This study assessed how well a new extraction-free assay called the Pluslife RHAM test works for finding monkeypox virus. The test was compared to the standard diagnostic real-time PCR method using 206 clinical specimens. These samples included swabs from lesions, the mouth, and rectum, as well as urine, semen, and wound fluid collected at the German Consultant Laboratory for Poxviruses.
The main results showed that the new test had a diagnostic sensitivity of 94.2% and a specificity of 100%. This means it correctly identified the virus in most positive cases and never gave a false positive result. The test also successfully detected all four known clades of the monkeypox virus and showed no cross-reactivity with other poxviruses or common pathogens.
The researchers noted that the test performed best in samples with higher viral loads, reaching 100% sensitivity when the cycle threshold was below 30. No safety concerns were reported because adverse events were not applicable to this diagnostic test evaluation. Readers should understand that while this is a practical solution for resource-limited settings, the findings come from a specific laboratory context and may need further confirmation in broader clinical use.