False Negative Results: Curative Test Of San-Dimas Gets Replace In LA County
COVID-19 PCR tests developed by San Dimas-based Curative at pop up sites get denied by the State Department of Health Services in Los Angeles.
The department's announcement on Sunday said that they will stop following the use of Curative tests by San Dimas as it brings false-negative results.
Days before, FDA also warned of issues with the Curative test which is widely used across the country. Lately the Curative defended the validity of its tests as a result of the alert given by the federal government on the possibility of false-negative results.
One week ago, the U.S Food and Drug Administration gave a warning to the patients and healthcare workers on the consequential risks of the Curative tests in providing false-negative results.
On Monday, an alert was issued by the Food and Drug Administration which warned people of the wrong results of the tests.
Since there is no specific problem identified with the company's tests, the authority also warned that the test must be carried out accordingly with its authorized use.
This limited the tests to be implemented only on people who show COVID-19 symptoms. However, in Los Angeles, the testing is open to anyone regardless if they show the symptoms or not.
LA mayor Eric Garcetti also defended the tests on Thursday and said that administering the Curative tests on people who don't show the symptoms had led the city to catch the virus in 92,000 people who might be left undetected even after they were tested.
The change made by the state would be followed this week after the FDA alert.
Officials said that the Fulgent Genetics test would be followed instead of the Curative test.
The Curative CEO Fred Turner said last week that the company is confidential with their data as they are working with the FDA closely on the matter, and they give the best priority to the testing sensitivity and accuracy on behalf of people.
According to the DHS officials, there is a risk of false-negative results in all COVID-19 tests. So a person may test negative even if he is contracted with the disease as the results are sensitive to how accurately the sample was collected and the concentration of viral RNA in it as well.
FDA said that the tests must be conducted according to the labeling, and conducted on people within 14 days of symptoms developed on him.
The FDA also asked people who take the self-administered test to conduct it under the observation of a healthcare worker.
The safety alert from the FDA on Monday said that the risk of the test is greater if it is taken not accordingly to the label, as the results may not be accurate. However, it is difficult to detect early infection, and the infection may spread before symptoms have time to develop as well.