The growing statistics of infected persons of COVID-19 in the United States are prompting health officials to conduct more tests to diagnose infections and to identify those recovered patients with antibodies in hopes that it could help in the fight against the deadly disease.
However, some unapproved antibody tests were administered to patients in two states in the U.S. These antibody tests are now being used by the health departments in Denver and Los Angeles, as well as to urgent care centers in Maryland and North Carolina.
Unapproved antibodies tests
The antibody tests were supplied by manufacturers from China, however, NBC News reports that these tests are unapproved by the Chinese government's Center for Medical Device Evaluation, a unit of the National Medical Product Administration. It is the country's equivalent to the United States' Food and Drug Administration.
Manufacturers of the tests namely the Premier Biotech of Minneapolis and Aytu Bioscience of Colorado, both US companies have been distributing the tests from unapproved Chinese manufacturers, the health officials said.
It appears that after the U.S. has relaxed its restrictions for tests in mid-March and before China has banned its export, two weeks later the unapproved tests were shipped to the U.S. and used in hospitals.
An unapproved antibody tests could give false results and therefore rendered to be unreliable.
Scott Becker, the Association of Public Health Laboratories director have expressed concern about the reliability of these tests. He said that any U.S. companies that are selling tests to hospitals and public health agencies should push to have FDA evaluate them first to the multi-agency study before administering it to people.
Testing the antibody tests
FDA is more pressured to accelerate and expand the availability of COVID-19 diagnostic tests after receiving criticisms from the public regarding the slow pace of test approval in the U.S.
FDA has relaxed its policies and allowed the massive distribution of testing kits even though it is not yet approved. This happened after the Department of Health and Human Services said on March 16 that the pandemic justified the authorization of emergency use of the testing kits.
Meanwhile in China, the NMPA that is known to be 'rigorous' and 'demanding' has been reviewing COVID-19 test kits since earlier this year to make sure that the test kits meet the requirements of safety, effectiveness and quality control.
They published their most recent list of approved COVID-19 test manufacturers on April 2 after announcing that the country is restricting the export of medical materials on March 31. This restriction aimed to "strictly control quality, maintain export order, and crackdown on counterfeit and shoddy products.
However, the tests administered to the hospitals in the two states of the U.S. were not included in the list. Both Hangzhou Biotest Biotech Co. and Zhejiang Orient Gene Biotech's test although unapproved showed no indication of being unreliable.
