There’s good news coming for clinical laboratories as a tidal wave of orders for COVID-19 serology tests head their way while healthcare policymakers call upon tens of millions of Americans to be tested in the coming weeks and months for the COVID-19 antibodies.
This will be the single largest medical testing program ever undertaken in the US. The not so good news?
Soon, as many as 200 vendors will be selling their proprietary COVID-19 antibody tests, making it challenging for labs to determine reliability and validity.
As of today, more than 160 unique COVID-19 serology tests are available in the market. Yet only eight COVID-19 serology tests have an emergency use authorization (EUA) from the Food and Drug Administration (FDA).
To address these issues, COVID-19 STAT Intelligence Briefings has invited James O. Westgard, PhD, FACB and Sten Westgard, principals of Westgard QC, to conduct a timely webinar, entitled “Quality Issues Your Clinical Laboratory Should Know Before you buy or Select COVID-19 Serology Tests. The program will take place on Thursday, May 21, and participation is free as a public service to the clinical laboratory profession.
“Another reason the coming wave of COVID-19 serology tests can prove to be unwelcome news for labs is that a substantial number of these tests will be poor quality and expected to generate false positive and false negative results at an unacceptable rate,” says Robert L. Michel, President and Founder of The Dark Intelligence Group, and Editor of The Dark Report, who will moderate Thursday’s webinar. “That puts every clinical lab at risk of reporting inaccurate or false results, with dire consequences, and potential malpractice lawsuits.”
This is a high-stakes decision for your lab, Michel adds: “Pick the wrong COVID-19 serology test and your team will struggle with confidence that results are high quality, accurate, and reproducible. With the webinar, what is better than having the originator of the Westgard Rules guide you through the essential steps of evaluating different COVID-19 serology kits—and the associated data offered by the vendor—to weed out bad kits, and identify those with the highest likelihood of producing accurate, reproducible results?”
During this program, James Westgard and Sten Westgard will team up to address the following key points to help your lab team in its evaluation of different serology COVID-19 tests:
- Understand the testing architecture and intended medical use of COVID-19 testing
- Take Inventory of your laboratory resources
- Navigate the wild west of regulatory “approval”: EUA, LDT, non-EUA
- Assess the expected performance of test methods
- Understand the critical performance characteristics for COVID-19 testing
- Place it in Prevalence Context: How will it perform for your intended patients?
- Ascertain the reliability of the manufacturer
- Marshal resources for laboratory validation, verification and evaluation
To register for this free program, please click here. Can’t make the program live? COVID-19 STAT will also make it available on demand following the live program.
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