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The Sports Medicine Research and Testing Laboratory (SMRTL) provides tests for the presence of performance-enhancing substances and common substances of abuse. SMRTL conducts comprehensive testing for anti-doping programs including international, national, and professional organizations, e.g. Olympic, Collegiate, Professional Sport Leagues, and Federal & State Departments.

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Deliver the highest quality results with an unquestioned chain of custody that supports the needs of the client throughout the testing lifecycle.

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Testing services and consultation tailored to the needs of your program. Multi-matrix sample collection methods and test kits that best-fit the dynamic nature of your organization. SMRTL is here to provide the expertise and support needed for our clients.

Please contact us to discover more about our organization, value chain partnerships, and to obtain a detailed proposal based on your requirements and objectives.

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Customized panel of testing fits the exact needs of our customers. Investigation into secondary substances using proven methods.

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Sports Medicine Research and Testing Laboratory in Utah Accredited by World Anti-Doping Agency

The Sports Medicine Research and Testing Laboratory (SMRTL), located at the University of Utah, has joined an elite group of laboratories worldwide accredited to test Olympic, Paralympic, and other amateur and professional athletes for performance-enhancing and other prohibited drugs.

SMRTL received accreditation November 1, 2006 from the World Anti-Doping Agency (WADA), making it one of two laboratories in the United States qualified to perform this complex and exacting analytical science. The other facility is at University of California, Los Angeles (UCLA). SMRTL was co-founded by the National Football League (NFL) and the United States Anti-Doping Agency (USADA), with significant financial and operational support from the University of Utah and the United States Olympic Committee (USOC).

The University of Utah was selected in December 2003 as the site for the development of the laboratory. Shortly thereafter, the United States Olympic Committee provided a $500,000 start-up grant to help create the lab.

The formal accreditation process is lengthy and thorough. It involved on-site inspections, compliance with technical requirements, and the successful analysis of samples that contained drugs and metabolites to determine the competency of the laboratory.

“There are only 34 WADA-accredited labs in the world,” said Dennis J. Crouch, SMRTL laboratory director and University of Utah research associate professor in the College of Pharmacy’s Department of Pharmacology and Toxicology. “It is an honor for us to be among the ranks of such an elite group and to be playing a role in ensuring fair competition as well as protecting the health of athletes.

The testing of U.S. Olympic, Paralympic, NFL and other athletes will now be distributed between SMRTL and UCLA, adding flexibility and capacity to the country’s anti-doping efforts.

“Earning accreditation as a World Anti-Doping Agency laboratory is a rigorous and exacting process,” said U.S. Anti-Doping Agency Senior Managing Director Dr. Larry D. Bowers.  “We congratulate Dennis Crouch, Doug Rollins and the staff at the Sports Medicine Research and Testing Laboratory in Salt Lake City for achieving the level of excellence required to merit this distinction. It is a great benefit to USADA to have the scientific expertise of two accredited laboratories at UCLA and the University of Utah.”

The NFL began using SMRTL in 2005 to screen players for performance-enhancing drugs. The NFL does not require WADA accreditation but demands equivalent expertise by the laboratories it uses in support of its drug control and prevention programs.

“The establishment of this laboratory is a major step forward in the NFL’s ability to monitor and detect the use of performance-enhancing drugs in its athletes,” said Dr. Bryan Finkle, forensic toxicologist to the NFL’s programs and President and Chairman of the Board of the new laboratory. “It enhances the commitment the league has made to address drug misuse and provides more opportunity for research critical to understanding the medical and analytical toxicology issues.”

“As we look for ways to intensify our efforts in the fight against doping in sport, having greater capacity to reliably analyze tests and conduct research is critical,” said U.S. Olympic Committee Director of Sports Medicine Ed Ryan. “We are proud to have contributed to the creation of this lab and believe that it will be an important resource in preserving the health and well-being of athletes and the integrity of sport.”

Drug detection is only part of SMRTL’s mission. The lab also will conduct research into substances that might be used in the future. In today’s environment, the use of substances that modify the body’s own biochemistry and mimic natural hormones makes detection a complex challenge. According to Crouch, the new laboratory will serve as an additional deterrent to underground sports medicine laboratories.

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Utah lab at center of MLB’s plan to return to play this summer

In this 2016 photo provided by the Sports Medicine Research and Testing Laboratory, President Dr. Daniel Eichner poses for a photo in Park City, Utah. Just 0.7% of Major League Baseball employees tested positive for antibodies to COVID-19, the illness caused by the new coronavirus. The University of Southern California and the Sports Medicine Research and Testing Laboratory in Salt Lake City also led the study. (Adam Finkle/Sports Medicine Research and Testing Laboratory via AP)

An anti-doping laboratory in Utah could play a major role in the return of Major League Baseball this season.

