Monkeypox Virue MPXV Antigen Repid Test For Professional In Vitro Diagnostic Use

INTERPRETATION OF RESULTS

Negative: Only a red line appears in the quality control area (C), and no line appears in the test area (T).

Positive: Two red lines appear. One is in the test area (T) and the other is in the quality control area (C).

Invalid: No red line displays in the quality control area (C). This indicates that the incorrect operation or the test cassette has deteriorated or damaged. Repeat the test with a new kit. If the problem persists, stop using this lot number immediately and contact your local supplier. Note: Invalid samples should be treated as infectious pollutants, and samples should be collected ag

Consider any materials of human origin as infectious and handle them using standard bio-safety procedures.

LIMITATIONS

1. The Monkeypox Virus Antigen Rapid Test Kit is an acute-phase screening test for qualitative detection. Sample collected may contain antigen concentration below the reagent’s sensitivity threshold, so a negative test result does not exclude infection with monkeypox virus. 2. The accuracy of the test depends on the sample collection, handing, storage and operation procedure. Improper sample collection, improper storage of samples, unfresh samples or repeated freeze-thaw cycles of samples will affect the test results.

3. A negative result may occur if the concentration of antigen in a specimen is below the detection limit of the test or if the specimen was collected or transported improperly, therefore a negative test result does not eliminate the possibility of monkeypox virus infection, and should be confirmed by viral culture or PCR.

4. The test result of this kit is for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment.

Technical Parameters:

PERFORMANCE CHARACTERISTIC

•  Analysis of Sensitivity and Specificity Detection of 5 MPV antigen positive corporate reference products, and the results were all positive. Detection of 10 MPV antigen negative corporate reference products, and the results were negative.
•  Cross Reactivity The kit show no cross reaction with microorganisms in the following table: