Monkeypox Virus Real Time PCR Kit CE/IVD

Intended Use

The Bioperfectus Monkeypox Virus Real Time PCR Kit is based on real-time PCR technology, for the detection of DNA from the Monkeypox virus. Specimens can be obtained from human serum, lesion exudate samples and scab. BSL-2 facilities with standard BSL-2 work practices may be used for the test of the Monkeypox virus.

For Research Use Only (RUO)
For use with Bioperfectus STC-96A, STC-96A PLUS, Applied Biosystems 7500, QuantStudio™ 5, Roche LightCycler®480, Bio-Rad CFX96™, QIAGEN Rotor-Gene Q, Analytik Jena qTOWER3 and other applicable Bioperfectus machines.

Kit Components
Components                         Vials/Kit            Volume/25T          Volume /50T
PCR Reaction Mix                   1                      313 μL                625 μL
Detection Mix                         1                      188 μL                375 μL
Positive Control                     1                      25 μL                  50 μL
Blank Control                        1                      250 μL                250 μL

Performance Evaluation
Analytical Sensitivity

The limit of detection of the Bioperfectus Monkeypox Virus Real Time PCR Kit for the detection of DNA specific for Monkeypox virus from human serum or lesion exudate samples was determined to be 5 copies/reaction.

Analytical Specificity
No cross-reactivity of the Kit within the following selected microorganisms were observed.
Pathogen
Measles virus

Rubella virus
Varicella-zoster virus

Herpes simplex virus
EB virus

Cytomegalovirus
Human herpesvirus 6

Human herpesvirus 7
Human herpesvirus 8 /

Precision

Precision references were used to evaluate the precision of Bioperfectus Monkeypox Virus Real Time PCR Kit. The results show that, for the precision references, coefficients of variation (CV%) of the repeatability and within-laboratory precision are less than 5%.