Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System.
BD MAX
COVID-19
Hologic Aptima
RT-qPCR
SARS-CoV-2
agreement
nucleic acid amplification test
Journal
Journal of clinical microbiology
ISSN: 1098-660X
Titre abrégé: J Clin Microbiol
Pays: United States
ID NLM: 7505564
Informations de publication
Date de publication:
18 11 2021
18 11 2021
Historique:
pubmed:
30
9
2021
medline:
24
11
2021
entrez:
29
9
2021
Statut:
ppublish
Résumé
Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two emergency use authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. The limits of detection (LOD) for the BD SARS-CoV-2 reagents for the BD MAX system (MAX SARS-CoV-2 assay), the bioMérieux BioFire respiratory panel 2.1 (BioFire SARS-CoV-2 assay), the Roche cobas SARS-CoV-2 assay (cobas SARS-CoV-2 assay), and the Hologic Aptima SARS-CoV-2 assay Panther (Aptima SARS-CoV-2 assay) NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with 7 target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a postmarket clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using the cobas and BioFire SARS-CoV-2 NAATs. In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/ml; 95% confidence interval [CI], 186 to 427) was comparable to the cobas SARS-CoV-2 assay (298 copies/ml; 95% CI, 225 to 509) and the BioFire SARS-CoV-2 assay (302 copies/ml; 95% CI, 219 to 565); the Aptima SARS-CoV-2 assay had an LOD of 612 copies/ml (95% CI, 474 to 918). The MAX SARS-CoV-2 assay had a PPA of 100% (95% CI, 97.3% to 100.0%) and an NPA of 96.7% (95% CI, 94.9% to 97.9%) compared to the Aptima SARS-CoV-2 assay. The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.
Identifiants
pubmed: 34586894
doi: 10.1128/JCM.01019-21
pmc: PMC8601249
doi:
Substances chimiques
Indicators and Reagents
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0101921Subventions
Organisme : BD Biosciences (Becton Dickenson Biosciences)
Références
J Hum Genet. 2020 Dec;65(12):1075-1082
pubmed: 32699345
Emerg Infect Dis. 2020 Jul;26(7):1470-1477
pubmed: 32255761
J Clin Microbiol. 2020 Aug 24;58(9):
pubmed: 32651238
N Engl J Med. 2020 Feb 20;382(8):727-733
pubmed: 31978945
Reprod Biomed Online. 2020 Sep;41(3):483-499
pubmed: 32651106
Cell. 2020 May 14;181(4):914-921.e10
pubmed: 32330414
Bull World Health Organ. 2020 Jul 1;98(7):495-504
pubmed: 32742035
Nat Microbiol. 2020 Oct;5(10):1299-1305
pubmed: 32651556
J Virol Methods. 2021 Aug;294:114182
pubmed: 33984397
J Virol Methods. 2020 Nov;285:113970
pubmed: 32920028
Ann Intern Med. 2020 Jun 2;172(11):726-734
pubmed: 32282894
J Clin Virol. 2020 Aug;129:104501
pubmed: 32619959
Radiology. 2015 Dec;277(3):826-32
pubmed: 26509226
Diagn Microbiol Infect Dis. 2021 Mar;99(3):115260
pubmed: 33340934
PCR Methods Appl. 1993 Dec;3(3):S18-29
pubmed: 8118393
J Clin Microbiol. 2020 Aug 24;58(9):
pubmed: 32571894
Diagn Microbiol Infect Dis. 2021 May;100(1):115334
pubmed: 33571862