Antibody tests for COVID-19 — the discussion that many are having as the reopening of businesses around the area comes to fruition. In March, the Food and Drug Administration issued a policy that allowed companies to validate their own tests and sell them, as long as they had a disclaimer that they hadn’t been approved by the FDA. But officials have found many companies making false claims about the accuracy of tests.
Antibody Testing 101
Per the FDA’s website, high-quality antibody tests can help us understand exposure to COVID-19, and a person who has been exposed to — and recovered from — COVID-19 will likely have antibodies to the SARS-CoV-2 virus in their blood.
These tests may be important for guiding our next steps in the fight against this pandemic, such as by providing information on disease prevalence and the frequency of asymptomatic infection, and also by identifying potential donors of ‘convalescent plasma,’ an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe or immediately life-threatening disease.”
See More: COVID-19 Testing Sites in New Jersey + Your FAQs Answered
The FDA Situation
The FDA has been actively approving antibody tests under EUA, or Emergency Use Authorization — which streamlines {and quickens} the rate of approval.
On their website, it’s stated that it is not accurate for developers to claim their test was authorized by the FDA if an EUA was not granted for the tests, “nor should they be distributing their test if it has not been properly validated,” which appears to be happening in certain testing situations.
The Validity and Accuracy of Tests
The big question on everyone’s mind: Are all tests created equal?
Right now, it seems the answer is no. According to Dr. Boguslavsky of Premier MD and BacktoWorkSolutions who provides antibody testing to his patients, “the accuracy can vary greatly.” He shares a great deal of information about antibody testing on our podcast here.
The *CURRENT* List of FDA-Approved Tests
Below is the current list of FDA-approved antibody tests for COVID-19. Please note that this is a growing list as more are receiving EUAs from the FDAs, but we highly encourage you to ask which test you are receiving and confirm the testing that the lab/cities are doing.
- – April 1: Cellex Inc. — qSARS-CoV-2 IgG/IgM Rapid Test
- – April 14: Ortho Clinical Diagnostics, Inc. — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
- – April 14: Chembio Diagnostic System, Inc — DPP COVID-19 IgM/IgG System
- – April 15: Mount Sinai Laboratory — COVID-19 ELISA IgG Antibody Test Serology IgG
- – April 24: Autobio Diagnostics Co. Ltd. — Anti-SARS-CoV-2 Rapid Test
- – April 24: Ortho-Clinical Diagnostics, Inc. — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
- – April 24: DiaSorin Inc. — LIAISON SARS-CoV-2 S1/S2 IgG
- – April 26: Abbott Laboratories Inc. — SARS-CoV-2 IgG assay
- – April 29: Bio-Rad Laboratories, Inc. — Platelia SARS-CoV-2 Total Ab assay
- – April 30: Wadsworth Center, New York State Department of Health — New York SARS-CoV Microsphere Immunoassay for Antibody Detection
- – May 2: Roche Diagnostics — Elecsys Anti-SARS-CoV-2
- – May 4: EUROIMMUN US Inc. — Anti-SARS-CoV-2 ELISA (IgG)
This FDA testing antibody information was provided here.
The Hoboken + Jersey City Antibody Testing
It’s worth noting that both the City of Hoboken Hoboken Antibody Test via Prompt MD — which, according to Dr. Barksdale, head of PromptMD, “is CE marked and is being used in over 15 other countries,” is still awaiting FD approval.
According to Mayor Bhalla’s press release last week, the Boditech’s AFIAS Rapid COVID-19 Antibody Tests offered at the Hoboken site tests individuals for IgG, which indicates whether or not an individual had COVID-19 in the past.
“Unlike certain other antibody tests, the Boditech rapid tests also tests for levels of IgM, the first antibody to appear in the response to initial exposure, which would indicate a current infection to COVID-19,” Mayor Bhalla shared.
“If an antibody test comes back positive for either IgG or IgM, the individual should not assume he or she has full immunity to COVID-19, and continue to take precautions including social distancing.”
Read More: If You Tested Positive for COVID-19 Antibodies via City MD, You Should Read This
Residents must register online at http://www.hobokennj.gov/
Meanwhile, in Jersey City, Mayor Fulop is also providing antibody testing to residents.
They signed a contract directly with a lab, though it’s unclear what lab it is and they have not yet responded to comment.
He shared on social media last week about the May 4th antibody testing kickoff, “We’ll start on Monday w/2100 tests per week {similar # to nasal swab that we’ll continue doing}. We’ll test our front line employees for the 1st part of next week then begin testing [the] public free of charge towards the end of next week,” he continued. “This is part of our initiatives around broader testing for our residents so that we can get the city functioning again. We will begin taking calls on Wednesday morning to schedule public appointments for antibody testing.”
This news came just 24 hours after the city announced that it would allow for COVID-19 testing to all residents with or without symptoms also on Monday, May 4th.
If you have Qs about the diagnostic test you’re receiving, phone FDA’s toll-free line 24 hours a day with questions: 1-888-INFO-FDA, choose option *
You can also email: COVID19DX@FDA.HHS.GOV
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