COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Issues Safety Communication Warning of Potential False Negatives with Curative SARS-Cov-2 Test

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Curative SARS-Cov-2 diagnosis test providing high number of false negatives, FDA warns

The US Food and Drug Administration (FDA) released a safety communication Jan. 4, 2021, alerting patients and healthcare providers of “the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.”

This new year safety communication does not address the background of how the increased number of false-negative results were discovered, or the changes in sensitivity, that healthcare providers should expect with this test. It is also notable that the FDA has not rescinded or revised the EUA that the Curative SARS-Cov-2 test received.

With the safety communication, the FDA provided information about how to reduce false positives when using the test. “To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling, e.g., the Fact Sheet for Healthcare Providers,” states the FDA communication. “When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate.”

The FDA does not have any information on whether these false negatives are related to the way the test is typically performed or if the test itself is the underlying causative factor. The full recommendations given by the FDA may be reviewed here.

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