The United States government along with the Food and Drug Administration is planning a restructure of all antibody tests providing plans. A new plan is in the process. It requires all commercially available antibody test kit makers to meet the revised standards of accuracy. All commercial and researcher related antibody test kit producers need to submit official documentation surrounding the testing quality.
The agency is reversing its March 16 policy, according to which, however, anyone can provide antibody test kits without proper accuracy tests. But the commercial test providers will now have 10 days to submit proper scientific documentation along with accuracy. The agency recommends organizations need to be at par with the “sensitivity and specificity” according to guidelines.
FDA disapproves commercial antibody tests
Public health officials are spreading awareness to question the accuracy of all such Coronavirus detection tests. But canceling all such test providers is not the right way to do it. Proper guidelines need to be there, following which people need to question the accuracy of the test.
— Roche (@Roche) May 3, 2020
FDA’s initial policy gave a green signal for anyone to start making a COVID-19 detection kit. But it turns out that they never thought it will lead to fraud. The official notification, released by Dr. Stephen M. Hahn, says that all commercial test kits need to pass the accuracy test. The most common test in the environment is the serology test, used to detect coronavirus. These tests are quite different from the traditional PCR tests.
Many people are using this advantage to make fraudulent kits and duping people. This is very unethical and needs to be stopped. But, recently a large community mass testing in New York has been sanctioned. This will help determine the test results more accurately.
Almost 200 test kit providers started production after the March 16 policy. However, it turns out almost 70% of them do not have accurate results to back their product. Some even claimed that the test kits can work from home. But even here, there was no surety.
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