July 27, 2022 – BD and CerTest Biotec today announced their newly developed molecular polymerase chain reaction (PCR) test for the monkeypox virus is now commercially available outside of the United States for use in research applications by laboratories.
The assay leveraged the BD MAX™ System open system reagent suite to develop the CerTest VIASURE Monkeypox molecular test on the BD MAX™ System.
“One of the key advantages of the BD MAX™ System is its open-architecture system that enables rapid response to emerging health threats,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD. “Just as we did at the beginning of the COVID-19 pandemic, we partnered with CerTest to quickly develop a molecular test to help better understand and track this disease.”
The BD MAX™ System is a fully 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. BD offers a suite of open system reagents for the BD MAX™ System that enables labs to fully automate and streamline their Lab Developed Tests.
“Speed is of the essence when responding to what the World Health Organization has declared a global health emergency,” Nelson Fernandes, managing director of CerTest Biotec. “We hope this new test will boost capacity for monkeypox research, ultimately helping quell the spread of the disease.”
As with all CerTest tests, the Monkeypox PCR Detection Kit for the BD MAX™ System is offered in a lyophilized format. Accordingly, the test 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.