mid-single-digit kind of margin, obviously, mixing us down that we've talked about and then we normally see the margin step up over the years. With that one, while we expect to see a step up, probably not as strong in just the second year of ownership as relative to others is we continue to share on a value basis, if you will, some of the synergies and the savings that we get, we're obviously passing on to that our large partner there and thereafter starting to see the step up. So positive direction, but we'll see more of an incremental improvement next year.

Adam Schechter: And the revenue for that looks very strong. It's slightly above what we had guided to originally.

Eric Coldwell: Okay. Thanks very much, guys.

Adam Schechter: Thank you.

Operator: Thank you. One moment for our next question. And our next question comes from Michael Ryskin of Bank of America. Your line is open.

Adam Schechter: Good morning, Michael.

John Kim: Hello. Good morning. This is John Kim on for Mike.

Adam Schechter: Good morning, John.

John Kim: So you've done a lot of deals. You have Invitae, BioReference and the three health system agreements that you closed in the first quarter and Glenn, you talked about how, given the range that in detail would be included in the top end of the guidance. So could you just update us on your thoughts on the deal funnel and your capital allocation priority? Are there any other larger deals, independent labs or health systems that are still coming our way?

Glenn Eisenberg: Yes. Thanks, so when you think about -- to your point, the transactions that we've done this year and as we commented, embedded in our guidance is the assumption. That we'll use our free cash flow for acquisitions, dividends and share repurchases. We have been -- this has been a good year for M&A. We've always talked about that we've had a strong pipeline of deals, and we're seeing them come to fruition this year. But between the three deals that we closed in the first quarter, the announcement of BioReference and Invite, you're looking from an M&A standpoint over $700 million of capital allocated to M&A this year. And then you put that with the dividends, you're getting closer to $1 billion. So, on the positive side.

We had a strong balance sheet. So another $100 million of call it, free cash flow is that will be used between M&A and share repurchases. But we're currently leveraged at around 2.5 times debt-to-trailing 12 months EBITDA, and we're at the low end of 2.5 times, and we give a targeted range of 2.5 to 3. So within that, call it, 0.5 point on a, call it, a $2 billion plus EBITDA basis. We have another $1 billion of capacity. So we'll still have a lot of financial flexibility to do share repurchases, to do tuck-in acquisitions that we feel are strategic, but we feel very good about the deals that we've announced this year. Obviously, we'll spend a lot of time integrating them into the company, but we have the -- obviously, the financial flexibility as well as still a good pipeline of potential opportunities on the deal front going forward.

John Kim: Got it. I appreciate that. And if I could ask one on the biopharma early development, so you talked about the cancellations coming down still a little high. But I wanted to ask, you previously talked about targeting perhaps medium-sized clients. Any -- has there been any shift or your win rates are good and last in the central lab, has there been any shift in that direction in terms of garnering attention or RFP from the medium-size clients?

Adam Schechter: Yes, so we're trying to improve our mix to more larger to medium-sized clients. It takes some time because many of those clients have master service agreements and you have to wait for us to expire or find ways to be part of those. But over time, I'm confident that we'll continue to shift the mix more towards the medium to larger size pharma.

John Kim: Got it. Appreciate that. Thank you.

Operator: Thank you. One moment for our next question. And our next question comes from Brian Tanquilut of Jefferies. Your line is open.

Adam Schechter: Good morning, Brian.

Brian Tanquilut: Good morning, I guess my question for you guys. In the past, as we thought about hospital lab acquisitions and outsourcing contracts, the distress in the space or the pressures in the hospitals was one of the driving factors. So as we're seeing broad utilization pickup in the hospital industry health seems to be improving. Adam, have the conversations changed? Or what does that pipeline look like today? And yeah, just curious what those dynamics are and how they're playing into future deals and agreements with hospitals?

Adam Schechter: Yes. No, it's a good question, Brian, and it's good news that the systems are doing better and that the hospitals are performing better. I think that's good for all of healthcare, frankly. So I'm pleased that they are beginning to rebound and do better. The interesting thing was before the issues with the health systems, a lot of the discussion was, can you do it and can you do it well? And should we take the risk that things aren't going to go well. Because we've done so many in so many large institutions, I don't think people have that question anymore. They realize that we are really good at this, that we can manage it better than they probably can by themselves that we'll have no physician interruption or patient interruption of note.

