COMPARATIVE REVIEW OF COVID-19 ANTIBODY TESTS:
The FDA’s first Emergency Use Authorizations (FDA EUA) was granted on 4/1/2020 to a 15 minute, P-O-C test from Cellex.
We have pooled our data with other offices around the country, and as of 5/5/2020, we had looked at a total of three FDA EUA P-O-C tests, all three lacking specificity, effectively rendering themselves useless for most of USA where prevalence is thought to be low (<10%).
The table below explains why our patients (and actually any patient) should refrain from any 15 minute P-O-C Antibody tests. It also helps explain why Optimal Men’s Center is using only laboratory assays from certain manufacturers.
We understand the data can be confusing. The take home message from this analysis is that even though no test has 100% accuracy, the table below, gives us some perspective that the chances are rather high or low when it comes to a person’s previous exposure to Covid-19.
For P-O-C tests, Cellex, Chembio and AutoBio all have obvious flaws. If you took one of these tests and it showed you it was Positive, now you think, “hey, I am going to see grandma next week.” But, it was wrong, and you caught Covid-19 (so you had NO protection/NO immunity), and then you showed no symptoms. You go visit grandma…hopefully, she does ok. We would not trust our life, our families lives’, or patients’ if we had better choices for testing.
So, the 3 most accurate tests that we use are all sent to a lab. As of this writing, first, by a wide margin, is ABBOTT Labs (used by LabCorp), followed by Roche. EUROIMMUN is the most common one used by Sonora Quest, for which we have control of who they use, but we would prefer Roche. But, they are not available in our area.
Figure #1: Practical Value Of All FDA EUA P-O-C Antibody tests in different US regions.
Why did we use 3 different prevalence scenarios:
[Note: TESTING FOR COVID-19 CURRENT INFECTION – We recently reviewed ScienceCell SARS-COV-2 test for current infection with Covid-19. It initially appeared to have some accuracy but now we are unable to evaluate its effectiveness. On April 23, 2020, the price was $250, but on May 12, 2020 shows the price of $480 on their website.
See https://www.sciencellonline.com/sars-cov-2-rt-qpcr-detection-kit.html for details.
Primerdesign Ltd. COVID-19 genesig Assay currently has a list price of $1507. Definitely some price gouging going on but this one is another possible test to verify if you currently are infected and is P-O-C. QuestDiagnostics SARS Coronavirus With CoV-2 RNA Test is a NasoPharyngeal Swab for current infection and priced at $250.
Good news on the Antibody front as Quest recently developed an IGG Antibody Test but as of this time, we have not received a firm price. Preliminary pricing appears to be $200-$250. Once again, unable to evaluate effectiveness as of yet.]
Figure #2: Details of NPV PPV calculations for latest 15minute Point-Of-Care tests authorized by FDA.
Figure #3: Details of NPV PPV calculations for Laboratory-Assays (1-3 days turn-around-time) authorized by FDA and used by Optimal Men’s Center in phase 2 testing.
Did You Notice?
Positive Predictive Value for the same exact test varies from virtually useless/dangerous to extremely helpful, depending on how many people have had the virus in the population being tested (Prevalence).
In many cases, because of false positives, we will not be able to tell whether a particular individual has recovered from covid19 and has developed antibodies / immunity or not. Yet we certainly will be able to see what percentage of people in our general population have fought Covid-19 and built antibodies to it (prevalence).
This is why Optimal Men’s Center has associated itself with other clinics in the USA in collection of data. We are pooling our information with others to provide the country our data about prevalence of the Covid-19 virus!