In laying out how the league plans to protect players and personnel against COVID-19, MLB Commissioner Rob Manfred said the league has paid to equip a lab with the ability to process thousands of tests each week. That facility is the Sports Medicine Research and Testing Laboratory in South Jordan.

Founded as the hub for athlete doping testing during the 2002 Olympics, SMRTL is a World Anti-Doping Agency certified lab. Since those Winter Games, it has continued to conduct testing within Olympics sports as well as through the PGA and UFC, among other sports organizations. Manfred, while speaking Thursday during a CNN Global Town Hall, said the lab had previously handled drug and substance abuse testing for Minor League players. It also processed an antibody test for a study run by Stanford University and the University of Southern California that MLB participated in.

CORONAVIRUS: We’re supporting #COVID19 research at an anti-doping lab. The PCC will fund #SMRTL to work with @USC , @Stanford , and boards of health to conduct 15,000 community COVID-19 tests. Here’s how we hope it helps: https://t.co/eLt2Mh8Aqn #academicchatter #cleansport pic.twitter.com/yv2fVPXWUD — The PCC - Funding Anti-Doping Science (@PCCantidoping) April 6, 2020

SMRTL may soon be at the center of a plan to test MLB players multiple times per week if the league’s proposal to play an abbreviated season is approved by the players union.

“We paid, made an investment, to convert them over to do the testing that we need in order to play,” Manfred said.

SMRTL was selected at least in part because of its guarantee of quick results.

“The lab in Utah has assured us of a 24-hour turnaround on all of our tests,” Manfred said. “So we feel comfortable by doing multiple tests a week and minimizing that turnaround time, we’re doing everything humanly possible to make sure the players are safe.”

Extensive testing is just one of a myriad of protocols the league has put in place as it eyes a return to play, albeit in empty stadiums, as early as July. Players and essential staff for the 30 teams would travel by chartered planes that will be thoroughly cleaned and sanitized between flights. High-fives, spitting and mound visits could potentially be banned, according to a report by the Wall Street Journal.

In addition, MLB personnel would be subject to daily temperature checks. If a player tests positive, he will be quarantined until he tests negative twice within a 24-hour period. Meanwhile, the league will use contact tracing to find others to whom the highly contagious coronavirus may have spread and will test them as well.

Players and staff will also be tested for antibodies, Manfred said, though less frequently.

COVID-19 testing supplies have notoriously been in short supply, but SMRTL may rely on a new form of testing when working with the MLB.

“All of our players would be tested multiple times a week” for coronavirus, MLB commissioner Rob Manfred says on the efforts to bring baseball back. “That testing would be supplemented less frequently by antibody testing as well.” #CNNTownHall https://t.co/zU95g1FwYr pic.twitter.com/J1MKyc5AJ0 — Anderson Cooper 360° (@AC360) May 15, 2020

Dr. Daniel Eichner, SMRTL’s president and director, spoke at a California State Athletic Commission virtual stakeholders meeting Monday. During that meeting, as first reported by ESPN, Eichner said his Utah lab is capable of analyzing results from polymerase chain reaction testing, which requires a deep nasal swab using a hard-to-find tip. He advocated, however, for use of a saliva test that shares technology with the at-home collection kit used by Ancestry.com . That test received Food and Drug Administration approval just last week and Eichner said it is just as accurate, “if not more,” than the nasal swab.

Eichner also emphasized the tests for MLB players would not take away from the resources SMRTL has dedicated to diagnosing the virus in the public health sector.

“We are by no means rediverting important resources away from front-line testing programs to do testing for sports,” Eichner said.

The lab will also continue to conduct anti-doping testing. Jeff Robbins, the president and CEO of the Utah Sports Commission, said SMRTL is expected to process tests of players in the PGA’s Korn Ferry Tour when it comes to Farmington’s Oakridge Country Club on June 25-28.

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SPORTS MEDICINE RESEARCH AND TESTING LABORATORY

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Biomechanical Research

Biomechanical research plays a critical role in ASMI’s mission in preventing sports-related injuries and improving current treatments.

In the James Andrews Biomechanics Lab, ASMI uses motion capture technology to identify movements and forces for athletes of various sports and levels. Through individual evaluations and large-scale research projects, ASMI enables athletes, coaches, trainers, and medical professionals improve sports performance and reduce the risk of injury. Furthermore, we continue to be on the forefront of sports biomechanics, developing and assessing emerging technologies such as markerless motion capture.

