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Early Release: Rapid Adaptation of Established High-Throughput Molecular Testing Infrastructure for Monkeypox Virus Detection - CDC

Mary Wilson

Well-known member
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released.

Volume 28, Number 9—September 2022

https://doi.org/10.3201/eid2809.220917

Dominik Nörz, Hui Ting Tang, Petra Emmerich, Katja Giersch, Nicole Fischer, Stephan Schmiedel, Marylyn M. Addo, Martin Aepfelbacher, Susanne Pfefferle, and Marc Lütgehetmann

Abstract

Beginning in May 2022, a rising number of monkeypox cases were reported in non–monkeypox-endemic countries in the Northern Hemisphere. We adapted 2 published quantitative PCRs for use as a dual-target monkeypox virus test on widely used automated high-throughput PCR systems. We determined analytic performance by serial dilutions of monkeypox virus reference material, which we quantified by digital PCR. We found the lower limit of detection for the combined assays was 4.795 (95% CI 3.6–8.6) copies/mL. We compared clinical performance against a commercial manual orthopoxvirus research use only PCR kit by using clinical remnant swab samples. Our assay showed 100% positive (n = 11) and 100% negative (n = 56) agreement. Timely and scalable PCR tests are crucial for limiting further spread of monkeypox. The assay we provide streamlines high-throughput molecular testing for monkeypox virus on existing broadly established platforms used for SARS-CoV-2 diagnostic testing.

https://wwwnc.cdc.gov/eid/article/28/9/22-0917_article#suggestedcitation
 
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