C4Diagnostics’ COVID-19 Rapid Saliva Test Cleared in Europe

C4Diagnostics has obtained CE mark certification for C4Covid-19 Human, a rapid coronavirus diagnostic that uses saliva samples to detect infection.

The in vitro diagnostic test is used with a portable reader-analyzer device to deliver test results in under 30 minutes.

C4Diagnostics says the test, which is based on reverse transcription loop-mediated isothermal amplification technology, offers performance comparable with reverse transcription polymerase chain reaction (RT-PCR) analyses of nasopharyngeal swabs.