So therefore, they're willing to look and talk to us about continuing to do these deals. Now I think there was a sense of urgency that caused these deals to move quicker in the past. So I'm not quite sure the sense of urgency is there as much as it was before. But the number of discussions and the types of discussions we're having remain very good.

Brian Tanquilut: Awesome. Thank you.

Adam Schechter: Yes. Thank you.

Operator: Thank you. One moment for our next question. And our next question comes from Pito Chickering of Deutsche Bank. Your line is open.

Adam Schechter: Good morning, Pito.

Kieran Ryan: Hi there. You've got Kieran Ryan on for Pito. Thanks for taking the questions.

Kieran Ryan: I noticed you didn't touch on waiver when discussing the diagnostic margin drivers. I think one of your peers cited some modest improvement in the environment. So can you just give us an update on what you're seeing on labor as it relates to things like wage growth and turnover?

Adam Schechter: Yes, so I'll start with turnover, and I'll give a sense. Overall, across Labcorp, our turnover is better now than it was last year or the year before that. In our biopharma business, I'd say it's back to pre cover levels, maybe even a little bit better. So the turnover there has really improved. In our diagnostics, we see in certain areas, there's still a higher turnover than what we would have seen prior to the pandemic, particularly in frontline employees, where they have not only other choices in healthcare, but in other industries. But even there, we start to see less, turnover than what we've seen in the past. There's been a significant inflation of cost due to retaining employees in the past as we go forward. I think it will move back more towards the level of inflation of about 3% or so.

Kieran Ryan: Got it. Thanks, and then just a quick follow-up, the prior question was kind of talking about the strong demand that, hospitals and some providers you're seeing now. I was just wondering, does the top line guide in diagnostics at all contemplate a normalization in kind of broader utilization? Or are you just really not seeing anything outside of what you'd expect at this point? Thanks.

Adam Schechter: Yes. I would say that we're seeing what we would expect at this point is slightly higher, we give a range because there's a range of different things that may or may not occur. But overall, we think that the environment is healthy.

Glenn Eisenberg: Yes. When you look at the -- also, Pito, I guess, our implied guidance, so you're looking at a stronger top line growth than what we did in the first quarter with our guidance, but that's just really driven off of COVID becoming less of an issue. It was a bigger issue in the first quarter decline year-on-year, plus that's where we had the adverse impact from weather. So really when you adjust for that, as Adam's commented, the demand that we're seeing, which is came in a little bit stronger than we expected. We expect that to be similar demand going forward throughout the rest of the year.

Operator: Thank you. One moment for our next question. And our next question comes from Stephanie Davis of Barclays.

Adam Schechter: Good morning, Stephanie.

Stephanie Davis: Hi guys. Good morning. Thanks for taking my question.

Stephanie Davis: I feel bad about early development because, I said we're all focusing on this as a really small part of your business. But I have to ask because you did talk about some risk of potential share shifts when I saw you in March. So I think about the cut, is this more a function of higher for longer environment that could be impacting biotech funding? Is it something defensive early on, just in case maybe there are some potential share shifts? And how do we think about the underlying assumptions in terms of how they may have changed in use on cancellations and biotech funding in order to kind of enter new numbers.

Adam Schechter: Yes, so as I think about the early development business, I don't think that it's a share shifting. I think our share is remaining consistent within the parts of the market that we compete, we don't compete in all aspects of our -- we don't have a contract manufacturing organization, for example. But in the areas that we compete -- our win rates look good, our RFPs look good. So I believe that our market share is being maintained. I think we're seeing more that there's still a higher level of cancellations than what we've seen in the past. And in some instances, it's taking a bit longer for the companies to make their final decisions because they're still managing what I would say is a rather restricted budget even with the funding being better than it has been before.

So the good news is central laboratory, which is by far the largest part of that business remains very strong and we continue to expect it to be strong, and it's offsetting the weakness that we continue to see in ED that could go on for a bit longer. But even if it does, we feel that the strength that we're seeing in the largest part of the business offsets that.

Stephanie Davis: Super helpful. Thank you.

Adam Schechter: Sure.

