INTENDED USE

The Monkeypox Virus Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human whole blood, serum, plasma, rash exudate or throat swab specimen. It only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and using more specific alternative diagnosis methods to make final decision. This test is a screening test, and all positives must be confirmed using an alternate test. The test is intended for healthcare professional use only.