In the Musculoskeletal Research and Surgical Skills Lab , our biomechanists, surgeons, and fellows investigate clinically relevant questions about bone, tendon, and ligament pathologies, injuries, and surgical interventions. This is typically accomplished through mechanical testing of human cadaver bones, joints, and tissues in their native state, then in an injured state, and finally tested after an open or endoscopic surgical procedure. Results provide valuable insight into cutting-edge treatments in orthopaedic sports medicine. Lab capabilities include biaxial (axial/torsional) servohydraulic mechanical testing, six-degree-of-freedom electromagnetic motion analysis, and digital contact pressure measurement. Interested in learning more about participating in biomechanical research? Click here to learn about our student research internship.

SMTRL – Sports Medicine Research And Testing Laboratory

A 4-story office building for SMRTL has been designed after the company outgrew its incubator space at the University of Utah’s Research Park. Accredited by the World Anti-Doping Agency, the laboratory’s primary function is testing elite athletes for performance enhancing substances for high profile clients including the upcoming Olympics games. The exterior design includes a metal panel skin with wood siding incorporated to soften the entry from the street. Inside, the office and lab interiors are a clean, modern, and inviting workplace featuring pops of color and high transparency. Full height glass on all levels helps provide maximize views and daylight.

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Sports Medicine Research and Testing Laboratory in Utah Accredited by World Anti-Doping Agency

November 30, 2006 — The Sports Medicine Research and Testing Laboratory (SMRTL), located at the University of Utah, has joined an elite group of laboratories worldwide accredited to test Olympic, Paralympic, and other amateur and professional athletes for performance-enhancing and other prohibited drugs. SMRTL received accreditation November 1, 2006 from the World Anti-Doping Agency (WADA), making it one of two laboratories in the United States qualified to perform this complex and exacting analytical science. The other facility is at University of California, Los Angeles (UCLA). SMRTL was co-founded by the National Football League (NFL) and the United States Anti-Doping Agency (USADA), with significant financial and operational support from the University of Utah and the United States Olympic Committee (USOC). The University of Utah was selected in December 2003 as the site for the development of the laboratory. Shortly thereafter, the United States Olympic Committee provided a $500,000 start-up grant to help create the lab. The formal accreditation process is lengthy and thorough. It involved on-site inspections, compliance with technical requirements, and the successful analysis of samples that contained drugs and metabolites to determine the competency of the laboratory. “There are only 34 WADA-accredited labs in the world,” said Dennis J. Crouch, SMRTL laboratory director and University of Utah research associate professor in the College of Pharmacy’s Department of Pharmacology and Toxicology. “It is an honor for us to be among the ranks of such an elite group and to be playing a role in ensuring fair competition as well as protecting the health of athletes.” The testing of U.S. Olympic, Paralympic, NFL and other athletes will now be distributed between SMRTL and UCLA, adding flexibility and capacity to the country’s anti-doping efforts. “Earning accreditation as a World Anti-Doping Agency laboratory is a rigorous and exacting process,” said U.S. Anti-Doping Agency Senior Managing Director Dr. Larry D. Bowers. “We congratulate Dennis Crouch, Doug Rollins and the staff at the Sports Medicine Research and Testing Laboratory in Salt Lake City for achieving the level of excellence required to merit this distinction. It is a great benefit to USADA to have the scientific expertise of two accredited laboratories at UCLA and the University of Utah.” The NFL began using SMRTL in 2005 to screen players for performance-enhancing drugs. The NFL does not require WADA accreditation but demands equivalent expertise by the laboratories it uses in support of its drug control and prevention programs. “The establishment of this laboratory is a major step forward in the NFL’s ability to monitor and detect the use of performance-enhancing drugs in its athletes,” said Dr. Bryan Finkle, forensic toxicologist to the NFL’s programs and President and Chairman of the Board of the new laboratory. “It enhances the commitment the league has made to address drug misuse and provides more opportunity for research critical to understanding the medical and analytical toxicology issues.” “As we look for ways to intensify our efforts in the fight against doping in sport, having greater capacity to reliably analyze tests and conduct research is critical,” said U.S. Olympic Committee Director of Sports Medicine Ed Ryan. “We are proud to have contributed to the creation of this lab and believe that it will be an important resource in preserving the health and well-being of athletes and the integrity of sport.” Drug detection is only part of SMRTL’s mission. The lab also will conduct research into substances that might be used in the future. In today’s environment, the use of substances that modify the body’s own biochemistry and mimic natural hormones makes detection a complex challenge. According to Crouch, the new laboratory will serve as an additional deterrent to underground sports medicine laboratories.