Operator: Thank you. I'd now like to turn it back to Adam Schechter, for closing remarks.

Adam Schechter: I want to thank you all for joining us today. And hopefully, you can see we continue to advance our strategy and make significant progress. And we're going to continue our mission to improve health and improve lives around the world. Hope, everybody has a good day.

Operator: This concludes today's conference call. Thank you for participating. And you may now disconnect.

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v.195(24); 2023 Jun 19
PMC10281205

A practical approach to the diagnosis and management of chlamydia and gonorrhea

The incidence of chlamydia and gonorrhea, 2 common sexually transmitted infections, is increasing.
Annual asymptomatic screening for chlamydia and gonorrhea should be performed in all sexually active patients younger than 30 years, with more frequent screening for higher risk patients.
Nucleic acid amplification testing for chlamydia and gonorrhea should be performed in both asymptomatic and symptomatic patients at sites of sexual exposure, guided by a careful sexual history.
The treatment recommendations for chlamydia and gonorrhea are evolving and clinicians should follow local guidance.
Antimicrobial resistance in gonorrhea is increasing; optimal treatment should be guided by principles of antimicrobial stewardship.

The 2 most frequent reportable bacterial sexually transmitted infections (STIs) worldwide and in Canada are those caused by Chlamydia trachomatis and Neisseria gonorrhoeae . 1 , 2 Rates of both infections have been increasing over the last decade despite public health efforts aimed at prevention, testing and treatment. In 2019, 139 389 cases of chlamydia and 35 443 cases of gonorrhea were reported in Canada, an increase of 33.1% and 181.7%, respectively, since 2010. 2 These increases may reflect improved diagnostics, increased screening and contact tracing or a true increase in incidence. 2

Sexually transmitted infections have a substantial impact on affected individuals and communities. Chlamydia trachomatis and N. gonorrhoeae are commonly implicated pathogens in pelvic inflammatory disease and, if untreated, can lead to infertility. 3 Infection with a bacterial STI is associated with increased risk of HIV acquisition or transmission. 4 Perinatal transmission of C. trachomatis and N. gonorrhoeae can lead to ophthalmia neonatorum in infants, among other pathologies. 5 Treatment has become more challenging, given the increase in antimicrobial resistance in gonorrhea. 6

We summarize the management of chlamydia and gonorrhea in primary care as health care providers work collectively toward the goal of decreasing the frequency of these infections and reducing associated morbidity through appropriate treatment. We draw on evidence from clinical practice guidelines, systematic reviews and meta-analyses ( Box 1 ).

Box 1: Literature review

We conducted a targeted literature search of MEDLINE and Embase from inception to July 2022. Search terms included “ Chlamydia trachomatis ,” “ Neisseria gonorrhoeae ,” “sexually transmitted infection,” “STI,” “urethritis,” “cervicitis,” “pelvic inflammatory disease,” “proctitis,” “epididymitis,” “diagnosis,” “screening” and “treatment.” We limited the search to articles in English. Our targeted search focused on identifying clinical practice guidelines, systematic reviews and meta-analyses, although we did not place any formal restriction on article type. We selected relevant articles, and manually reviewed their references for additional articles.

Why is taking a good sexual history important?

Taking a sexual history is essential to comprehensive care in patients presenting with STI symptoms and in asymptomatic people to assess for STI risk, determine the need for screening, address concerns and provide sexual health education.

Patients have reported wanting their health care provider to inquire about sexual health, but many face considerable barriers to self-disclosure of their sexual history. 7 , 8 Stigma is often associated with STIs. Providers conducting a sexual history should do so in a nonjudgmental, patient-centred and trauma-informed manner. 9 Syndemics theory describes how disease interacts with social constructs, which can help conceptualize how a person’s unique social, cultural and health context influences how they access STI care. 10 Establishing the patient’s pronouns, sexual orientation and gender identity is necessary to create an environment of respect and trust. The components of a sexual history can be remembered by the 5 Ps: partners, practices, protection, past history and pregnancy ( Table 1 ). 11

Approach to taking a sexual history * 11

Note: STI = sexually transmitted infection.

What are common clinical presentations?

