Home COVID-19 The List of COVID-19 Antibody Tests That Are Currently FDA-Approved

The List of COVID-19 Antibody Tests That Are Currently FDA-Approved

by Jennifer Tripucka
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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.

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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.

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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?

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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.

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/antibody in order to receive a test and will be sent an appointment time. Walk-ins will not be permitted. The City of Hoboken will pay for the cost of a test for any Hoboken resident who does not have health insurance — but there is no upfront cost for testing.

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: [email protected]

Got a news tip? Let us know — email us at [email protected]! We appreciate it.

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Did you know: We started a podcast about all things news and lifestyle in Hoboken + Jersey City! Listen to the latest episode of Tea on the Hudson here and subscribe.




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