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Vast Majority of COVID-19 Family Antibody Testing Products not Meet Standards

COVID-19 Family Antibody Testing Products not Meet Standards

According to the Fox News website, the US FDA Commissioner and several public health laboratory officials have warned that the vast majority of COVID-19 blood antibody test products do not meet the standards.

Blood antibody test is different from the nucleic acid test

Eric Blank, a spokesman for the American Association of Public Health Laboratories, pointed out that the blood antibody test is different from the nucleic acid test of nasopharyngeal swabs currently widely carried out. It can identify viral antibodies in the blood. Diagnosis of various infectious diseases. In order to urgently respond to the US COVID-19 epidemic, the FDA has abandoned the initial review of blood test products.

At present, there are more than 70 companies selling so-called antibody detection products, the accuracy of which is in doubt, and no one knows which one is accurate.

Representation on COVID19 Family Antibody Testing Products not Meet Standards

Wild West Show

Blank said that this is like a "Wild West Show", which has caused huge confusion in disease prevention and control and will take some time to deal with.

US FDA Director Stephen Hahn pointed out that some companies have false propaganda. They claim that their blood test products are approved by the FDA and can be used to diagnose COVID-19.

At present, FDA has approved only one blood test product for clinical laboratories, so these products involve false marketing, and FDA will take action against these product companies.

Dr. Allison Rakeman of the New York City Public Health Laboratory said that medical experts currently have no consensus on the proportion of asymptomatic carriers of COVID-19, and the estimated range is between 25% and 50%. 

Wrong test results have made people less vigilant, thinking that they have been immunized or no longer spread the virus, and then they come in direct contact with the elderly from the outside-we do not want to create a false sense of security.

Officials in Laredo, Texas, reported this month that suspected patients can be tested at the local drop-off test point-they can drive to the test station by themselves, and they can be tested by medical staff without getting off the car. However, the 2,500 antibody detection products set up at these monitoring points are fraudulent. Government officials spot-checked the "FDA approved COVID-19 rapid test product" ordered by a local clinic, and its accuracy is far below the promised standard.

Deborah Birx, coordinator of the White House Coronavirus Task Force in the United States, pointed out in a recent press conference that the government will inform a test that is reliable for all Americans. If you see other products online, please do not buy them.

While the US official issued warnings about various test products, the reagent company also raised its own doubts. Dr. Stephen McColgan, chief medical officer of California-based Vivera Pharmaceuticals, said that the company's rapid antibody test submission has been three weeks ago, and the product has not been approved due to a large number of "red tape" processes.







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