Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay.
Adult
Betacoronavirus
/ genetics
COVID-19
COVID-19 Testing
Clinical Laboratory Techniques
/ methods
Coronavirus Infections
/ diagnosis
Female
Humans
Male
Middle Aged
Multiplex Polymerase Chain Reaction
/ methods
Nasopharynx
/ virology
Oropharynx
/ virology
Pandemics
Pneumonia, Viral
/ diagnosis
Reproducibility of Results
SARS-CoV-2
Sensitivity and Specificity
COVID-19
Coronavirus
Diagnosis
MT-PCR
SARS-CoV-2
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
12
05
2020
revised:
15
05
2020
accepted:
16
05
2020
pubmed:
28
5
2020
medline:
7
7
2020
entrez:
28
5
2020
Statut:
ppublish
Résumé
In the context of the pandemic, the rapid emergency use authorisation of diagnostic assays for SARS-CoV-2 has meant there are few peer-reviewed published studies of clinical performance of commercial assays. To evaluate the clinical performance of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2. We reviewed the results following implementation of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, and compared with an in-house RT-PCR assay at our State Reference Laboratory. Initial validation using AusDiagnostics coronavirus multiplex tandem PCR assay including SARS-CoV-2 demonstrated good concordance with the State Reference Laboratory. After implementing the AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, we tested 7839 samples. 127 samples in which SARS-CoV-2 was detected using the AusDiagnostics assay were referred for testing at the State Reference Laboratory, with concordant results in 118/127 (92.9%) of samples. After resolution of discrepancies, 125/127 (98.4%) of AusDiagnostics results were determined to be true positive results. Out of 7839 samples tested for SARS-CoV-2 during this period, only 2 tests (0.02%) were indeterminate results. The AusDiagnostics respiratory MT-PCR assay is a reliable assay for detection of SARS-CoV-2.
Sections du résumé
BACKGROUND
In the context of the pandemic, the rapid emergency use authorisation of diagnostic assays for SARS-CoV-2 has meant there are few peer-reviewed published studies of clinical performance of commercial assays.
AIMS
To evaluate the clinical performance of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2.
METHODS
We reviewed the results following implementation of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, and compared with an in-house RT-PCR assay at our State Reference Laboratory.
RESULTS
Initial validation using AusDiagnostics coronavirus multiplex tandem PCR assay including SARS-CoV-2 demonstrated good concordance with the State Reference Laboratory. After implementing the AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, we tested 7839 samples. 127 samples in which SARS-CoV-2 was detected using the AusDiagnostics assay were referred for testing at the State Reference Laboratory, with concordant results in 118/127 (92.9%) of samples. After resolution of discrepancies, 125/127 (98.4%) of AusDiagnostics results were determined to be true positive results. Out of 7839 samples tested for SARS-CoV-2 during this period, only 2 tests (0.02%) were indeterminate results.
CONCLUSION
The AusDiagnostics respiratory MT-PCR assay is a reliable assay for detection of SARS-CoV-2.
Identifiants
pubmed: 32460173
pii: S1386-6532(20)30190-6
doi: 10.1016/j.jcv.2020.104448
pmc: PMC7236671
pii:
doi:
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104448Informations de copyright
Crown Copyright © 2020. Published by Elsevier B.V. All rights reserved.
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