Laboratory validation and clinical performance of a saliva‐based test for monkeypox virus

Abstract

Improved diagnostic tests and accessibility are essential for controlling the outbreak of monkeypox. We describe a saliva‐based polymerase chain reaction (PCR) assay for monkeypox virus, in vitro test performance, and clinical implementation of that assay in Los Angeles, San Francisco, and Palm Springs, CA. Finally, using prespecified search terms, we conducted a systematic rapid review of PubMed and Web of Science online databases of studies reporting the performance of oral pharyngeal or saliva‐based tests for the monkeypox virus. The assay showed in silico inclusivity of 100% for 97 strains of monkeypox virus, with an analytic sensitivity of 250 copies/ml, and 100% agreement compared to known positive and negative specimens. Clinical testing identified 22 cases of monkeypox among 132 individuals (16.7%), of which 16 (72.7%) reported symptoms, 4 (18.2%) without a rash at the time of testing. Of an additional 18 patients with positive lesion tests, 16 (88.9%) had positive saliva tests. Our systematic review identified six studies; 100% of tests on oropharyngeal specimens from 23 patients agreed with the PCR test result of a lesion. Saliva‐based PCR tests are potential tools for case identification, and further evaluation of the performance of such tests is warranted.

Human Monkeypox: Oral Implications and Recommendations for Oral Screening and Infection Control in Dental Practice

“…Laboratory analysis showed strong agreement between tests based on saliva and swabs from mucocutaneous lesions [53].…”

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“…Therefore, both salivary and airborne ways of transmission are significant and should present awareness among healthcare workers ( Yang et al, 2023 ). Moreover, mpox testing can rely on saliva and air samples as materials for diagnosis ( Allan-Blitz et al, 2023 ; Figure 2 ).…”

Electrochemical Paper-Based Nanobiosensor for Rapid and Sensitive Detection of Monkeypox Virus

“…MPXV presents high human-to-human transmission, which may occur sexually and through large respiratory droplets, contact with skin lesions, or with infected bed and bath linen. − The first human case related to this disease was reported in 1970 in the Democratic Republic of Congo, and on July 23, 2022, it was formally recognized as a public health emergency of international concern (PHEIC) by World Health Organization (WHO) . Since then, around 87,000 cases were confirmed in more than 110 countries, which mainly included the USA (30,347 cases), Brazil (10,897 cases), and Spain (7549 cases). , …”