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Accredited Laboratories

Contact Details

Prof. Dr. Emirhan Nemutlu

Turkish Doping Control Center (TDKM) , Ankara

Hacettepe University 06100 Sihhiye Ankara, Turkiye T: 90 312 305 2156 / 90 312 310 6776 F: 90 312 305 2062 E-mail: [email protected]

Dr. Supornchai Kongpatanakul

National Doping Control Centre - Analytical Sciences and National Doping Test Institute , Bangkok

Mahidol University – Bangkok, Thailand 2nd floor, Stang Mongkolsuk Building Faculty of Science Rama 6 Road, Rachathewee District, TH Bangkok 10400, Thailand T: (662) 354-7147-9 F: (662) 354-7150 E-mail: [email protected]

Dr. Rosa Ventura Alemany

Catalonian Antidoping Laboratory – Fundació Institut Hospital del Mar d’Investigacions Mèdiques (IMIM) , Barcelona

c/ Doctor Aiguader, 88 ES - 08003 Barcelona Spain T: (34.93) 316 0400 F: (34.93) 316 0410 E-mail:  [email protected]

Prof. Lisi (Leo) Zhang

Beijing Anti-Doping Laboratory Beijing Sport University (BSU) , Beijing

1, An Ding Road Chaoyang District – 100029 Beijing China T: (86.10) 8437 6289 E-mail:  [email protected]

Bloemfontein

*The World Anti-Doping Agency (WADA) has suspended the WADA accreditation of the Bloemfontein Laboratory due to nonconformities with the International Standard for Laboratories (ISL). The suspension is in effect for up to six (6) months as of 01 March 2024. The Bloemfontein Laboratory may continue to conduct the ABP Blood Sample analysis for Signatories in support of the Athlete Biological Passport hematological module.

Mr. Hanno du Preez

South African Doping Control Laboratory - Bloemfontein , Bloemfontein

Room F211 Pharmacology Building University of the Free State 205 Nelson Mandela Drive Park West, Bloemfontein, 9301 South Africa T: (27.51) 401 9511 E-mail: [email protected]

Dr. Cristina Stan

Romanian Doping Control Laboratory , Bucharest

B-dul Basarabia, nr. 37-39, București, sector 2, cod 022103 România T: +40 371 012 753 E-mail: [email protected] /  [email protected]

Prof. Mario Thevis Director

Institute of Biochemistry - German Sport University Cologne , Cologne

Am Sportpark Muengersdorf 6 D - 50933 Köln Germany T: (49.221) 498 24 920 F: (49.221) 497 32 36 E-mail: [email protected]

Dr. Prof. Alka Beotra

Doping Analysis Laboratory Director

Anti-Doping Lab Qatar , Doha

Building No 128 Sport City Road – Street No 665 Zone 54 PO Box 27775 Al Rayyan, Doha, Qatar T: (974) 44132915 F: (974) 44132997 E-mail: [email protected] / [email protected]

Prof. Dr. Peter Van Eenoo

DoCoLab Universiteit Gent-UGent , Ghent

Block B, 3rd floor Ottergemsesteenweg 460 BE-9000 Gent Belgium T: (32.9) 331 32 90 F: (32.9) 331 32 99 E-mail: [email protected]

Mr. Rodny Montes de Oca Porto

Antidoping Laboratory , Havana

Calle 100 esquina a Aldabo. Boyeros Ciudad de la Habana, Cuba CP 10800 T: (537) 643-76-49 / (537) 643-76-79 F: (537) 643 76-83 E-mail:  [email protected]  /  [email protected]

* Laboratory operations may temporarily be disrupted due to COVID-19. Communication with the Laboratory is recommended for further updates.

Dr. Tina Suominen

Helsinki Doping Control Laboratory Forensic Chemistry Unit, Finnish institute for health and welfare (THL) , Helsinki

P.O.Box 30 (Mannerheimintie 166, Fbuilding) 00271 Helsinki, Finland T: +358 (50) 307 3315 E-mail: [email protected]

Dr. Sven Voss

Institute of Doping Analysis and Sports Biochemistry (IDAS) – Dresden , Kreisha

Dresdner Strasse 12 DE - 01731 Kreischa b. Dresden Germany T: (49.35206) 2060 F: (49.35206) 20620 E-mail: [email protected]

Dr. Tiia Kuuranne

Laboratoire Suisse d’Analyse du Dopage Centre Hospitalier Universitaire Vaudois et Université de Lausanne , Lausanne

Chemin des Croisettes 22 1066 Epalinges Switzerland T: (41.21) 314 73 30 E-mail: [email protected]

