Evaluation of a fully closed real time PCR platform for the detection of SARS-CoV-2 in nasopharyngeal swabs: a pilot study.
COVID-19
PCR
infection control
Journal
Journal of clinical pathology
ISSN: 1472-4146
Titre abrégé: J Clin Pathol
Pays: England
ID NLM: 0376601
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
received:
01
03
2021
revised:
21
03
2021
accepted:
24
03
2021
pubmed:
11
4
2021
medline:
22
7
2022
entrez:
10
4
2021
Statut:
ppublish
Résumé
To date, reverse transcriptase PCR (RT-PCR) on nasopharyngeal swabs is the 'gold standard' approach for the diagnosis of COVID-19. The need to develop easy to use, rapid, robust and with minimal hands-on time approaches are warranted. In this setting, the Idylla SARS-CoV-2 Test may be a valuable option. The aim of our study is to evaluate the analytical and clinical performance of this assay on previously tested SARS-CoV-2 people by conventional RT-PCR based approach in different settings, including initial diagnosis and clinical follow-up. To evaluate the sensitivity and specificity of the Idylla SARS-CoV-2 Test, we retrieved 55 nasopharyngeal swabs, previously analysed by a fully validated assay, from symptomatic patients or from people who have been in close contact with COVID-19 positive cases. Discordant or high discrepant cases were further analysed by a third technique. In addition, a second subset of 14 nasopharyngeal swab samples with uncertain results (cycle threshold between 37 and 40), by using the fully validated assay, from patients with viral infection beyond day 21, were retrieved. Overall, Idylla showed a sensitivity of 93.9% and a specificity of 100.0%. In addition, in the additional 14 nasopharyngeal swab samples, only five (35.7%) featured a positive result by the Idylla SARS-CoV-2 Test. We demonstrated that the Idylla SARS-CoV-2 Test may represent a valid, fast, highly sensitive and specific RT-PCR test for the identification of SARS-CoV-2 infection.
Identifiants
pubmed: 33837109
pii: jclinpath-2021-207516
doi: 10.1136/jclinpath-2021-207516
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
551-554Informations de copyright
© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: UM has received personal fees (as consultant and/or speaker bureau) from Boehringer Ingelheim, Roche, MSD, Amgen, Thermo Fisher Scientifics, Diaceutics, GSK, Merck and AstraZeneca, unrelated to the current work. GT reports personal fees (as speaker bureau or advisor) from Roche, MSD, Pfizer and Bayer, unrelated to the current work.