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First Rapid Test Casualty: Chembio EUA Authorization Revoked

Scientists, doctors, and researchers have been working relentlessly on EUA approvals of Covid-19 antibody test kits. While there is no approved cure and vaccine yet, many strides have been made in understanding the virus. Observational data and clinical trials have played a significant role in unfolding more about Covid-19. As time progresses, different companies are rolling out test kits to support the journey of carrying out as many tests as possible to gather enough data to determine what can be done about the virus.

Chembio antibody tests are among the first tests to be EUA authorized by the Food and Drug Administration. At that time, Chembio submitted information to the FDA, which demonstrated that the test had met the standard requirements for emergency use authorization. As much as all tests have their set of drawbacks and benefits, according to the information submitted by Chembio, the benefits of the serology tests outweighed the drawbacks, hence the approval by FDA.

However, the requirements seem to have changed with time. More serology tests are being released, and the Food and Drug Administration has uncovered the capabilities of the tests that were not evident before. The FDA has since reviewed the performance requirements of serology tests. The expected performance of these tests needed for the users to make informed decisions regarding the control and management of the virus has been changed. Unfortunately, Chembio antibody tests are unable to meet performance expectations.

The tests have been found to generate false results that are higher than expected. The false results have also been found to be more than the ones that had been indicated in the labeling of the authorization of the test kit. This has demonstrated that the antibody kit cannot be relied on in detecting antibodies. The high number of false results generated by the tests is also a potential risk to public health. The FDA has decided to stop the distribution of the test for emergency use authorization by revoking it. 

Paul Singh, MHA, BA

​Covid Antibody Diagnostics​™

A Natures Body Wellness Corporation, Lake Mary FL 32746 

Find us on Google under Antibody Diagnostics

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