Mr. João Ruivo

Laboratório de Análises de Dopagem - Instituto Nacional de Saúde Doutor Ricardo Jorge , Lisbon

Avenida Prof. Egas Moniz (Estádio Universitário) 1600-190 Lisboa – Portugal T 351 210 520 740 (office) T.351 210 540 360 (general) E-mail : [email protected]

Prof. Kim Wolff

Drug Control Centre King's College London , London

The Franklin-Wilkins Building 150 Stamford Street Fourth Floor, Corridor D GB - London SE1 9NH Great Britain T: (44.20) 7848 4848 F: (44.20) 7848 4980 E-mail: [email protected]

Los Angeles

Mr. Brian Ahrens

UCLA Olympic Analytical Laboratory , Los Angeles

2122 Granville Avenue Los Angeles, CA 90025 USA T: (310) 825-2635 F: (310) 206-9077 E-mail: [email protected]

Ms. Gloria Muñoz García

Madrid Anti-Doping Laboratory Laboratorio de Control del Dopaje del Instituto de Salud Carlos III , Madrid

Madrid Anti-Doping Laboratory  Laboratorio de Control del Dopaje  del Instituto de Salud Carlos III  Pintor El Greco, s/n 28040 Madrid Spain T: (+34) 91 822 40 97 E-mail:  [email protected]

Prof. Jean-François Naud

INRS Centre Armand-Frappier Santé Biotechnologie , Montreal

531, boulevard des Prairies Laval (Québec) H7V 1B7 Canada T: (450) 686-5442 F: (450) 686-5614 E-mail:  [email protected]

Dr. P.L. Sahu

National Dope Testing Laboratory (NDTL) , New Delhi

Government of India J.L.N. Stadium Complex, East Gate No. 10, Near MTNL Building, New Delhi – 110003, India T : (91.11) 24365530 / (91.11) 24368850 E-mail : [email protected]

Dr. Yvette Dehnes

Norwegian Doping Control Laboratory , Oslo

Aker Sykehus, B23 Trondheimsveien 235 0586 Oslo Norway T: (47) 22 89 49 14 E-mail: [email protected]

Dr. Magnus Ericsson

Laboratoire AntiDopage Français (LADF) , Paris

Université Paris-Saclay Bâtiment 409 Allée des Découvertes 91405 Orsay France T: (33) 6 17 80 18 18 E-mail: [email protected]  / [email protected]

Rio de Janeiro

Prof. Dr. Henrique Marcelo Gualberto Pereira

Brazilian Doping Control Laboratory – LBCD (Laboratório Brasileiro de Controle de Dopagem – LBCD – LADETEC / IQ - – UFRJ) , Rio de Janeiro

Avenida Horácio Macedo, 1281, Polo de Química, bloco C Ilha do Fundão Cidade Universitária - RJ 21941-598, Brazil T: 55 (21) 3938-3728 / 55 (21) 3938-3700 E-mail: [email protected] /  [email protected]

Prof. Francesco Botrè

Scientific Director

Laboratorio Antidoping FMSI , Roma

Federazione Medico Sportiva Italiana Largo Giulio Onesti 1 IT - 00197 Roma RM Italy T: (39.06) 87973500 F: (39.06) 807 89 71 E-mail: [email protected]

Salt Lake City

Dr. Daniel Eichner

The Sports Medicine Research and Testing Laboratory (SMRTL) , Salt Lake City

10644 South Jordan Gateway Salt Lake City, UT 84095 USA T: (801) 994-9454 / (866) 404-6561 F: (801) 994-9455 E-mail: [email protected]

Seibersdorf

Dr. Günter Gmeiner

Seibersdorf Labor GmbH Doping Control Laboratory , Seibersdorf

A - 2444 Seibersdorf Austria T: (43) 50550 3539 F: (43) 50550 3566 E-mail: [email protected]

Prof. Dr. Junghyun (John) Son

Doping Control Center Korea Institute of Science and Technology , Seoul

5 Hwarang-ro 14-gil, Seongbuk-gu Seoul 02792 Republic of Korea T: +82-2-958-5063 F: +82-2-958-6677 Mobile: +82-10-2683-7270 E-mail: [email protected]

Dr. Anton Pohanka

Doping Control Laboratory Karolinska University Hospital , Stockholm

C2-66 S-141 86 Stockholm Sweden T: (46.8) 58 58 10 75 E-mail: [email protected] /  [email protected]

