Background: Improved diagnostic capabilities and accessibility are essential for controlling the outbreak of Human Monkeypox.
Methods
We developed a saliva-based polymerase chain reaction (PCR) for Human Monkeypox, evaluated in vitro test performance, as well as report on clinical implementation of that assay at three testing sites in Los Angeles. Finally, using pre-specified search terms, we conducted a systematic rapid review of PubMed and Web of Science online databases of studies reporting the performance of saliva-based tests for Human Monkeypox.
Results
Laboratory evaluation of the assay showed in silico inclusivity of 100% for all (n=97) strains of Human Monkeypox, with an analytic sensitivity of 250 copies/mL, as well as 100% agreement compared to known positive and negative specimens. Clinical testing identified 15 cases of Human Monkeypox among 114 individuals screened (13.2%). Of those, 11 (73.3%) reported symptoms, two of whom had not developed a rash. Our systematic rapid review identified 6 studies; 23 patients had tests performed on oropharyngeal specimens 100% of which were in agreement with the PCR test of a lesion swab.
Conclusion:
Saliva-based PCR tests are potential tools for outbreak control, and further evaluation of the performance of such tests is warranted.