Is the flood of different COVID-19 serology tests bad news for clinical labs? Yes and no. Clinical laboratory managers and pathologists are well aware of the big undertaking it can be to select, validate, and implement a new COVID-19 serology test. The tests are brand new and abundant, and accuracy is an issue. But, a pro of these serology tests is the abundance of testing means an opportunity for financial gains, especially for labs with shelter-in-place orders since early March.
However, there are many risks when it comes to serology testing. One major risk is that the test simply doesn’t work. Tests can prove inaccurate or unreliable as time goes on. There are so many COVID-19 unknowns, and although these new methods are accepted by the FDA, real-life clinical use can have many unforeseen issues. On top of all that, acquiring materials is a big challenge – shipping times globally are unreliable. No one wants to squander valuable materials on a faulty test.
The negative publicity that could be attached to a faulty test is a real danger too. Many previous tests have since proven to be inaccurate which not only means bad PR, but wasted time, materials, and money.
Spain and the UK in spent millions of dollars on serology test kits from China which have since been failed tests. More recently, there has been a new test issued that could produce results of the COVID-19 results in less than 15 minutes. These tests have been used wildly among White House members. These tests have been since proven to be inaccurate and unacceptable to use. This causes unrest and distrust among the public, which is why serology testing can be risky.
There are ways for labs to ensure accurate serology test as discussed by James O. Westgard and Sten Westgard in a recent webinar. They address that by understanding the testing procedures, understanding the intended medical use of COVID-19 testing, taking inventory of the lab, and gaining EUA regulatory approval can greatly address the risks of COVID-19 serology testing.