Dr. Vanessa Agon

Australian Sports Drug Testing Laboratory (ASDTL) - Sydney , Sydney

National Measurement Institute Level 3, Australian Sports Drug Testing Laboratory 105 Delhi Road North Ryde NSW 2113 Australia T: (61.2) 94 49 01 11 F: (61.2) 94 49 02 95 E-mail: [email protected]

Dr. Masato Okano

Anti-Doping Laboratory LSI Medience Corporation , Tokyo

1-15-10 Shimura, Itabashi-ku JP-Tokyo 174-0056 Japan T: (81.3) 5994 2351 E-mail:  [email protected]

Dr. Dorota Kwiatkowska

Polish Anti-Doping Laboratory , Warsaw

Księcia Ziemowita 53 bud 4 03-885 Warsaw Poland T: + 48 22 290 29 05 F: + 48 22 290 29 04 E-mail: [email protected] / [email protected]

Related Resources

International Standard for Laboratories (ISL)

List of WADA-Accredited Laboratories

Office of the Vice President for Research

Lab week 2024: celebrating medical laboratory professionals.

April 14 - 20, 2024, is Medical Laboratory Professionals Week, an annual celebration to highlight and show appreciation for laboratory professionals, including those at the State Hygienic Laboratory (SHL) at the University of Iowa.

Lab Week is sponsored by the American Society for Clinical Laboratory Science and coordinated by 17 national clinical laboratory organizations.

“At the State Hygienic Laboratory, our teams have demonstrated again and again that we are prepared to skillfully respond to evolving emerging public health threats, adapting to meet the changing needs of laboratory medicine and the evolution of diagnostic testing,” said Michael Pentella, SHL director.

Established in 1904, the SHL works closely with local, state, and federal partners to fulfill its mission in the Iowa Code to investigate and evaluate any issues that are in the interest of environmental quality and public health in the state. The lab serves all of Iowa’s 99 counties through disease detection, environmental monitoring, and newborn and maternal screening. Today, the SHL also quickly responds to infectious disease threats, including mpox, SARS-CoV-2, whooping cough, and much more.

“Our teams are continually forward-thinking in terms of taking continuing education classes to prepare us for the future challenges of laboratory medicine,” said Pentella. “We are proud of our role to help ensure that Iowa communities are healthy places to live, work, and play.”

Stop COVID Cohort: An Observational Study of 3480 Patients Admitted to the Sechenov University Hospital Network in Moscow City for Suspected Coronavirus Disease 2019 (COVID-19) Infection

Collaborators.

• Sechenov StopCOVID Research Team : Anna Berbenyuk ,  Polina Bobkova ,  Semyon Bordyugov ,  Aleksandra Borisenko ,  Ekaterina Bugaiskaya ,  Olesya Druzhkova ,  Dmitry Eliseev ,  Yasmin El-Taravi ,  Natalia Gorbova ,  Elizaveta Gribaleva ,  Rina Grigoryan ,  Shabnam Ibragimova ,  Khadizhat Kabieva ,  Alena Khrapkova ,  Natalia Kogut ,  Karina Kovygina ,  Margaret Kvaratskheliya ,  Maria Lobova ,  Anna Lunicheva ,  Anastasia Maystrenko ,  Daria Nikolaeva ,  Anna Pavlenko ,  Olga Perekosova ,  Olga Romanova ,  Olga Sokova ,  Veronika Solovieva ,  Olga Spasskaya ,  Ekaterina Spiridonova ,  Olga Sukhodolskaya ,  Shakir Suleimanov ,  Nailya Urmantaeva ,  Olga Usalka ,  Margarita Zaikina ,  Anastasia Zorina ,  Nadezhda Khitrina

Affiliations

• 1 Department of Pediatrics and Pediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 2 Inflammation, Repair, and Development Section, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, United Kingdom.
• 3 Soloviev Research and Clinical Center for Neuropsychiatry, Moscow, Russia.
• 4 School of Physics, Astronomy, and Mathematics, University of Hertfordshire, Hatfield, United Kingdom.
• 5 Biobank, Institute for Regenerative Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 6 Institute for Regenerative Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 7 Chemistry Department, Lomonosov Moscow State University, Moscow, Russia.
• 8 Department of Polymers and Composites, N. N. Semenov Institute of Chemical Physics, Moscow, Russia.
• 9 Department of Clinical and Experimental Medicine, Section of Pediatrics, University of Pisa, Pisa, Italy.
• 10 Institute of Social Medicine and Health Systems Research, Faculty of Medicine, Otto von Guericke University Magdeburg, Magdeburg, Germany.
• 11 Institute for Urology and Reproductive Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 12 Department of Intensive Care, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 13 Clinic of Pulmonology, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 14 Department of Internal Medicine No. 1, Institute of Clinical Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 15 Department of Forensic Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 16 Department of Statistics, University of Oxford, Oxford, United Kingdom.
• 17 Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
• 18 Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
• 19 Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom.
• 20 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• PMID: 33035307
• PMCID: PMC7665333
• DOI: 10.1093/cid/ciaa1535

Background: The epidemiology, clinical course, and outcomes of patients with coronavirus disease 2019 (COVID-19) in the Russian population are unknown. Information on the differences between laboratory-confirmed and clinically diagnosed COVID-19 in real-life settings is lacking.

