Interpret with caution: An evaluation of the commercial AusDiagnostics versus in-house developed assays for the detection of SARS-CoV-2 virus.
Adolescent
Adult
Aged
Aged, 80 and over
Betacoronavirus
/ isolation & purification
COVID-19
Child
Child, Preschool
Coronavirus Infections
/ diagnosis
Female
Humans
Infant
Infant, Newborn
Male
Middle Aged
Molecular Diagnostic Techniques
/ methods
Nasopharynx
/ virology
Pandemics
Pneumonia, Viral
/ diagnosis
SARS-CoV-2
Sensitivity and Specificity
Young Adult
Covid-19
NAT
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:
06 2020
06 2020
Historique:
received:
02
03
2020
revised:
13
04
2020
accepted:
14
04
2020
pubmed:
4
5
2020
medline:
3
6
2020
entrez:
4
5
2020
Statut:
ppublish
Résumé
There is limited data on the analytical performance of commercial nucleic acid tests (NATs) for laboratory confirmation of COVID-19 infection. Nasopharyngeal, combined nose and throat swabs, nasopharyngeal aspirates and sputum was collected from persons with suspected SARS-CoV-2 infection, serial dilutions of SARS-CoV-2 viral cultures and synthetic positive controls (gBlocks, Integrated DNA Technologies) were tested using i) AusDiagnostics assay (AusDiagnostics Pty Ltd); ii) in-house developed assays targeting the E and RdRp genes; iii) multiplex PCR assay targeting endemic respiratory viruses. Discrepant SARS-CoV-2 results were resolved by testing the N, ORF1b, ORF1ab and M genes. Of 52 clinical samples collected from 50 persons tested, respiratory viruses were detected in 22 samples (42 %), including SARS CoV-2 (n = 5), rhinovirus (n = 7), enterovirus (n = 5), influenza B (n = 4), hMPV (n = 5), influenza A (n = 2), PIV-2 (n = 1), RSV (n = 2), CoV-NL63 (n = 1) and CoV-229E (n = 1). SARS-CoV-2 was detected in four additional samples by the AusDiagnostics assay. Using the in-house assays as the "gold standard", the sensitivity, specificity, positive and negative predictive values of the AusDiagnostics assay was 100 %, 92.16 %, 55.56 % and 100 % respectively. The Ct values of the real-time in-house-developed PCR assay targeting the E gene was significantly lower than the corresponding RdRp gene assay when applied to clinical samples, viral culture and positive controls (mean 21.75 vs 28.1, p = 0.0031). The AusDiagnostics assay is not specific for the detection SARS-CoV-2. Any positive results should be confirmed using another NAT or sequencing. The case definition used to investigate persons with suspected COVID-19 infection is not specific.
Identifiants
pubmed: 32361322
pii: S1386-6532(20)30116-5
doi: 10.1016/j.jcv.2020.104374
pmc: PMC7195305
pii:
doi:
Types de publication
Comparative Study
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
104374Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
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