Nova Test Monkeypox Virus Real Time PCR Test Kit

NAME

NOVA Test' Monkeypox Virus Real Time PCR Test Kit

INTENDED USE

The NOVA Test® Monkeypox Virus Real Time PCR Test Kit is a real-time (rt) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from monkeypox in skin lesion exudate swabs, lesion roofs and lesion crusts material collected at a healthcare location or collected by a healthcare provider, from individuals suspected of monkeypox infection by their healthcare provider. Testing is limited to professional use.

Results are for the identification of Monkeypox virus DNA. The Monkeypox virus DNA is generally detectable in skin lesion specimens during the acute phase of infection. Positive results are indicative of the presence of Monkeypox virus DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

Positive results do not rule out bacterial infection or co-Infection with other viruses.

Negative results do not preclude Monkeypox virus infection and should not be used as the

sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The NOVA Test`"' Monkeypox Virus Real Time PCR Test Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time FOR and in vitro diagnostic procedures. For in vitro diagnostic use only.

SUMMARY

The monkeypox virus is the causative pathogen of monkeypox, which is a viral zoonotic

disease with symptoms in humans similar to those seen in smallpox patients. Early symptoms include fever, headache, muscle pains, fatigue, and swollen glands. After a few days of early symptoms, patients may develop a few to thousands of characteristic lesions on the face,

hands, and feet. The monkeypox virus can be found in the patients' body fluid and

contaminated belongings, and spread by close contact with contaminated items.

METHOD

The NOVA Test Monkeypox Virus Real Time PCR Test Kit is based on fluorescent modification of the FOR method. The FOR-mix contains target-specific probes bearing reporter fluorescent dyes and quencher molecules. Once hybridized to a target sequence, the probes become activated. As a result of activation fluorescence increases proportionally to target sequence amplification. The intensity of fluorescence is measured at every cycle of reaction with a Real-time PCR thermal cycler data collection unit and analyzed with the software provided.

The PCR-m ix includes the Internal control (IC), which is intended to assess the quality of the polymerase chain reaction. DNA probes used for the detection of the Monkeypox Virus product amplification include fluorescent dyes Fam and Cy5. DNA probe used for the detection of the internal control amplification product includes the fluorescent dye Hex.

Table-I Detection channels of amplification products

REAGENTS

1.Monkeypox Virus Internal Control (4 vials, 1.2mL per vial)

2.PCR Amplification Buffer (96 tests)