Methods: We extracted data from the medical records of adult patients who were consecutively admitted for suspected COVID-19 infection in Moscow between 8 April and 28 May 2020.

Results: Of the 4261 patients hospitalized for suspected COVID-19, outcomes were available for 3480 patients (median age, 56 years; interquartile range, 45-66). The most common comorbidities were hypertension, obesity, chronic cardiovascular disease, and diabetes. Half of the patients (n = 1728) had a positive reverse transcriptase-polymerase chain reaction (RT-PCR), while 1748 had a negative RT-PCR but had clinical symptoms and characteristic computed tomography signs suggestive of COVID-19. No significant differences in frequency of symptoms, laboratory test results, and risk factors for in-hospital mortality were found between those exclusively clinically diagnosed or with positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR. In a multivariable logistic regression model the following were associated with in-hospital mortality: older age (per 1-year increase; odds ratio, 1.05; 95% confidence interval, 1.03-1.06), male sex (1.71; 1.24-2.37), chronic kidney disease (2.99; 1.89-4.64), diabetes (2.1; 1.46-2.99), chronic cardiovascular disease (1.78; 1.24-2.57), and dementia (2.73; 1.34-5.47).

Conclusions: Age, male sex, and chronic comorbidities were risk factors for in-hospital mortality. The combination of clinical features was sufficient to diagnose COVID-19 infection, indicating that laboratory testing is not critical in real-life clinical practice.

Keywords: COVID-19; Russia; SARS-CoV-2; cohort; mortality risk factors.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].

Publication types

• Observational Study
• Research Support, Non-U.S. Gov't
• Hospitalization
• Middle Aged

Grants and funding

• 20-04-60063/Russian Foundation for Basic Research

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INFORMATION FOR

• Residents & Fellows
• Researchers

Intrahepatic Cholestasis of Pregnancy (ICP): Research Into Life-saving Diagnostics Receives Funding

While he was still in the womb, Judd William Gardner’s life was stolen by intrahepatic cholestasis of pregnancy (ICP), a liver disorder that can occur in the second or third trimester.

ICP can hinder an expectant mother’s liver function, leading to the buildup of bile—the fluid the liver generates to aid digestion. The condition is rare, impacting less than one percent of pregnant women in the United States, but its impact can be tragic. At high levels, the bile can become toxic to the unborn baby and increases the risk of fetal complications including stillbirth. ICP requires careful monitoring of the mother’s bile acid levels. If they rise too high, clinicians may need to induce labor to reduce the risk of complications.

Unfortunately, most hospitals are not equipped to test for ICP. They must send blood samples to outside laboratories, which can delay a diagnosis by precious days—and in some cases, can be too late.

Allison Gardner, Judd’s mother, already had an ICP diagnosis, but had been anxiously waiting for her latest bile acid results when she noticed her baby had stopped moving. She and her husband, Brandon, rushed to the hospital, where their worst fears were confirmed. Their unborn baby had died.

Gardner delivered Judd on October 27, 2018. Instead of celebrating their new role as parents, she and her husband laid him to rest just three days later. “I knew that there was something that needed to change, because there are so many unknowns with (ICP),” she says. “All of those unknowns are why we lost our baby.”

Gardner is now president of Judd’s Legacy , a non-profit with a mission to bring awareness to ICP, promote more rapid testing of the condition in hospitals, and fund research on treatment and diagnosis. In pursuit of this goal, the organization has awarded Yale School of Medicine’s Joe El-Khoury, PhD , associate professor of laboratory medicine, a $60,000 grant to fund research into improving diagnostic techniques for ICP. In 2019, El-Khoury’s lab adopted a test known as the Total Bile Acids, which can produce results in as little as an hour using standard automated chemistry equipment, but it is not widely used by other hospitals.

This grant will allow us to demonstrate the utility of this relatively newly implemented assay so that more clinicians can adopt it and more hospitals can recognize its value. For a small subset of patients, it may be the difference between life and death of their baby. Joe El-Khoury, PhD

“This grant will allow us to demonstrate the utility of this relatively newly implemented assay so that more clinicians can adopt it and more hospitals can recognize its value,” El-Khoury says. “For a small subset of patients, it may be the difference between life and death of their baby.”

