NEW YORK — Opti Medical Systems said on Friday that it has received CE marking for its PCR-based SARS-CoV-2 test kit.
The Opti SARS-CoV-2 RT-PCR kit is designed to detect viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage, and sputum samples. It provides results within three and a half hours, the company said.
The kit received Emergency Use Authorization (EUA) from the US Food and Drug Administration in May.
Roswell, Georgia-based Opti, which is a subsidiary of Idexx Laboratories, also said on Friday that it has received EUA from the FDA for its Opti DNA/RNA Magnetic Bead Kit for nucleic acid extraction from respiratory samples for use with its SARS-CoV-2 test kit.
With the latest EUA, Opti said it can provide a complete workflow for SARS-CoV-2 testing in the US.