Description
INTENDED USEMonkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR Method) is used for the qualitative detection of the monkeypox virus nucleic acid in specimens of lesion surface swabs, lesion exudate or whole blood from suspected cases. Positive results are indicative of the presence of monkeypox virus nucleic acid, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with bacterial or 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. For professional use only. For in vitro diagnostic use only.
PRINCIPLE A highly conserved gene fragment of the Monkeypox virus(F3L) is used to generate probes and primers for the detection of Monkeypox virus infections in a real-time PCR assay. The conserved gene fragments of the Monkeypox virus are amplified accurately by the specific primers and detected by the TaqMan probes. During PCR amplification, reporter dye emits a characteristic wavelength as it is cleaved from its specific target DNA and from the quencher dye. Thus, Monkeypox virus nucleic acid can be found in the fully automatic enclosed reaction system. A synthetic non-competitive sequence was designed as an internal control template, which has no interference with the target gene of the Monkeypox virus. Specific probes and primes were designed according to the internal control template the probes to the internal control template were labeled at the 5' end with Sulfo-Cyanine5 (CY5) and at the 3' end with a quencher dye, which can effectively monitor the 2 / 8 occurrence of false-negative test results.
COMPONENTS a. The positive control and negative control need to be set to monitor the test body and the operating environment; the negative control and positive control have been packaged in the kit.
b. The components of different lots cannot be mixed for use.
c. Equipment or materials required but not provided: Specimen collection kits, Nucleic acid extraction kits; PCR tubes and caps, etc.
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