As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own

Every day, elected officials at all levels of government call for a huge expansion of COVID-19 serology testing. But, as most clinical laboratory managers and pathologists know, it is a complex undertaking for a lab to select any serological test, validate it, then run it daily in support of patient care, and have confidence that the results are accurate and reproducible.

Clinical laboratories across the United States understand the volume of testing will be in the tens of millions—even hundreds of millions—of COVID-19 serology tests. That is an important financial opportunity because it gives clinical labs the opportunity to generate some cash flow to offset the 60% decline in daily routine specimens they have experienced since most states enacted shelter-in-place orders in early March.

But this big opportunity to serve physicians and patients with COVID-19 serology testing also comes with equally big risks. There are three major risks a COVID-19 serology testing program that clinical labs must successfully address, otherwise the consequences can be devastating.

Three Major Serology Testing Risks for Clinical Laboratories

Risk one comes during the time when medical laboratories shop for COVID-19 serology tests. As of this writing, about 20 such tests have an emergency use authorization (EUA) with the Food and Drug Administration (FDA) and more are expected to obtain an EUA. As is true with everything in life, not all of these tests will perform equally. The risk to the lab is that it purchases a COVID-19 assay that later proves to be unreliable, despite the lab’s rigorous validation process.

Risk two derives from the fact that new diagnostic methods are being incorporated into the serology tests that companies are submitting to the FDA for an EUA. Although the data submitted to the FDA may indicate acceptable performance to the federal agency, in actual clinical use many unexpected or unknown factors could be recognized which lower confidence that the new method utilized by this particular assay is producing accurate results. That risk would only be recognized downstream from validation and the lab would find itself dealing with unhappy physicians, patients, and employers (who were using the test to check the health of their employees).

Risk three is supply chain risk. Will the manufacturer of the COVID-19 serology test be capable of supplying all of its clinical lab customers with adequate supplies to meet each lab’s demand for this testing? New manufacturers have an unknown track record in their ability to supply their lab customers. But even the largest in vitro diagnostics (IVD) manufacturers may need to ration kits, reagents, and other consumables to the large number of medical laboratories they serve. This happened with the rapid molecular tests for COVID-19. Community laboratories capable of performing these tests could not obtain adequate supplies to serve their client physicians.

Millions Lost on Faulty COVID-19 Serology Test Kits

If there is a fourth major risk to clinical labs performing COVID-19 serology tests for physicians, patients, and employers (who are screening employees in their workplace) it is the negative publicity that can result if a lab’s choice of a COVID-19 serology test ends up generating inaccurate or unreliable test results.

This is a risk not to be ignored. Dark Daily has already written about the global headlines that resulted after both Spain and the United Kingdom spent tens of millions of dollars on COVID-19 serology kits produced by Chinese companies, only to find out that these tests failed to perform at acceptable levels of accuracy. (See, “Chinese Firm to Replace Clinical Laboratory Test Kits After Spanish Health Authorities Report Tests from China’s Shenzen Bioeasy Were Only 30% Accurate,” April 3, 2020.)

The most recent example is here in the United States. On March 27, Abbott Laboratories announced that the FDA had issued an EUA for its Abbott ID NOW platform and its point-of-care rapid molecular test for COVID-19 that could produce results in less than 15 minutes. This made national news and was hailed regularly during the daily White House COVID-19 Task Force briefings.

But then, last week, the ID NOW COVID-19 test was again in the national headlines. For example, CNN published a story on May 14 with the headline, “Abbott’s Fast COVID-19 Test May Miss Too Many Cases, NYU Study Finds,” in which CNN wrote that authors of a study published on bioRxiv titled, “Performance of Abbott ID NOW Rapid SARS-CoV-2 NAAT,” from NYU Langone Health and Grossman School of Medicine in New York City said “the Abbott test was so inaccurate that it was ‘unacceptable’ for use with their patients.” Concerns centered around the true rate of false negatives. Abbott has robustly defended its test and more studies will be forthcoming.

What is important with the examples of Spain, United Kingdom, and a major IVD manufacturer is that news outlets are ready to pounce on any evidence that COVID-19 tests are returning inaccurate or unreliable results. This is a source of risk which every clinical laboratory wants to avoid.

How Clinical Laboratories Can Minimize Risk When Buying COVID-19 Serology Tests

Recognizing that clinical laboratories have been left to their own devices when selecting which of the 20 or so COVID-19 serology tests with EUAs they should buy, validate, and offer to their clients, The Dark Report and its new COVID-19 STAT Intelligence Briefings will present a free webinar titled “Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests,” on Thursday, May 21 at 1 PM Eastern Daylight Time.

This webinar will be conducted by James O. Westgard, PhD, Founder of Westgard QC, and Sten Westgard, Director of Client Services and Technology for Westgard QC.

During their upcoming webinar, James Westgard, PhD (above), and Sten Westgard of Westgard QC will address how clinical laboratory leaders can evaluate different serology COVID-19 tests by: understanding the testing architecture and intended medical use of COVID-19 testing, taking inventory of lab resources; navigating EUA, LDT, and non-EUA regulatory approval; assessing the expected performance of test methods; understanding the critical performance characteristics for COVID-19 testing; and much more. (Photo copyright: Dark Daily.)

This is an exceptional opportunity to gain an inside perspective of how your lab can address the three major risks identified above when selecting a COVID-19 serology test for use in patient care. You’ll gain essential insights about how to assess the public data on tests with an EUA.

This webinar presentation will also discuss how your lab should view all of its COVID-19 testing as a single program. That’s because your lab may test the same patient with a rapid molecular test, then later do serology tests in the days after the patient may have cleared the infection.

Register now for this critical educational opportunity by clicking here or by entering this URL in your web browser (https://www.darkdaily.com/webinar/quality-issues-your-clinical-laboratory-should-know-before-you-buy-or-select-covid-19-serology-tests/).

—Michael McBride

Related Information:

Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests, featuring James Westgard, PhD

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes

FDA EUA: Abbott ID NOW COVID-19 Test

NYU Study: Performance of Abbott ID NOW Rapid SARS-CoV-2 NAAT

Abbott’s Fast Covid-19 Test May Miss Too Many Cases, NYU Study Finds

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse.

25th Annual Executive War College July 14-15, 2020 Hyatt Regency, New Orleans, LA

14th Annual Lab Quality Confab November 17-18, 2020