MPX IDx (Monkeypox virus qPCR Test)

MPX IDx (Monkeypox qPCR assay) is a real-time polymerase chain reaction (PCR) test for the qualitative detection of the monkeypox virus. This test is intended to confirm or rule out monkeypox virus in cases where a healthcare provider considers the possibility of monkeypox virus as the cause of a patient’s skin rash. This test is performed on a specimen (swab of the rash) taken by and submitted by a healthcare provider. MPX IDx assay involves extraction of the viral nucleic acid, followed by the amplification of the hemagglutinin (HA gene) target to detect the monkeypox virus. An internal control, the GAPDH gene target, which is readily available in all human skin samples is also targeted for amplification to ensure proper specimen collection, optimal extraction performance, and that the qPCR reaction was not inhibited.

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This test was developed, and its performance characteristics were determined by Ipsum Diagnostics LLC. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity clinical laboratory testing. This test is used for clinical purposes and should not be regarded as investigational or for research.

This assay is designed to detect the Monkeypox virus. It is not intended to specifically detect other orthopoxviruses.