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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) | 📒📒📒◻️◻️

Published onSep 07, 2022
Reviews of: "Laboratory Validation and Clinical Implementation of Human Monkeypox Saliva-Based Tests"
key-enterThis Pub is a Review of
Laboratory Validation and Clinical Implementation of Human Monkeypox Saliva-Based Tests
Description

AbstractBackgroundImproved diagnostic capabilities and accessibility are essential for controlling the outbreak of Human Monkeypox.MethodsWe describe a saliva-based polymerase chain reaction (PCR) assay for Human Monkeypox, in vitro test performance, and 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 oral pharyngeal or saliva-based tests for Human Monkeypox.ResultsLaboratory evaluation of the assay showed in silico inclusivity of 100% for 97 strains of Human Monkeypox, with an analytic sensitivity of 250 copies/mL, and 100% agreement compared to known positive and negative specimens. Clinical testing identified 22 cases of Human Monkeypox among 132 individuals (16.7%). Of those 22 cases, 16 (72.7%) reported symptoms, 4 (18.2%) without a rash at the time of testing. Our systematic rapid review identified 6 studies; 23 patients had tests performed on oropharyngeal specimens 100% agreed with the PCR test result of a lesion swab.ConclusionSaliva-based PCR tests are potential tools for outbreak control, and further evaluation of the performance of such tests is warranted.

To read the original manuscript, click the link above.

Summary of Reviews: This preprint describes a saliva-based polymerase chain reaction (PCR) assay for Human Monkeypox Virus and assesses its in vitro test performance and clinical performance. 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.

Reviewer 1 (Paulo F…) | 📙📙 ◻️◻️◻️

Co-Reviewer 2 (Evangelia M…) | 📒📒📒 ◻️◻️

Co- Reviewer 2 (Poulopoulos A…) | 📒📒📒 ◻️◻️

RR:C19 Strength of Evidence Scale Key

📕 ◻️◻️◻️◻️ = Misleading

📙📙 ◻️◻️◻️ = Not Informative

📒📒📒 ◻️◻️ = Potentially Informative

📗📗📗📗◻️ = Reliable

📘📘📘📘📘 = Strong

To read the reviews, click the links below. 


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