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Mpox infection investigation using multiplexed syndromic diagnostics: Evaluation of an AusDiagnostics multiplexed tandem PCR (MT-PCR) syndromic panel by M.J. Pond; J. Al-Mufti; P. Madona; M.A. Crone; K.G. Laing; R.S. Hale; D. Muir; P. Randell is a Medicine article available to read on EtoBox.

What is Mpox infection investigation using multiplexed syndromic diagnostics: Evaluation of an AusDiagnostics multiplexed tandem PCR (MT-PCR) syndromic panel about?

Background Detection of mpox virus during investigation of viral vesicular rash illness is required to identify mpox infection. Objectives This study evaluated the performance of a research-use-only (RUO) AusDiagnostics MT-PCR syndromic assay containing an mpox virus target. Methods The analytical specificity and limit of detection (LoD) of the AusDiagnostics MT-PCR mpox assay was verified using control material. Clinical performance was evaluated using anonymised residual nucleic acids extracted from swab specimens previously tested for mpox virus using a laboratory developed test (LDT). Residual nucleic acids were derived from consecutive sample panels collected during two periods in the 2022 mpox outbreak. Results The AusDiagnostics MT-PCR assay demonstrated an LoD of 35 input copies of mpox virus and correctly detected all relevant members of a specificity panel (n = 34). 175 residual nucleic acids were included in the study with a prevalence of mpox of 40.0% (95%CI 32.7–47.6). The AusDiagnostics MT-PCR mpox assay demonstrated an accuracy of 98.9% (95%CI 93.8–99.9), sensitivity of 94.2% (95%CI 85.2 – 98.1) and specificity of 100% (95%CI 95.6 -100), when compared to the LDT qPCR

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Author

M.J. Pond; J. Al-Mufti; P. Madona; M.A. Crone; K.G. Laing; R.S. Hale; D. Muir; P. Randell

Publisher

Elsevier BV

Published

2023

Language

EN

Field

Medicine (Health Sciences)