The Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR is a CLIA laboratory developed test that is also based on the CDC targets for the NVOs as well as West African clade.1, 2 It has been designed for high throughput specific testing. The CDC NVO Real-Time PCR Primer and Probe set has been granted 510K clearance by the FDA.
The key differences between the Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR and the CDC NVO DNA test are
1) The Quest developed Monkeypox virus DNA test is a dual-target assay. It can detect NVO DNA and detect the West African clade of the monkeypox virus DNA. Therefore, confirmatory testing is not needed with the dual target Monkeypox Virus DNA, Qualitative, Real-Time PCR test.3 The CDC NVO assay targets NVOs (see Table below).
2) The Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR test is performed from specimens collected in viral transport media, and the liquid media, not the swab, is used for testing. The CDC NVO PCR protocol requires that either a dry swab or a swab in media be processed for testing. Because the CDC protocol includes processing of the swab and not testing of the media, 2 swabs per lesion need to be collected so that 1 swab can be sent to the CDC for additional confirmatory testing if the NVO PCR is positive.
The table below shows the molecular targets of the Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR Test and the CDC non-Variola Orthopoxvirus DNA Test