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Validation of a new extraction-free real-time PCR test to detect MPOX virus.

Authors :
Lima, Amorce
Rowe, Laura
Silbert, Suzane
Source :
Diagnostic Microbiology & Infectious Disease. Jun2024, Vol. 109 Issue 2, pN.PAG-N.PAG. 1p.
Publication Year :
2024

Abstract

The monkeypox (Mpox) virus has raised significant concerns given its recent spread with an increasing number of confirmed cases worldwide. In this study, we evaluated the performance of a laboratory developed test (LDT) using BioGX Xfree hMPXV/OPXV reagents for the qualitative detection of non-variola Orthopoxviruses and Mpox virus DNA, in swabs from human pustular or vesicular rash specimens. Analytical and clinical testing analysis were carried out on two different platforms: the BD MAX™ System (BD Diagnostics) and the new pixl.16 Real-Time PCR Platform (BioGX), using a synthetic Mpox virus DNA (ATCC VR-3270SD) and residual clinical samples previously identified with an EUA approved Mpox real-time PCR assay. In the end, the Xfree hMPXV/OPXV LDT proved to be a sensitive, specific, and reproducible test for the detection of Mpox on both platforms evaluated with the pixl.16 having an advantage of a small footprint and providing faster TAT facilitated by an extraction-free workflow. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
07328893
Volume :
109
Issue :
2
Database :
Academic Search Index
Journal :
Diagnostic Microbiology & Infectious Disease
Publication Type :
Academic Journal
Accession number :
176864813
Full Text :
https://doi.org/10.1016/j.diagmicrobio.2024.116265