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Wettengel, J.M. ; Bunse, T. ; Jeske, S.D.* ; Wölfel, R.* ; Zange, S.* ; Taeubner, J.* ; Goelnitz, U.* ; Protzer, U.

Implementation and clinical evaluation of an Mpox virus laboratory-developed test on a fully automated random-access platform.

J. Med. Virol. 95:e29022 (2023)
Verlagsversion DOI PMC
Open Access Gold (Paid Option)
Creative Commons Lizenzvertrag
While Mpox virus (MPXV) diagnostics were performed in specialized laboratories only, the global emergence of Mpox cases in 2022 revealed the need for a more readily available diagnostic. Automated random-access platforms with fast nucleic acid extraction and PCR have become established in many laboratories, providing faster and more accessible testing. In this study, we adapted a previously published generic MPXV-PCR as a lab-developed test (LDT) on a NeuMoDx Molecular System and isolated MPXV clones from patient materials. To reduce the handling of infectious material, we evaluated a viral lysis buffer (VLB) for sample pretreatment. We further compared the MPXV-LDT-PCR to conventional real-time PCR, determined its sensitivity and specificity using positive swabs, and assessed its performance using external quality assessment samples. Pretreatment of samples with 50% VLB reduced MPXV infectivity by approximately 200-fold while maintaining PCR sensitivity. The assay demonstrated a sensitivity and specificity of 100% with no cross-reactivity in the samples tested and performed with a limit of detection of 262 GE/mL. In summary, the assay had a turnaround time of fewer than 2 h and can easily be transferred to other automated PCR platforms, providing a basis for developing rapid assays for upcoming pandemics.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Korrespondenzautor
Schlagwörter Neumodx ; Pcr ; Automated Random-access Platforms ; Lab Development Test (ldt) ; Monkeypox (mpox) ; Rapid Testing
ISSN (print) / ISBN 0146-6615
e-ISSN 1096-9071
Zeitschrift Journal of Medical Virology
Quellenangaben Band: 95, Heft: 8, Seiten: , Artikelnummer: e29022 Supplement: ,
Verlag Wiley
Nichtpatentliteratur Publikationen
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Virology (VIRO)