Monkeypox Antigen Fast Blood Test

Intended Use

Monkeypox Virus Antigen Test is intended for the In Vitro qualitative detection of Monkeypox Virus (MPV) antigen in human oropharyngeal swab, pustular fluid or anal swab as an aid in the diagnosis of MPV infections in conjunction with other laboratory and clinical findings. This product can be used in a clinical setting/health-care setting/laboratory setting.

Benefits

• Rapid: The result can be obtained in 10 minutes.

• Cost-effective: Machine is optional, you don't need to pay for machine to use the mpox test.

• Flexible: The monkeypox virus antigen test can be used in multiple scenarios, such as hospital, clinic, community, etc.

Product Specifications

※ Refer to Package Insert for additional product information.

Product Performance

1. Sensitivity

Detection of manufacturer’s sensitivity reference materials, the results are as follows: 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: Negative coincidence rate (-/-) is no less than 10/10.

3. Positive coincidence rate

Detection of manufacturer’s positive reference materials, the results are as follows: 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.

Application

Certifications