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Rapid Adaptation of Established High-Throughput Molecular Testing Infrastructure for Monkeypox Virus Detection

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

in Automation / COVID-19 / Diagnosis / Diagnostic tests / Expedited / high-throughput PCR testing / Human monkeypox / Humans / Medical diagnosis / Molecular Diagnostic Techniques / molecular diagnostics / monkeypox virus / Monkeypox virus - genetics / Mpox / Mpox (monkeypox) - diagnosis / Mpox (monkeypox) - epidemiology / Pandemics / Patients / Polymerase chain reaction / Process controls / Rapid Adaptation of Established High-Throughput Molecular Testing Infrastructure for Monkeypox Virus Detection / Reference materials / SARS-CoV-2 / SARS-CoV-2 - genetics / Sensitivity and Specificity / Severe acute respiratory syndrome coronavirus 2 / Software / Urine / Vaccines / Viruses / zoonoses

2022

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Rapid Adaptation of Established High-Throughput Molecular Testing Infrastructure for Monkeypox Virus Detection

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

2022

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Rapid Adaptation of Established High-Throughput Molecular Testing Infrastructure for Monkeypox Virus Detection

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

2022

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Journal Article

Rapid Adaptation of Established High-Throughput Molecular Testing Infrastructure for Monkeypox Virus Detection

Emmerich, Petra,

Nörz, Dominik,

Giersch, Katja,

Lütgehetmann, Marc,

Aepfelbacher, Martin,

Schmiedel, Stephan,

Addo, Marylyn M.,

Pfefferle, Susanne,

Fischer, Nicole,

Tang, Hui Ting

2022

Overview

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.

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Publisher

U.S. National Center for Infectious Diseases,Centers for Disease Control and Prevention

Subject

/ high-throughput PCR testing

/ Human monkeypox