Tests that fail and those you should avoid, especially if conducting Employee COVID-19 Testing Under CALOSHA Directives
The news reports come fast and furious. Many of us read the reports, see it on media platforms, maybe even discuss the frightening implications, then move on to the latest drama, politics, Netflix.
They are the reports of a certain tests being found out as highly unreliable or inaccurate, or both.
The first? Rapid Antibody (not to be confused with Antigen) tests. These little finger-stick IGG/IGM tests were early to market, got FDA clearance, were cheap and everywhere.
Then you started hearing about what those of us in this industry already knew- that they are of the worst type of testing technology available. And that is true no matter what virus a finger-stick test is used for. Something you’d think would be obvious and also assume the FDA would be aware of.
Take a step back and think of it applying only common sense; a drop of blood on a $7 test plate will tell you if you have one or both of two distinct types of antibodies? Why would we ever go to the doctor to get lab-work done or ever do a full blood test if this amazing technology can be so accurate as to detect a new viral strain with just a single drop of blood?
Because that’s not possible and never was going to be possible using one of the lowest grade test types in the world- especially for something that is literally life and death.
So those using the rapid antibody tests moved on, and then the market became rife with non-EUA Rapid Antigen tests.
This is a bit trickier because, as we discussed in our last blog, an EUA is not at all indicative of test quality. An EUA indicates a test manufacturer provided their own compliant data and properly filed their paperwork.
We have used two non-EUA tests that performed exceptionally well, the GenBody and Healgen rapid antigen kits, both having an EUA "pending".
The issue is one of risk for claims against an employer for using a nonaccepted test. Also, OSHA rules and regulations are certainly met when a test with a full EUA is used. Whether a test with an EUA pending will pass muster with the OSHA rep that visits your business is questionable.
Lastly, there is hardly a cost difference between EUA tests and those with a pending EUA. Trying to save at most $5/test can prove a costly decision.
At the same time there was another rapid antigen test with tons of media fanfare; the Quidel Sofia. Great name. Garbage test. Why?
The Quidel Sofia represents an effort to fix what was never broken- they took what are analog tests by nature, and dressed it up with tech.
Rapid Antigen Tests have been around a long time and are known to be very reliable for things like detection of a respiratory infection. They are perfect as they are and that’s proven by our success with the AccessBio, GenBody and Healgen versions for detection of COVID-19. But they are analog- with no computer, no “device” needed to run the test. Just a cheap looking little test strip and some liquid (reagent), dropped onto that strip. Similar to a home pregnancy test.
What Quidel did is akin to taking a stick-shift car and putting some sort of mechanism on it to convert it to an automatic. And in doing so ruined what was already perfect.
The latest failure is Curative’s PCR test. Curative became a behemoth in the testing world with contracts to do all the testing for Los Angeles and several others like it. They were a darling with a young, telegenic CEO and enviable growth and advertising budgets.
Unfortunately, they chose to develop their own PCR test rather than use tried and true lab partners. That decision has resulted in what is likely to be hundreds of thousands of false test results- potentially millions.
Corporate clients in California, where an OSHA order mandates testing repeatedly until there are no positive results could never dig out because the false negatives meant infected employees were sent back to work alongside and infect other workers.
The takeaway is simple. Stay with what’s been tried and true. Work with companies that have history and reputation. And don’t believe the hype.
There is nothing new about the test types we have available in our industry. Antibody, PCR and Antigen tests have been around for decades. Thinking tech will provide a solution or create a better assay (testing method) is a fool’s errand. The people that bring these ideas to market and stir excitement are running that errand. Tune them out and talk to experts that are more turtle than hare.