Antibody rapid tests are now out in Amarillo and Canyon, Texas, but health officials claim these tests are not FDA-approved and in some reported cases, provide inaccurate results. Amarillo health officials are warning the public to take caution when seeking the tests as they may give a sense of false security.
As of April 21, Amarillo had a total of 360 positive coronavirus cases. Dr. Robert Gross at CareXpress in Canyon reports that there have been many reports of the tests flagging people as containing antibodies to the coronavirus when they do not.
He adds that some of the tests are not designed to detect active infections, which could mislead an asymptomatic carrier of the virus into spreading the virus more when that person steps outside into the community.
Stephen Hahn, the FDA Commissioner, shares the same concern of the antibody tests being made available to the public, despite not being approved by the authority and with questionable accuracies.
Health administrators are expecting more unapproved tests to emerge and are urging residents in the Panhandle County to make sure the tests they take are FDA approved.
Gross stresses to the public that FDA-approved COVID-19 tests are available at CareXpress and provide accurate results within 24 hours. He adds that he understands that many are eager to go back to work and return to normal life; however, the steps in attaining that should be properly considered as safety still comes first.
Use FDA-Approved Coronavirus Antibody Tests, Nothing More
Reports claim that there have been dozens of antibody tests designed to detect antibodies to the coronavirus that were released in the market without approval from the FDA. Health officials worry that this might lead to false assurance in some and caution people only to take FDA-approved tests.
NBC News also reported that such tests were being used by public health departments in Denver and Los Angeles and were being provided to urgent care centers in Maryland and North Carolina. The test kits were supplied by Chinese manufacturers that are not approved by China's Center for Medical Device Evaluation, or NMPA, the country's equivalent of the U.S. Food and Drug Administration, it was later discovered.
Two U.S. drug companies, Premier Biotech of Minneapolis and Aytu Bioscience of Colorado, have been distributing the tests from unapproved Chinese manufacturers, according to health officials.
The unapproved tests were apparently shipped to the U.S. after the FDA loosened its guidelines for tests in mid-March and before the Chinese government banned their export just over two weeks later.
The use of antibody tests has been considered as a way to ensure that employees are healthy enough to go back to work and to find COVID-19 survivors who may be able to provide blood plasma to patients still struggling with their fight against COVID-19.
'Immunity Passports' Might be a No-Go
Experts have been trying to come up with ways to bring people back to work and have thought that immunity to the disease could eventually bring back the workforce.
However, information from the World Health Organisation claims that no more than two percent to three percent of the population have the antibodies to show the coronavirus infected them. These antibodies prove that a person has immunity to COVID-19. WHO experts now doubt whether immunity passports will work in getting people back to work.
WHO further warns the public that there is still no evidence to prove that coronavirus antibodies provide long term immunity and that not everyone who recovers from the disease develops antibodies.
