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