Results of a SARS-CoV-2 virus genome detection external quality assessment round focusing on sensitivity of assays and pooling of samples.
PCR
SARS-CoV-2
external quality assessment
limit of detection
nucleic acid test (NAT)
pooling
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
26 07 2022
26 07 2022
Historique:
received:
19
03
2022
accepted:
16
05
2022
pubmed:
23
5
2022
medline:
22
6
2022
entrez:
22
5
2022
Statut:
epublish
Résumé
Results of earlier external quality assessment (EQA) rounds suggested remarkable differences in the sensitivity of SARS-CoV PCR assays. Although the test systems are intended to detect SARS-CoV-2 in individual samples, screening is often applied to sample pools to increase efficiency and decrease costs. However, it is unknown to what extent these tests actually meet the manufacturer's specifications for sensitivity and how they perform when testing sample pools. The sensitivity of assays in routine use was evaluated with a panel of positive samples in a round of a SARS-CoV-2 virus genome detection EQA scheme. The panel consisted of samples at or near the lower limit of detection ("weakly positive"). Laboratories that routinely test sample pools were asked to also analyze the pooled EQA samples according to their usual pool size and dilution method. All participants could detect a highly positive patient-derived sample (>10 The performance of most assays met or exceeded their specification on sensitivity. If assays are to be used to analyze sample pools, the sensitivity of the assay and the number of pooled samples must be balanced.
Identifiants
pubmed: 35599330
pii: cclm-2022-0263
doi: 10.1515/cclm-2022-0263
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1308-1312Informations de copyright
© 2022 Christoph Buchta et al., published by De Gruyter, Berlin/Boston.
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