Laboratory validation and clinical performance of a saliva‐based test for monkeypox virus
This article has been Reviewed by the following groups
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- Evaluated articles (Rapid Reviews Infectious Diseases)
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.
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Evangelia Michailidou, Poulopoulos Athanasios
Review 2: "Laboratory Validation and Clinical Implementation of Human Monkeypox Saliva-Based Tests"
Reviewers found this study to be potentially informative to not informative, highlighting several gaps in the study design and reporting of results that render it difficult to draw meaningful conclusions from the preprint without major clarification or further research.
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Paulo Fernandes
Review 1: "Laboratory Validation and Clinical Implementation of Human Monkeypox Saliva-Based Tests"
Reviewers found this study to be potentially informative to not informative, highlighting several gaps in the study design and reporting of results that render it difficult to draw meaningful conclusions from the preprint without major clarification or further research.
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Paulo Fernandes, Evangelia Michailidou, Poulopoulos Athanasios
Reviews of: "Laboratory Validation and Clinical Implementation of Human Monkeypox Saliva-Based Tests"
Reviewers: P Fernandes (Instituto Politecnico de Viana do Castelo) | 📙📙 ◻️◻️◻️ • E Michailidou & P Athanasios (Aristotle University) | 📒📒📒◻️◻️
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