Intrahepatic cholestasis of pregnancy is dangerous but overlooked

The most common symptom women with ICP experience is intense itching. But because other factors can also create itching during pregnancy, including hormonal changes and skin stretching, ICP can be overlooked by medical professionals. When Gardner began complaining of itching 32 weeks into her pregnancy, her Ob/Gyn in South Carolina shrugged it off and suggested she try the over-the-counter antihistamine Benadryl.

When clinicians diagnose ICP, the first-line treatment is ursodeoxycholic acid, or UDCA. The medication can lower concentrations of bile acid to safer levels. If this fails, providers may need to induce delivery of the baby.

Early detection of ICP is essential for protecting the baby. But to test for the condition, most clinicians send blood samples to laboratories outside of the hospital, that use mass spectrometry to measure the levels of specific bile acids. It typically takes three to five days to receive the test results.

In 2019, clinical providers in Yale’s Department of Obstetrics, Gynecology & Reproductive Sciences approached El-Khoury about the need for a faster way of diagnosing ICP in-house. He began exploring options beyond the standard mass spectrometry test when he came across the Total Bile Acids Assay Kit, an enzymatic assay previously approved by the Food and Drug Administration that can produce results in under an hour and with comparable results to mass spectrometry, considered the gold-standard in the field. “It was a newly released assay at the time, and to this day many labs don’t know about it or use it,” he says. “I can tell you that clinicians at Yale have been thrilled with the tests since we started using it.”

Non-profit awards YSM a research grant to study ICP diagnostics

Around the same time, Gardner met with Jenny Chambers, CEO of the United Kingdom-based organization ICP Support , to learn more about her advocacy efforts to encourage hospitals to implement more rapid ICP testing. Through her conversation, Gardner learned that Yale was one of the few hospitals in the United States that had recently adopted the Total Bile Acids.

Gardner decided to reach out to El-Khoury to share her story and learn more about the new test being used at Yale. Then, she began advocating for its implementation in hospitals in South Carolina, where she lived. At first, “this fell on a lot of different deaf ears,” she says. Then, she finally met Berry Allen Campbell, MD , maternal-fetal medicine specialist for Prisma Health and faculty member at the University of South Carolina School of Medicine, who helped advocate for the use of rapid testing within the hospital system.

Her next goal was to raise money to fund research, which could generate data supporting her cause. “Without research, the protocol of ICP treatment and diagnosis isn’t going to change,” she says. Through donations, sponsorships, and an annual 5K run, her organization raised $60,000 for the cause.

Gardner decided to get back in touch with El-Khoury to see what he could accomplish with these funds. “I outlined what we could do with the money to help push the field forward and raise awareness about the assay and how it could be used,” says El-Khoury. In February 2024, Judd’s Legacy officially awarded El-Khoury the funds.

New research to compare utility of new assay to standardized mass spectrometry testing

El-Khoury’s new grant will fund comprehensive studies that compare mass spectrometry testing and Total Bile Acids. He will also publish all of the existing validation data his laboratory produced when it first implemented the test in 2019. This will be important for providing hard evidence that the diagnostic results of the new assay are as reliable as the gold-standard testing.

The researchers are also interested in studying how the new assay impacts the length of hospital stays for patients. Hospitals may be keeping patients who are high-risk in the hospital until they receive back their test results, El-Khoury explains. But with the new test, clinicians can discharge patients immediately if their bile acid levels are not elevated. His team hopes to quantify and measure this impact.

Through this work, El-Khoury also hopes to spread the word about ICP and the importance of rapid testing. “The goal of all of this is to raise awareness about intrahepatic cholestasis of pregnancy and provide recommendations to labs,” he says. “We want them to know there is an alternative test out there that gives results within an hour and is just as useful as mass spectrometry.”

Because ICP is a rare condition, it is not only often overlooked by hospitals, but also by investors, El-Khoury says. Thus, funding is very limited. “Without this grant, research like this would not be possible.”

“I wanted my child to leave a legacy and make a difference here on Earth since he didn’t get the opportunity,” says Gardner. “We hope Judd’s passing brings about some good to save other babies and to prevent other families from going through the same heartache our family has experienced.”

Featured in this article

• Joe El-Khoury, PhD, DABCC, FACB Associate Professor of Laboratory Medicine; Director, Clinical Chemistry, Laboratory Medicine; Director, Clinical Chemistry Fellowship Program, Laboratory Medicine