Monkeypox Virus Detection Kit (PCR-Fluorescent Probe) - IFU
The Monkeypox Virus Detection Kit (PCR-Fluorescent Probe) is an in vitro diagnostic kit intended for the qualitative detection of Monkeypox Virus Nucleic Acids in symptomatic patients within 1-14 days of symptom onset. The kit can be used to assess samples from skin swabs (papule or vesicle) and is suitable for use from the onset of symptoms. It is intended for use as an aid in the qualitative diagnosis of infection with the Monkeypox virus in the specified population. The clinical utility of the test is as an aid in the diagnosis of Monkeypox virus infection.
The kit is designed for use with skin swab samples, and blood samples should not be used with this device. The test method employed by the kit is qualitative RT- PCR. This product is for professional in vitro diagnostic use only and is supported by validation studies.
Monkeypox is a viral zoonosis with symptoms similar to those seen in the past in smallpox patients. Since 1980 with the eradication of smallpox, monkeypox has emerged as the most important orthopoxvirus for public health. In recent times, the case fatality ratio of monkeypox has historically ranged around
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