Only 4 COVID-19 Antibody Test Devices Approved by US FDA... Most Sold Without Approval

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) has allowed the sale of novel coronavirus (COVID-19) antibody testing devices without prior review, raising concerns about their accuracy and potential side effects. If these devices prove to be inaccurate, it could cause significant confusion not only for public health authorities and medical systems but also for patients.

According to the Washington Post (WP) on the 19th (local time), among the approximately 90 antibody testing devices currently distributed in the U.S., only four have received FDA approval. This is because, since mid-last month, manufacturers have been permitted to sell products after conducting their own verification and simply notifying the FDA to enable rapid antibody testing.

WP pointed out that some companies are selling antibody testing devices with significantly poor performance or engaging in false marketing, which has increased side effect concerns. In particular, cases of malfunctioning devices manufactured overseas, including in China, have been reported, continuously raising issues about accuracy.

With testing methods that have not undergone FDA review becoming widespread, there is growing concern that if these devices are inaccurate, they could confuse doctors, hospitals, and patients alike. Kelly Broblesski, Director of the Infectious Disease Program at the Association of Public Health Laboratories (APHL), told WP, "We need to closely examine tests that have not been FDA-approved," adding, "Many inaccurate tests are worse than not testing at all."

In response to these concerns, the FDA is reportedly working with other institutions, including the National Cancer Institute, to evaluate whether unreviewed tests function properly.

This content was produced with the assistance of AI translation services.