Most chlamydia and gonorrhea infections cause no symptoms. 12 If symptoms develop, the incubation period for gonorrhea is 2–7 days, compared with 2–6 weeks for chlamydia. 13 Chlamydia and gonorrhea may have genital or extragenital symptoms, which are generally reflective of the site of infection. The clinical presentations of chlamydia and gonorrhea overlap, and they are usually clinically indistinguishable.

Genital symptoms

Urethritis is the most common syndrome in patients with a penis who are symptomatic. It is characterized by dysuria, urethral pruritis and discharge. Most cases of infectious urethritis are caused by C. trachomatis and N. gonorrhoeae or both. However, in almost half of cases of nongonococcal urethritis, no specific organism is identified despite extensive microbiological investigation ( Box 2 ). 14

Box 2: Infectious differential diagnosis of common clinical presentations of sexually transmitted infections

Neisseria gonorrhoeae
Chlamydia trachomatis
Mycoplasma genitalium
Trichomonas vaginalis
Neisseria meningitidis
Hemophilus spp.
Herpes simplex virus
Trichomoniasis
Bacterial vaginosis
Chlamydia trachomatis (including lymphogranuloma venereum serovars)

Epididymitis

Enteric organisms (e.g., Escherichia coli )

Patients can develop acute epididymitis from chlamydia or gonorrhea, which is characterized by unilateral, posterior testicular pain and swelling, often accompanied by symptoms of urethritis. Among men younger than 35 years, C. trachomatis and N. gonorrhoeae are the most common causative organisms, but among older men and men who engage in insertive anal intercourse, causative agents can include enteric organisms like Escherichia coli . 15

Although cervicitis is often asymptomatic, symptoms may occur and include abnormal vaginal discharge or intermenstrual bleeding. 16 Findings on physical examination include purulent endocervical discharge or sustained endocervical bleeding. Most cases of cervicitis have no identified cause. In as many as 25% of cases, C. trachomatis or N. gonorrhoeae is identified. 17 In around 15% of female patients, pelvic inflammatory disease can develop, characterized by abdominal or pelvic pain, dyspareunia or abnormal uterine bleeding, with findings of cervical motion or adnexal tenderness on physical examination. 18 Patients may have infertility as a consequence of pelvic inflammatory disease. An uncommon complication of pelvic inflammatory disease is Fitz–Hugh–Curtis syndrome, characterized by right upper quadrant pain related to inflammation of the liver capsule. 17

Extragenital symptoms

Proctitis caused by chlamydia or gonorrhea may present with tenesmus, anorectal pain, bleeding and mucopurulent discharge. These infections typically occur in patients who engage in receptive anal sex, but can also be transmitted from the vagina to the anal canal. 19 Chlamydia trachomatis and N. gonorrhoeae are the most commonly identified pathogens in cases of infectious proctitis. 20

The lymphogranuloma venereum (LGV) serovars (L1, L2, L3) of C. trachomatis can cause invasive infections that preferentially affect lymphatic tissue. Lymphogranuloma venereum can present as small painless ulcers or painful hemorrhagic proctitis, with complications including anal fistulae and strictures. 21 In the last 2 decades, LGV has emerged as an important cause of proctitis among men who have sex with men (MSM) in North America and Europe. 22

Oropharyngeal infections with gonorrhea are commonly asymptomatic, although patients can present with sore throat, pharyngeal exudate or cervical lymphadenitis. 23 Chlamydia is not an important cause of pharyngitis. 24

Although uncommon, gonorrhea infection can cause bacteremia, leading to septic arthritis or disseminated gonococcal infection, with tenosynovitis, dermatitis or polyarthralgias. 23 Reactive arthritis — characterized by polyarthritis, conjunctivitis or uveitis, and urethritis or cervicitis — can occur after an infection with chlamydia or gonorrhea, although chlamydia is the more common inciting infection. 25

Who should be screened for infection?

Opportunistic screening is critical in identifying asymptomatic chlamydia and gonorrhea infections. The Canadian Task Force on Preventive Health Care recommends annual opportunistic screening for chlamydia and gonorrhea in all sexually active people younger than 30 years. 26 Although based on low-quality evidence, an opportunistic approach to screening is likely to increase the number of STIs diagnosed and destigmatize sexual health conversations.

