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CE mark

The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.

The firm's assay is also CE marked for use with nasal swabs, nasopharyngeal swabs, nasal wash and aspirates, and bronchoalveolar lavages.

About a year ago, the California company received approval for the flow cytometer from the China National Medical Products Administration.

The test can be used directly on any open instrument, including portable systems, and it allows for detection of pathogens in about 75 minutes.

Overall, GenMark's ePlex Respiratory Pathogen Panel 2 provides results for more than 20 viruses and bacteria, including SARS-CoV-2, flu A and B, RSV, and rhinovirus.

The test provides results for therapeutic drug monitoring in less than five minutes using fingerpick blood.

Veravas' products are used for the detection of biotin, which is often found in multivitamins and over-the-counter health supplements and can interfere with diagnostic test results.

The point-of-care test provides results in 15 minutes and can be used for both symptomatic and asymptomatic patients.

The companies are positioning the test, called SeptiCyte Rapid, for use in triaging COVID-19 patients who could be at greater risk for progressing to sepsis.

 

The PCR-based panel is designed to differentiate between SARS-CoV-2 and other common winter infections with high specificity and sensitivity.

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