The US FDA has warned that Abbott Laboratories’ (NYSE:ABT) rapid COVID-19 test might be having accuracy issues that might be due to user error. The FDA cited various studies that have raised concerns about the test’s accuracy when employed in making a quick diagnosis.
Abbott’s rapid test could be giving inaccurate results
Alex Azar, the Health and Human Services Secretary, indicated that the inaccuracy might be a result of “user error.” An interview with Fox Business Azar indicated that the White House was confident about the rapid test. He added that they would not have the test in the market without approval from US regulators that it worked.
The comments of Azar came after the FDA warned about the precision of the ID Now test of Abbott Laboratories. The test has been used to test White House employees, and the FDA warns that it could return more inaccurate negative results. This comes following instances where there have been negative results, and someone infected is told they don’t have COVID-19.
A New York University study that is yet to be peer-reviewed established that the ID NOW tests missed around 48% of positive coronavirus cases when dry nasal swabs were used. The test reportedly missed a third of the collected samples with nasopharyngeal swabs turned positive.
Abbott says test not correctly tested
Responding to the study Abbot indicated that there is a possibility that the samples might not have been tested correctly. On Friday, Azar said that it is wrong for users to collect samples and then transport them to be tested. He added that currently, Abbott is carrying out a post-market study, which is important for most companies, especially when dealing with emergency user authorization drugs.
A company spokesperson indicated that although the test might not be perfect various factors determine the outcome of a test. The spokesperson indicated that the test depends on specimen type, patient selection, handling, collection, storage as well as transportation as well as conformity on how the test is run.