Corona Virus - Microbiology And Virology Concept - 3d Rendering

Point of Care Testing – Are You Prepared?

Angie SzumlinskiCompliance

Last week, Administrator Verma held a nursing home call announcing that “Point of Care” testing will be made available to all long-term care facilities in the country, beginning with those located in high-risk hot spots first. The Quidel Corporation’s Sofia 2 SARS Antigen Fluorescent Immunoassay (FIA) received an emergency use authorization from the FDA on May 8, 2020, and is approved for point of care testing by facilities under a CLIA Certificate of Waiver.

This antigen test can provide results in minutes; however, antigen tests may not detect all active infections, based on their mechanism of action. These tests are very specific for the virus but are not as sensitive as molecular polymerase chain reaction (PCR) tests. Therefore, positive results from antigen tests are highly accurate but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.

It is highly recommended that you prepare your center if you are not already performing point of care testing. Preparations should include training staff on the appropriate method of obtaining a specimen, how the testing kits work, how the testing equipment operates, etc. More importantly, each center should be sure that their CLIA waiver is current and posted as required. Remember, point of care testing cannot be performed without it!

The links below provide additional guidance and the video recording of the Nursing Home Call that was held on July 15th. Our HealthCap Risk Management Resource and Education Center also provides policies and procedures for testing. Stay well, stay safe and stay tuned!

CDC Testing Guidance

Nursing Home Call Recording