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COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below are links to the most recent messages about reporting false negatives and false positives from COVID-19 testing and new frequently asked questions, FDA updates on FAQs about testing for SARS-CoV-2, and new COVID-19 antigen testing guidance.
For laboratories using any Emergency Use Authorization (EUA)external icon assay, it is a best practice (and required under some letters of authorization) to report any suspected instances of false positive or false negative results to both the U.S. Food and Drug Administration (FDA) and the manufacturer.
Lab Update: FDA Updates FAQs about Testing for SARS-CoV-2
The U.S. Food and Drug Administration (FDA) recently updated the Frequently Asked Questions (FAQs) about testing for SARS-CoV-2 to include information about screening asymptomatic individuals for COVID-19:
- There is an updated answer to a question about commercial test kit manufacturers and clinical laboratories offering SARS-CoV-2 diagnostic tests to screen asymptomatic individuals for COVID-19.
- There is a new question and answer about recommendations for healthcare providers who are using SARS-CoV-2 diagnostic tests to screen asymptomatic patients for COVID-19.
New COVID-19 Antigen Testing Guidance
CDC recently issued new antigen testing guidance for evaluating and testing persons for Coronavirus Disease (COVID-19).
