Why some rapid COVID-19 antibody test kits are bad & inaccurate.
PLEASE NOTE: This article is being constantly updated as I receive new, accurate information about this on-going problem. Also, we have started two new websites:
KN95RespiratorMasksForSale.com: Group Buy deal for respirators, authentic PPE due to direct buy from factories in China (GROUPON for PPE).
PPEConnector.com: first online, open marketplace for qualified suppliers and end-users of authentic PPE
Apparently, the CEO of the Association of Public Health Laboratories said that some of the rapid COVID-19 antibody test kits are “crappy”. Let me tell you why we are flooded with “crappy” tests and why they are “crappy.” I have spent the past month, going through countless vendors trying to sell rapid test kits to us, Global Empowerment Mission. Please note that I am ONLY talking about the rapid COVID-19 antibody test kits from abroad and NOT other tests like Abbott RealTime SARS-CoV-2 assay (although Abbott has NOT published their false positive and negative rate, yet).
To address the COVID-19 diagnostic test shortages, the FDA issued an emergency use authorization for testing kits. According to the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, you are allowed to purchase non-FDA approved serology test kits for your hospital.
There are many vendors on the market. However, we, in the medical community, believe that accuracy matters the most when deciding on which kit to purchase. However, the FDA, in its rush to allow increase testing, didn’t evaluate the reliability of individual test kits. Instead, the FDA requested that each of the test reports must include the following statements:
· This test has not been reviewed by the FDA.
· Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
· Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
· Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
To put this in simple terms, this means that a negative COVID-19 antibody test result does NOT rule out an infection and that you should get a different test to make sure that you don’t have an infection. Also, a positive result does NOT mean that you had or have COVID-19, because this test also picks up other coronaviruses that cause the common cold.
Based on the Chinese medical provider’s experience we know of the following about this test.
“Positive serum-specific IgM, or specific IgG antibody titer in the recovery phase ≥4 times higher than that in the acute phase, can be used as diagnostic criteria for suspected patients with negative nucleic acid detection. During follow-up monitoring, IgM is detectable 10 days after symptom onset and IgG is detectable 12 days after symptom onset.”
To put this in simple terms, the rapid antibody test should be taken at least 10 days after the onset of your symptoms for the test to have some accuracy. Therefore, negative results do not preclude COVID-19 infection and should not be used as the sole basis for treatment or management decisions.
I have seen many of these COVID-19 antibody test kits package inserts and they are an assault on science. Above is a data that shows the reliability of one of the rapid COVID-19 test kit. It says that out of 77 people who were infected with COVID-19, 10 people tested negative (false negative), and 1 person tested positive (false positive). The total study only included 167 people.
The argument for these tests is that we can use these tests to screen people who had COVID-19 to put them back to work. But these tests are so “crappy”. Here is the final reason why. Many of these rapid COVID-19 test kits only cost $4 to $10 per kit. You get what you pay for.
Recently, the National Medical Products Administration of China published its approved novel coronavirus 2019-nCoV test kits. If you are going to buy anything, then I would purchase from their list. Please note, that they stated that antibody testing is only intended in combination with PCR testing.
P.S. For more articles about COVID-19:
Part 1: How to Spot a Fake KN95 Respirator Mask from China.
Part 2: How to identify suspicious, fake or misleading marks & certificates with your KN95 respirator mask.
Alternative Medicine Treatment for COVID-19?Zinc and Green tea.
How to verify a legitimate KN95 supplier?
P.P.S. For legal FDA questions, please contact Wayne H. Matelski, Counsel.
KN95RespiratorMasksForSale.com: Group Buy deal for respirators, authentic PPE due to direct buy from factories in China (GROUPON for PPE).
PPEConnector.com: first online, open marketplace for qualified suppliers and end-users of authentic PPE
