BD and CerTest Biotec today announced their newly developed molecular polymerase chain reaction (PCR) assay for monkeypox virus is now commercially available globally, including in the United States, for research use only applications by laboratories.
The teams used the BD MAX System open architecture reagent suite to develop the CerTest VIASURE Monkeypox molecular research use only assay. BD is working to submit a clinical test for monkeypox virus for emergency used authorization (EUA) as soon as possible, based on the guidance issued by the FDA on September 7.
The BD MAX System family is an integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours. BD offers an extensive menu of tests on the system covering health care associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections and women's health.
As with all CerTest assays, the CerTest VIASURE Monkeypox virus PCR Detection RUO assay for the BD MAX System is offered in a lyophilized format. Accordingly, the assay will come in a tube that snaps into the test-specific position on the BD MAX ExK TNA extraction strip, which is supplied by BD.
