COVID-19 U.S. cases by county, as of July 26, 2020. (Source: Johns Hopkins University)

The Centers for Medicare & Medicaid Services has released the names of 636 nursing homes set to receive the first batch of COVID-19 point-of-care test devices.

As the agency indicated earlier this month, these facilities are located in “hot spots,” or those areas where the virus is spreading the most rapidly. A preponderance of this first grouping of facilities is in California, Florida, Texas, Alabama, Arizona, North Carolina and South Carolina.

CMS, which first disclosed the point-of-care testing program on July 14, has prioritized more than 3,900 nursing homes to receive instruments and tests in the coming weeks, the agency said in a frequently asked questions sheet. Once those shipments are complete, the Department of Health and Human Services will continue a phased distribution of antigen testing supplies to nursing homes with a current CLIA Certificate of Waiver and based on updated epidemiological data.

Besides a current CLIA Certificate of Waiver, CMS is prioritizing facilities with the following criteria: three or more confirmed or suspected new cases of COVID-19 in the last seven days; at least one new COVID-19 case in the last seven days after having zero previous COVID-19 cases; inadequate access to testing in the last seven days; at least one new resident death due to COVID-19 in the last seven days; and at least one new confirmed or suspected COVID-19 case among staff in the last seven days.

Facilities will receive at least one Quidel Sofia 2 Instrument or Becton, Dickinson and Company (BD) Veritor™ Plus System over the coming months along with the associated FDA-authorized antigen diagnostic tests, CMS said. Each test takes about 20 minutes to perform. “However, it is possible to run tests in an assembly line fashion to test 20­–30 samples per hour,” CMS said.  

A point-of-care, or antigen test, runs about $25. That compares to approximately $100 for a polymerase chain reaction (PCR) test. While the cost and timeliness are positive attributes of the point-of-care tests, there are also some drawbacks, such as the sensitivity, which is less than a PCR test.