CDC updates guidelines for POC COVID-19 tests

May 14, 2020

The Centers for Disease Control and Prevention (CDC) updated its safety guidelines to address point-of-care (POC) testing of samples from patients suspected of being infected with SARS-CoV-2, the virus that causes COVID-19.

Noting that the Centers for Medicare & Medicaid Services (CMS) permits laboratories to extend their Certificate of Waiver to operate a temporary COVID-19 testing site in an off-site location, such as a long-term care facility, the CDC emphasized that the temporary site can only perform waived tests that are consistent with the lab’s existing certificate and are supervised by the lab director.

The CDC said labs should follow these key points when using POC instruments to diagnose cases of SARS-CoV-2: 

·        Use the instrument in a location associated with a current CLIA certificate.

·         Perform a site-specific and activity-specific risk assessment to identify and mitigate safety risks.

·         Train staff on the proper use of the instrument and ways to minimize the risk of exposures.

·         Follow standard precautions when handling clinical specimens, including hand hygiene and the use of PPE, such as laboratory coats or gowns, gloves, and eye protection. Additional precautions also can be used, such as a surgical mask or face shield, or other physical barriers, such as a splash shield to work behind.

·         When using patient swabs, minimize contamination of the swab stick and wrapper by widely opening the wrapper prior to placing the swab back into the wrapper.

·         Change gloves after adding patient specimens to the instrument.

·         Decontaminate the instrument after each run by using an EPA-approved disinfectant for SARS-CoV-2. Following the manufacturer’s recommendations for use, such as dilution, contact time, and safe handling.

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