Monkeypox Virus IgG/IgM Antibody Test

INTENDED USE
Monkeypox Virus IgG/IgM Antibody Test is intended for the In Vitro qualitative detection MPV IgG/IgM antibody
in human serum or plasma. It is only used as an auxiliary detection indicator for Monkeypox Virus (MPV) infection. This product can be used in a clinical setting/health-care setting/laboratory setting.

The samples are serum, plasma the test time is 10-15 minutes for simple, fast and efficient results.

1. Sensitivity
Detection of manufacturer’s sensitivity reference materials, the results are as follows:
1) IgG: S1 and S2 should be positive, S3 should be negative.
2) IgM: S1 and S2 should be positive, S3 should be negative.
2. Negative coincidence rate
Detection of manufacturer’s negative reference materials, the results are as follows:
1) IgG: negative coincidence rate (-/-) is no less than 24/25;
2) IgM: negative coincidence rate (-/-) is no less than 24/25.
3. Positive coincidence rate
Detection of manufacturer’s positive reference materials, the results are as follows:
1) IgG: positive coincidence rate (+/+) is no less than 10/10;
2) IgM: positive coincidence rate (+/+) is no less than 10/10;
4. Repeatability
Detection of manufacturer’s repeatability reference material in parallel for 10 times. The intensity of the test lines
should be consistent in color.
5. High dose hook effect
Test the high dose specimen, the result should be positive.

Storage: room temperature
Shelflife: 24 months