A lab worker prepares samples for the BD Max system. [Photo courtesy of BD]
Becton, Dickinson and Co and CerTest Biotec announced a partnership to develop a molecular diagnostic test for the monkeypox virus.
The CDC is tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus, which causes a rash and lesions. Monkeypox has been shown to be fatal in up to 10% of cases in Africa.
A “testing bottleneck” may be jeopardizing the ability to contain the virus, experts warned this week.
The automated BD Max platform’s open system reagent suite will validate the CerTest Viasure Monkeypox CE/IVD molecular test, BD said in a news release.
The Monkeypox PCR Detection Kit for the BD MAX system will be offered in a lyophilized format. The test will come in a tube that snaps into the test-specific position on the BD Max ExK TNA extraction strip, BD said.
“Enabling labs to rapidly respond to unexpected challenges is the kind of evolving health care situations for which the BD Max open system reagent suite is designed,” BD Molecular Diagnostics VP Nikos Pavlidis said in a news release.
BD Max performs nucleic acid extraction and real-time PCR, providing results for up to 24 samples across multiple syndromes in less than three hours, BD said. BD’s test menu covers healthcare-associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections, and women’s health diagnostics.
“The strong capabilities of our teams to rapidly develop molecular assays as well our experience working with the BD Max system enables us to accelerate the development of an assay and further build our collaboration with BD,” CerTest BioTec Managing Director Nelson Fernandes said in the news release.
The incubation time for monkeypox is usually 7-14 days, but can range from 5-21 days, the CDC said. The illness typically lasts two to four weeks, and starts with fever, headache, muscle aches, backache, swollen lymph nodes, chills and exhaustion.