Two Clues to Tell if an IgM/IgG Antibody Blood Test Kit For Coronavirus Testing Is Quality

Two Clues to Tell if an IgM/IgG Antibody Blood Test Kit For Coronavirus Testing Is Quality

The FDA fired a warning shot in this article published on April 7th addressing the proliferation of serology tests coming to the US market.

After explaining the value proposition of serology tests, Stephen M. Hahn, M.D. notes that several of the more than 70 firms offering these tests are guilty of promoting FDA approval when that is simply not the case.

To date, only the serology test by Cellex has been granted an EUA from the FDA to promote and sell their antibody tests with their "blessing". 

To understand what the FDA “thinks” about these tests and what they hope to achieve by granting this EUA,  read the extensive documentation the FDA requires from Cellex and all their distribution partners.

It’s about collecting data to build a more robust picture of the scope of SARS-CoV-2 infections. 

Check it out.

This does not mean there is not an urgent need for serology tests to help rapidly screen and identify people producing the IgM antibody which signals infection.

Just as we have reached a point in this war where old T-shirts are being pressed into service as face masks because: “It’s better than nothing”; being tested with a serology test is better than not testing at all.

With so many serology tests hitting the market, some in violation of FDA guidelines, are there any signs to look for that will identify which antibody tests are good and which are questionable?

Besides for trial and error testing, there are two things that should raise questions.

Any manufacturer who is seriously pursuing FDA approval will make it difficult for their tests to be bought for personal use.

If they include accessories like lancets and alcohol prep pads, they were planning on making it easy for "mom and dad" to test their kids.

Likewise, if the kits come with individual dropper bottles with measured doses of buffer for a single test, that too is telling.

The CE approved five-minute antibody tests from Stellar Scientific were designed with FDA guidelines in mind.

Each box of 100 tests is divided into four bottles of buffer and four packs of twenty-five tests. 

No accessories are included other than an explicit statement that the tests cannot be relied upon as the sole determination of infection; sticking to the precise language as spelled out by the FDA.

While the need for these antibody tests grows by the day, they will service our nation best when they are done by licensed professionals who will share results to inform decision makers of the best way forward.