If you’ve never interned in a hospital or were a graduate student whose funding was running out, you won’t appreciate the fervor of this activity.

 

But, at least 50 scientists, medical residents, and postdocs ran a marathon of testing.  (These folks were from UC San Francisco, UC Berkeley, Chan Zuckerberg Biohub [which partly funded this research], and the Innovative Genomics Institute.) Dr. Alan Marson (UCSF and CZBiohub) and Dr. Patrick Hsu (UC Berkeley) headed up the effort and relied on the process their colleagues, Drs. Jeffrey Whitman and Caryn Byrn, developed to examine the antibody tests for Chagas disease.    Dr. Tyler Miller (Mass General) independently analyzed three tests (using different procedures), with one of them also studied by the consortia.

Each of the researchers operated in shifts of 3, 4, or 5 hours, around the clock.  As one spots the test with a blood sample (from 80 folks known to have suffered COVID-19), another employs the chemical reagents, two more were independent readers, while the fifth recorded the results.  You might wonder why this was done- simply because the FDA has not performed its required task.

 

What was this marathon effort?  Determining if the 14 coronavirus antibody tests on the market actually pass muster.  Because without reliable data, we really can’t safely end our quarantine. 

 

Note that these test results have not undergone peer review, but with 50 folks checking, doublechecking, and triplechecking each other, we should be able to rely on these results.  Except.

 

They are terrible.  Only 3 of the 14 tests on the market yielded reliable (consistent) results.  None were flawless.  Only 1 test never reported a false positive and the other two didn’t achieve a 99% reliability against false positives.   The other problem?  The 3 best tests missed 10% of those infected.  (The best of the bunch? Sure Biotech, Wondfo Biotech, and a proprietary Elisa test.)

 

Which means reports that 1 in 5 New Yorkers have already had COVID-19 (the disease when infected with the SARS-CoV-2 virus) may be totally incorrect.  (Most of the rest of the US is showing a 3% incidence rate.)   These false positives may also be why the current thinking that those who have been infected with SARS-CoV-2 may not have developed permanent immunity is because many of those thought to have been infected may only be a false positive result.   These sad results also mean that we won’t know who is safe to allow out of quarantine.

 

These tests range from a yes/no antibody result (10 of the tests, called lateral flows) to Elisa (Enzyme-Linked Immunosorbent Assays, a test procedure that quantifies the amount of antibodies present).

 

 

Tests made by Sure Biotech and Wondfo Biotech, along with an in-house Elisa test, produced the fewest false positives. (One test, Bioperfectus, worked on 100% of the positives- but only if those were after 3 weeks of COVID-19 infection.  No other test exceeded 80% for those infected with less than 3 weeks duration.)

 

The problem seems to be related to two antibodies,  IgG and IgM.  IgM appears at the start of COVID-19, with IgG appearing later among those infected (and could be the antibody associated with permanent or semi-permanent immunity).

 

Another factor that may distort the results- the teams did not use the yes/no factor explicitly.  The consortia rated results on a scale of zero to 6, training the readers to recognize the gradations.  This sort of analysis actually improves the reported results. (In other words, only trained readers may be useful for these antibody-detection tests.)  The Mass General group, on the other hand,  eliminated the fainter bands (which are more likely to be false results); this change in ‘grading’  is why their results for the BioMedomics test increased from 87% (according to the consortia) to 99%.

 

For the full text of the COVID-19 Test Results :   https://www.dropbox.com/s/cd1628cau09288a/SARS-CoV-2_Serology_Manuscript.pdf?dl=0