Viral infectious disease IVDs

Intended purpose

The HA TECH Monkeypox Virus PCR Diagnostic Kit is a real time PCR test designed for the qualitative and specific detection of DNA from Monkeypox Virus in human biological samples including lesion fluid on the dry swab, lesion fluid swab in viral transport media, lesion crust, or lesion roof. Recommended biological specimens for laboratory diagnosis of monkeypox are skin lesion material. DNA extract solely from whole blood alone is not a suitable specimen for Monkeypox virus diagnostic testing as the viremic phase may have already passed at the time of rash onset. As such, a negative result from only a whole blood specimen cannot rule out a Monkeypox virus infection.