As of early January, nearly 100 million specimens have been tested for SARS-CoV-2 using molecular assays in the United States alone, according to data reported to the Centers for Disease Control and Prevention (CDC)1. As the virus continues to mutate and the rate of hospitalizations continues to rise, it is essential that the medical community has ongoing access to reliable tests for the diagnosis of COVID-19 infections to support a strong response to the pandemic.
During the 2020 American Association for Clinical Chemistry (AACC) Annual Scientific Meeting, Thermo Fisher hosted an on-demand workshop on the clinical performance of the TaqPath COVID-19 Combo Kit, which was also one of the first tests granted Emergency Use Authorization (EUA) in the United States. As one of the first assays to target areas specific to the SARS-CoV-2 virus, Thermo Fisher Scientific’s Applied Biosystems TaqPath COVID-19 Combo Kit reduces the risk of detecting other coronaviruses and provides a highly reliable test for clinical and public health laboratories to quickly evaluate up to 94 patient specimens in under three hours.
In the workshop, Ninad Mehta, Ph.D., a clinical microbiology fellow at ARUP Laboratories, shared his team’s experience using the TaqPath COVID-19 Combo Kit in a comparative study evaluating the performance of the kit with two other EUA-authorized SARS-CoV-2 real-time PCR-based tests, the Roche cobas® SARS-CoV-2 Test and the Hologic Pather Fusion® SARS-CoV-2 assay. The study involved 300 nasal or nasopharyngeal swab specimens submitted for routine clinical testing to ARUP, which processes 10,000 to 15,000 samples daily through Thermo Fisher technology.
The study’s specimens were enrolled across a range of cycle threshold (Ct) values and retrospective testing was performed using the Roche and Hologic tests. ARUP investigated the discordant results between the three platforms and found both positive and negative percent agreement for identifying SARS-CoV-2 in patient samples.
Following Dr. Mehta’s analysis, Manoj Gandhi, M.D., Ph.D., senior director of medical affairs, Genetic Sciences, Thermo Fisher, presented on Thermo Fisher’s accelerated innovation to address COVID-19. Dr. Gandhi shared the company’s roadmap for rapidly expanding its COVID-19 testing portfolio to further support growing and evolving testing demands. For instance, Thermo Fisher recently received CE mark and EUA authorization for its multiplex kits to quickly detect SARS-CoV-2 and differentiate it from other respiratory viruses. As Dr. Gandhi presented, more than half of COVID-19 testing globally is performed using Thermo Fisher instruments.
The AACC on-demand workshop offers a closer look at Dr. Mehta’s performance data, workflow and implementation of the TaqPath COVID-19 Combo Kit for high complexity lab detection of SARS-CoV-2.
Watch the on-demand webinar and learn more about the details of Dr. Mehta’s study.
To learn more about Thermo Fisher Scientific’s COVID-19 Testing Solutions, please visit thermofisher.com/covid19.
[1] “ Key Updates for Week 52, ending December 26, 2020.” Centers for Disease Control and Prevention. December 26, 2020.
For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.