More frequent screening should be offered to people at higher risk of acquiring STIs, although little evidence exists to guide the optimal frequency of screening. Among MSM, current guidance suggests, at minimum, anatomic site-based screening for chlamydia and gonorrhea annually. 13 , 24 More frequent screening (i.e., every 3–6 months) is recommended for at-risk people of any gender within groups who may be disproportionately affected by STIs, including those taking HIV pre-exposure prophylaxis (PrEP), those who have recently had an STI, those living with HIV or those with multiple sexual partners. 13 , 24 , 27 One cohort study of 557 MSM and transgender women taking HIV PrEP found that semiannual STI screening would have led to delayed diagnosis in more than 30% of patients with chlamydia or gonorrhea, compared with quarterly screening. 28 Pregnant patients should be screened at their first prenatal visit, with rescreening in the third trimester if they initially test positive for or are at ongoing risk of STIs. 13 , 24

Clinicians should determine appropriate anatomic sites for screening based on information from the sexual history, although they should consider screening extragenital sites (i.e., rectum and oropharynx), even in the absence of either reported symptoms or sexual exposures. Studies of people attending STI clinics have found that a considerable proportion of STIs are missed when STI testing is conducted only for patients with reported symptoms or on sites with known exposure, or when testing includes only urine. 29 , 30 Testing for gender-diverse patients will depend on their specific anatomy.

How should patients be tested?

In asymptomatic patients, approaches to sample collection for nucleic acid amplication testing (NAAT) for chlamydia and gonorrhea include a first-void urine (first 10–20 mL, any time of day, at least 1 hour since previous void) or vaginal swab; other options include a urethral or cervical swab ( Table 2 ). In patients with a vagina, a vaginal swab is preferred over first-void urine, as urine testing may detect 10% fewer infections. 31 Those with a neovagina or gender-affirming penile reconstruction should provide a urine sample for NAAT. Extragenital testing options include a pharyngeal or rectal swab for chlamydia and gonorrhea NAAT. In symptomatic patients, first-void urine and swabs of sites of reported symptoms should be collected for chlamydia and gonorrhea NAAT, and for gonorrhea culture and sensitivity testing. Patient-collected swabs are acceptable, as studies have shown equivalence between self-and clinician-collected oral, vaginal and rectal swabs for chlamydia and gonorrhea testing. 32 , 33 Self-collection may also improve uptake of STI screening. 13 , 24

Testing for chlamydia and gonorrhea

Note: NAAT = nucleic acid amplification test.

Clinicians should refer to their local microbiology laboratories for recommendations on collection and transport protocols in their region. First-void urine can be collected in a sterile urine container for chlamydia and gonorrhea NAAT. The swabs contained within chlamydia and gonorrhea NAAT kits can be used on the cervix, urethra, vagina, throat or rectum; swabs from these sites can also be sent for gonorrhea culture. Bacterial culture for chlamydia is not routinely performed in Canada. 13

Genotyping of LGV serovars can be requested if a patient presents with a syndrome consistent with LGV. 13 Some Canadian jurisdictions will automatically test all positive rectal chlamydia swabs for LGV serovars. However, it is important to indicate suspicion for LGV on laboratory requisitions, as automatic LGV testing is not universal, and nonrectal specimens (e.g., genital ulcers) are not automatically tested.

How should patients be treated?

Treatment of gonorrhea is challenging, as it readily develops antimicrobial resistance, and guidelines are not congruent in their recommendations. The Canadian STI guideline recommends dual therapy with ceftriaxone or cefixime, plus azithromycin or doxycycline ( Table 3 ). 13 The STI treatment guideline from the United States Centers for Disease Control and Prevention (CDC) increased the previously recommended ceftriaxone dose ( Table 3 ). 24 The CDC also recommended against dual therapy based on increasing antimicrobial resistance, and concern for impacts on the microbiome and selective pressure on other pathogens. 24 It is likely that this approach will be adopted by guidelines from other jurisdictions in the future. If monotherapy with ceftriaxone is used, an increased dose of ceftriaxone is recommended, compared with that used in dual therapy ( Table 3 ). 24 Currently, given varying recommendations, clinicians should follow local guidance, which will be based on resistance patterns in their area.

