The fully integrated, automated BD MAX System family performs nucleic acid extraction and real-time PCR to provide results in under three hours. Credit: BD / PRNewswire.

Becton, Dickinson and Company (BD) and CerTest Biotec have unveiled a new monkeypox virus molecular polymerase chain reaction (PCR) assay for research use only (RUO) applications by labs.

Named CerTest VIASURE Monkeypox molecular research use only assay, the test is commercially available across the globe, including in the US.

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The companies developed the assay using the BD MAX System open architecture reagent suite.

Based on US Food and Drug Administration (FDA) guidance issued on 7 September, BD is currently seeking to submit a monkeypox virus detection clinical test for emergency use authorization (EUA).

A completely incorporated, automated platform, the BD MAX System family carries out nucleic acid extraction as well as real-time PCR to deliver results for up to 24 samples across various syndromes in under three hours. 

BD provides a wide-ranging menu of tests on the system, including for healthcare-associated infections, sexually transmitted infections, respiratory infections, gastrointestinal infections and women’s health.

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As with all other CerTest assays, the monkeypox assay for the BD MAX System is available in a lyophilised form and is offered in a tube that fits into the test-specific area on the BD MAX ExK TNA extraction strip supplied by the company.

BD Molecular Diagnostics vice-president Nikos Pavlidis said: “Even before the US Department of Health and Human Services and FDA declared the ongoing monkeypox outbreak in the United States a public health emergency, we were working with CerTest to quickly develop a molecular assay to help better understand and track the disease. 

“Due to the Covid-19 pandemic, the installed base of our BD MAX System experienced explosive growth, providing greater access to this unique, open-architecture system that enables rapid response to emerging health threats like monkeypox.”

The companies partnered to develop a molecular diagnostic test for the monkeypox virus in June.

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