NEW YORK – DiaSorin Molecular announced Thursday its Simplexa COVID-19 Direct test has received CE marking for use with saliva samples.
The test previously received CE marking for use with nasal swabs, nasopharyngeal swabs, nasal wash and aspirates, and bronchoalveolar lavages. The addition of saliva samples will allow laboratories to increase capacity, overcome bottlenecks, and manage swab and transport media shortages, the company said in a statement.
Patients can self-collect their saliva samples in a healthcare facility using sterile cups, which reduces the risk of exposure for frontline healthcare workers.
Cypress, California-based DiaSorin's COVID-19 test can be used with the Liason MDX rt-PCR instrument in parallel with the firm's Simplexa Flu A/B and RSV Direct Gen II test, which received clearance from the US Food and Drug Administration earlier this month. The COVID-19 test kit received Emergency Use Authorization from the FDA in March.