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Assay Testing in Our CAP/CLIA Laboratory

Human Health In Vitro Diagnostics

Success in Respiratory Testing Prompts Expansion into Sexual Health and Virology Testing

Our College of American Pathologist (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified (CAP/CLIA) laboratory was utilized during the COVID-19 pandemic for the detection of SARS-CoV-2. In early 2020, the laboratory offered a single COVID-19 test – the Centers for Disease Control (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, which was also known as the “CDC test.” The CDC test was used to assess the clinical performance of new in vitro diagnostics (IVDs) for which manufacturers were seeking an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The availability of the CDC test at MRIGlobal set the foundation for expansion and our participation as a reference laboratory in support of new IVD tests. From June 2020 to September 2021, we performed more than 18,000 patient tests for the diagnosis of SARS-CoV-2.

Since then, MRIGlobal has continued to invest in the expansion of our CAP/CLIA laboratory through the establishment of the Clinical Diagnostics Testing and Evaluation (CDT&E) capability group and the procurement of state-of-the-art molecular diagnostics test systems. This expansion enabled the analysis of more than 19,000 reference tests in support of multiple clinical studies. Further, we have verified 17 IVD tests and validated one Laboratory Developed Test (LDT) for detection of respiratory viruses. MRIGlobal plans to maintain 15 reference tests for respiratory viruses and implement up to 15 new assays for infectious disease detection in fiscal year 2024.

During much of FY22 and FY23, our CAP/CLIA laboratory focused on the expansion of our reference testing capability, with our team having purchased and installed multiple state-of-the-art test systems. With these test systems and the associated test menu, our team offers a unique capability for sponsors to leverage during their clinical trials. 

Today, the laboratory is primarily utilized for clinical reference testing using EUA and 510(k) cleared tests. In addition, MRIGlobal performs patient testing for the detection of SARS-CoV-2 from patients suspected of infection with COVID-19, including MRIGlobal employees. MRIGlobal maintains CAP/CLIA status by adhering to many quality standards that include enrollment in the appropriate proficiency program, competency assessments for staff, and maintaining quality metrics throughout testing. By continuously meeting these requirements and standards, as of August 2023, the CAP/CLIA laboratory has verified and utilized 19 EUA or 510(k) cleared tests for either patient testing or clinical reference testing. 

As client needs arise, we also continue to verify new assays for EUA and 510(k) submissions to the FDA. In addition, availability of these test systems enables expansion of our capabilities beyond respiratory testing into sexual health and virology with greater efficiencies for our customers.



Contact MRIGlobal to further understand our work in infectious diseases. We offer a broad portfolio of infectious disease tests and capabilities across diagnostic disciplines, from screening and diagnosis to genotyping, therapy, and monitoring. Those seeking analysis of infectious disease tests can trust in our breadth of experience and knowledge – not just on the subject matter, but on FDA protocols as well. 

To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started. 


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