Monkeypox Virus Nucleic Acid
Detection Kit
(Fluorescence PCR Method)
Instructions for Use
The Monkeypox Virus Nucleic Acid Detection Kit is intended for the qualitative
detection of Monkeypox virus nucleic acid by Real-time Polymerase Chain Reaction
(Real-time PCR) method.
Results from the test are for the identification of DNA from Monkeypox virus existence
in samples tested. The Monkeypox virus DNA is mostly often detectable in vesicular or
pustular lesion fluid and diseased tissue samples collected during the acute phase of
infection.
Positive test results are indicative of the presence of Monkeypox virus DNA; whereas
clinical correlation with patient history and other diagnostic information is necessary for
the determination of patient infection status. Positive results from this test do not rule
out bacterial infection or co-infection with other viruses.
Negative test results do not completely preclude Monkeypox virus infection and should
not be used as the sole basis for patient management decisions. Negative results must
be used in combination with clinical observations, patient history, and epidemiological
information for a medical decision.
Interpretation of Test Results
If the Ct values of FAM channel are ≤40, the result can be considered Monkeypox
Virus nucleic acid Positive.
If the Ct values of the FAM channel are >40, the result can be considered
Monkeypox Virus nucleic acid Negative.
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