FDA clamps down on COVID-19 antibody tests!

Last Updated 15 Apr, 2020. Cellspect Co., Ltd.

The COVID-19 pandemic is an ongoing pandemic of coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2). Up to today, the number of confirmed cases is close to 4.3 million, and the number of deaths is close to 300,000 in the world. The current epidemic situation is still grim and complex.


Before the treatment of COVID-19, it is crucial to accurately identify the target patient, which is conducive to focusing the limited medical resources on the treatment of right patients. Recently, the American Food Drugs Administrative bureau (FDA) has begun to remove the COVID-19 diagnostic kit with low accuracy to avoid tragedies caused by erroneous test results.


Previously, the FDA was criticized for allowing hundreds of antibody tests against new coronaviruses in the US market without prior review and examination. The FDA now (May 7th) announced the accuracy standards for commercial testing products. Instead of using sensitivity and specificity, FDA uses the terms positive and negative agreements (PPA and NPA). The calculation method of these values ​​is the same as sensitivity and specificity, but it is used when the control test product is not perfect and generally needs other control, in this case, PCR detection of coronavirus RNA.


Specifically, the FDA pointed out that the data of the COVID-19 antibody test product needs to reach: PPA (equivalent to sensitivity) at least 90%, and NPA (equivalent to specificity) at least 95%. For test products that specifically report the results of IgM and IgG, PPA is required to be at least 70% and 90% for IgM and IgG, respectively. Meanwhile, at least 30 positive samples and 75 negative samples should be used to provide the consistency of data.


The following table summarizes some popular antibody test products known to be sold in the United States. So far, FDA has issued emergency use authorization (EUA) for 10 antibody test products. The FDA said that developers must provide supplement data within the next 10 days, otherwise their antibody testing products will face the risk of being withdrawn from the market.



In addition, FDA has developed an independent plan with the US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to double-check the accuracy of test products sold in the United States. The FDA said that so far, the cooperation has investigated 13 testing products. They announced that the data is still under review and will be public in the near future, showing their determination to popularize antibody testing and ensure its accuracy. This is also likely to be a standard for other countries to follow up.


  1. World Health Organization (WHO): www.who.int

  2. U.S. Food and Drug Administration (FDA): https://www.fda.gov/

  3. National Institutes of Health (NIH): https://www.nih.gov/

  4. FDA clamps down on Covid-19 antibody tests (FDA)

  5. EUA Authorized Serology Test Performance (FDA)

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