Roche’s point-of-care polymerase chain reaction (PCR) test for pertussis (whooping cough) and other Bordetella infections has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE In Vitro Diagnostic Medical Devices Regulation (IVDR) certification. 

The test also secured a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver.

Designed to run on the cobas liat system, the test is said to deliver results in 15 minutes and can be used in the practices of general practitioners and emergency settings.