HHS to conduct pilot program for rapid result COVID-19 tests in five states

The U.S. Department of Health and Human Services (HHS) is launching a pilot program for COVID-19 test kits that provide rapid results.

The pilot program for these portable, cartridge-based COVID-19 molecular test kits will be done in five states, Florida, Louisiana, New Jersey, Texas, and Alaska. These primary molecular point-of-care (POC) test kits were used by the National Basketball Association recently when it played games in the “bubble” in Orlando this past summer and fall. The nasal swab test generates results in about 20 minutes.

The Cue COVID-19 Test detects the virus’s ribonucleic acid (RNA), or genetic material, from a sample taken from the lower part of the nose using the Cue Sample Wand. The wand, or swab, is then inserted into the Cue COVID-19 Test Cartridge, coupled to the Cue Health Monitoring System, or Cue Cartridge Reader. After the cartridge reader analyzes the specimen, the device transmits the Cue Health App’s results on a connected mobile smart device.

Currently, HHS’s molecular COVID-19 tests must be sent to a laboratory for interpretation, which can take two to three days.

“The Cue Health testing system will undoubtedly be a valuable addition to our testing ecosystem,” HHS Assistant Secretary for Health ADM Brett Giroir said. “Having a highly specific and sensitive POC molecular test could dramatically improve infection control at nursing homes and other institutional settings especially.”

HHS distributed 27,000 test kits to the five states during the week of Nov. 9. The tests will also be used internally at the Department of Defense (DOD).

Currently, HHS sends millions of point-of-care rapid antigen tests with emergency use authorization (EUA) to states, nursing homes, and others. These antigen tests, which detect specific proteins from the SARS CoV-2 virus, are inexpensive and provide same-day results – often within minutes. While antigen tests are highly accurate, they can have false positives. The laboratory-based molecular tests – which HHS has also provided to states – may take two to three days.

“Our strategy continues to be to get the right test to the right person at the right time,” Giroir added. “We recommend that nursing homes and other institutions follow a layered approach to testing – using rapid, inexpensive, and frequent point-of-care tests for screening staff and verifying the results with more sophisticated molecular tests when the situation warrants. With Cue’s COVID-19 Test, verifying the antigen test results can be done on the spot in many cases. The pilot program will help us determine how well the Cue test will be adapted in institutions and communities.”

The pilot program is part of a $481 million contract with Cue Health awarded by HHS in collaboration with the Department of Defense. The partnership enables Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021. The contract calls for the delivery of 6 million COVID-19 tests and 30,000 cartridge readers to the U.S. government.