Treatment of chlamydia and gonorrhea

Note: CDC = Centers for Disease Control and Prevention, IM = intramuscularly, MSM = men who have sex with men, NAAT = nucleic acid amplification test.

The Canadian STI guideline recommends doxycycline or azithromycin as the first-line (preferred) treatment for chlamydia, 13 whereas the CDC recommends doxycycline as first-line treatment, with azithromycin as a second-line (alternate) regimen ( Table 3 ). 24 The preference for doxycycline is based on a systematic review and meta-analysis comparing treatment with azithromycin and doxycycline for chlamydia, which found that treatment failed more often with azithromycin, particularly among men with rectal chlamydia. 34 , 35 Thus, doxycycline is the preferred agent for treating rectal chlamydia. If adherence to therapy is a concern, single-dose azithromycin may be preferred. For pregnant patients, azithromycin is the first-line treatment. 13 For patients with suspected or confirmed LGV, treatment with doxycycline should be continued for 21 days. 13

Other treatment considerations

Given the potential complexity of cases and the evolving treatment landscape, providers should consult with an expert in STI management when necessary. All patients being treated for chlamydia or gonorrhea should be strongly advised to abstain from sexual activity for 7 days after treatment and until all partners have been treated. 13 Sexual partners from the previous 60 days should be tested and treated, or offered expedited partner treatment (i.e., clinicians can provide empiric treatment for the patient to give to their partner), which has been found to reduce the rates of recurrent or persistent infection. 36 Details around indications and timing of tests of cure are discussed in Table 3 . Tests of cure and repeat screening recommendations are often not followed, although they remain important for the appropriate care of the patient and to decrease transmission. 37

What about antimicrobial resistance?

Globally and in Canada, rates of antimicrobial resistance in N. gonorrhoeae are increasing, with decreasing susceptibility to cephalosporins and azithromycin. 6 , 38 In Canada, between 2012 and 2016, the proportion of multidrug resistant N. gonorrhoeae increased from 6.2% to 8.9%, with most isolates identified in Ontario and Quebec. 39 Actions that clinicians can take to combat antimicrobial resistance are to perform gonorrhea culture and sensitivity testing when possible to limit unnecessary antimicrobial use, and to forgo dual therapy for gonorrhea when chlamydia is excluded. Whether the widespread discontinuation of dual therapy for gonorrhea would negatively affect clinical outcomes or prevent antimicrobial resistance has not yet been established, however. Treatment can be delayed until test results are available in situations where reliable patient follow-up is likely. In cases of confirmed or suspected multidrug-resistant N. gonorrhoeae , clinicians should consider consulting an expert in the management of STIs.

Chlamydia and gonorrhea are the most common bacterial STIs in Canada, and their incidence is increasing. 2 Most infections are asymptomatic, which highlights the importance of routine screening for people who are sexually active. 26 Screening and diagnostic testing in symptomatic patients should be guided by a comprehensive sexual health history, which also provides an opportunity for patient education around sexual health. However, the optimal screening frequency in different populations remains unclear. With increasing rates of antimicrobial resistance, treatment should be guided by adherence to the principles of antimicrobial stewardship.

Acknowledgements

The authors gratefully acknowledge that they live and work on the ancestral, traditional and unceded territory of the Coast Salish peoples, including the Musqueam, Squamish and Tsleil-Waututh Nations.

Competing interests: Troy Grennan is Vice-chair of the Public Health Agency of Canada’s National Advisory Committee on Sexually Transmitted and Blood-Borne Infections and holds a Health Professional Investigator Award from Michael Smith Health Research BC. No other competing interests were declared.

This article has been peer reviewed.

Contributors: All of the authors contributed to the conception and design of the work. Clara Van Ommen drafted the manuscript. All of the authors revised it critically for important intellectual content, gave final approval of the version to be published and agreed to be accountable for all aspects of the work.

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Q&A Session

A practical approach to the diagnosis and management of chlamydia and gonorrhea

Box 1: Literature review

Why is taking a good sexual history important?

What are common clinical presentations?

Genital symptoms

Box 2: Infectious differential diagnosis of common clinical presentations of sexually transmitted infections

Extragenital symptoms

Who should be screened for infection?

How should patients be tested?

How should patients be treated?

Other treatment considerations

What about antimicrobial resistance?

Acknowledgements

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