For many months as the Coronavirus pandemic worsened, our efforts to attract the attention of local Maryland politicians and health officials has been met with stony silence punctuated with quick dismissal of our FDA EUA authorized OrientGene/ Healgen rapid antibody tests as being without merit.
There are four reasons why decision makers are struggling to see the importance of rapid antibody testing.
1. Bad actors introduced poor quality tests that were not accurate or did not work at all.
Back in April the New York Times began writing a series of articles that burst the hype bubble surrounding antibody tests by pointing to dubious results and downright fraud .
Headlines like: “The UK Paid $20 Million for New Coronavirus Tests. They Didn’t Work” had an immediate chilling effect.
Spain made news as well for a shipment of 640,000 faulty antibody tests sold by a company that even the Chinese government said had no authorization to distribute their product.
People got scared by negative press, and a knee-jerk dismissal is much easier than taking time to consider the possibility that the OrientGene/ Healgen rapid antibody test is different.
By the way, after Spain switched over to our OrientGene/Healgen rapid antibody tests they were thrilled with the results; and they used them as a finger-prick blood test!
2. They are asking the wrong question(s) .
People are hung up answering the: “Is this person currently infected question” instead of asking global questions like:
“What is the rate of infection in this community?”
“How many people have developed antibodies to SARS-CoV-2?”
“How long can IgG antibodies be detected post infection?
These questions cannot be answered by RT-PCR testing.
A rapid antibody test has more relevance for addressing questions about re-starting the economy than resolving doubt about a specific patient.
And even if we want to make the rapid antibody test conversation about diagnostics, when Business Insider examined the pool of antibody tests for accuracy they found the OrientGene/Healgen test delivered 100% sensitivity reporting IgM.
3. People have been duped into believing PCR tests are some sort of gold standard (when the level of accuracy is not even close to 100%).
Basically, if it isn’t PCR, it isn’t relevant.
So much has been said about this already. This belief will unravel on its own.
The Coronavirus testing landscape is changing by the day with exciting new entries like the Sofia 2 antigen test by Quidel and a crop of CRiSPR based SARS-CoV-2 rapid tests which eliminate the need for five-figure real-time thermal cyclers needed for RT-PCR testing.
It is a question of when, not if.
4. They do not yet grasp the severity of the bottleneck which make many RT-PCR tests irrelevant by the time the results are reported.
The whole point of PCR testing is to know if someone is infected NOW. But if it takes two weeks or more to get results, they best you can say is “they were or were not infected THEN.”
To perform RT-PCR a whole supply chain of plastic consumables and reagents need to be in sync, starting with sample collection through the end-product.
The PCR testing situation is a tragic mess and the TAT (turnaround time) lag is helping nobody.
The facts in favor of rapid antibody testing for SARS-CoV-2 are:
Antibody tests are inexpensive
Finger-prick antibody tests require no specialized equipment to perform
Rapid antibody tests have no cold chain management issues. Samples are processed immediately and do not expire or go bad.
The results are as advertised – rapid – usually within fifteen minutes or less.
Mounds and mounds of data can be created quickly to better inform policy makers what their community COVID-19 map looks like.
If you make the choice to have antibody testing as part of your overall COVID-19 testing strategy, the OrientGene/Healgen rapid antibody tests from Stellar Scientific is a smart decision.