Diagnostic Testing With In Vitro Diagnostic Monkeypox Virus Antigen Rapid Test Kit

INTENDED USE:

The Monkeypox Virus Antigen Rapid Test Kit is used to qualitatively detect Monkeypox antigen in human whole blood, lesion exudate, or scab samples. It is intended for in vitro diagnostic use only.

PRINCIPLE:

When the specimen is processed and added to the sample well, monkeypox virus antigens in the sample interact with the monkeypox virus antibody-labeled conjugate forming antigen-antibody color particle complexes. The complexes migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-monkeypox virus antibodies. A colored test line is visible in the result window if monkeypox virus antigens are present in the specimen and the intensity depends upon the amount of monkeypox virus antigen. When the monkeypox virus antigens in the specimen do not exist or are below the detection limit, there is not a visible colored band in the test line of the device. This indicates a negative result. Neither the test nor control lines are visible in the result window before applying the specimen. A visible control line is required to demonstrate the result is valid.

CAUTIONS:

1. This kit is for In Vitro Diagnostic use only.

2. For healthcare professionals and professionals at point of care sites.

3. Do not touch the reaction area of test strip.

4. Please read all the information in this leaflet before performing the test.

5. The test kit should remain in the sealed pouch until use.

6. All specimen should be considered potentially hazardous and handled in the same manner as an infectious agent.

7. Do not use test kit beyond the expiration date.

8. To avoid erroneous results, specimen must be processed as indicated in the test procedure section.

9. Testing should be applied by professionally trained staff working in certified laboratories or clinics at which the sample(s) is taken by qualified medical personnel. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection.

10. Do not reuse test cassette, sample extraction buffer, dropper or swab.

11. The test result should be interpreted by the physician along with clinical findings and other laboratory test results.

12. Disposal: All specimen and the used-kit have the infectious risk. The used test cassette should be discarded according to federal, state and local regulations