Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs.
Journal
The Journal of molecular diagnostics : JMD
ISSN: 1943-7811
Titre abrégé: J Mol Diagn
Pays: United States
ID NLM: 100893612
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
03
12
2019
revised:
26
02
2020
accepted:
10
03
2020
pubmed:
6
4
2020
medline:
31
7
2021
entrez:
6
4
2020
Statut:
ppublish
Résumé
Chlamydia trachomatis and Neisseria gonorrhoeae infections in the rectum and pharynx are important extragenital reservoirs of infection. Few assays approved by the US Food and Drug Administration are commercially available to diagnose pharyngeal or rectal infections. The current study reports on the analytical performance of the Abbott RealTime CT/NG assay, including the limit of detection, inclusivity, and analytical specificity for C. trachomatis and N. gonorrhoeae in rectal and pharyngeal specimens. The limit of detection was performed using known concentrations of organisms, elementary bodies per milliliter (EB/mL) for C. trachomatis and colony-forming units per milliliter (CFU/mL) for N. gonorrhoeae, in clinical rectal and pharyngeal swab matrices. Inclusivity was performed against 12 serovars of C. trachomatis and seven strains of N. gonorrhoeae. The analytical specificity was performed using 28 different bacteria and viruses. The limit of detection for C. trachomatis was 2.56 EB/mL in pharyngeal specimens and 12.8 EB/mL in rectal specimens. The limit of detection for N. gonorrhoeae was 0.0256 CFU/mL for both pharyngeal and rectal specimens. The inclusivity and analytical specificity were 100% for both rectal and pharyngeal specimens. These analytical performance data demonstrate that the Abbott CT/NG RealTime assay is an accurate, sensitive, and specific assay in rectal and pharyngeal specimens, supporting the potential of the assay for detection of rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections.
Identifiants
pubmed: 32247863
pii: S1525-1578(20)30074-X
doi: 10.1016/j.jmoldx.2020.03.004
pmc: PMC7295135
pii:
doi:
Types de publication
Evaluation Study
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
811-816Subventions
Organisme : NIMH NIH HHS
ID : T32 MH080634
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI104681
Pays : United States
Organisme : NIAID NIH HHS
ID : K24 AI093969
Pays : United States
Informations de copyright
Copyright © 2020 Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.
Références
J Clin Microbiol. 2016 Oct;54(10):2485-90
pubmed: 27413195
J Infect Dis. 2015 May 15;211(10):1628-45
pubmed: 25492913
PLoS One. 2015 Aug 11;10(8):e0134991
pubmed: 26262680
Sex Transm Infect. 2019 Aug;95(5):317-321
pubmed: 31097678
MMWR Recomm Rep. 2015 Jun 5;64(RR-03):1-137
pubmed: 26042815
Clin Infect Dis. 2019 Nov 17;:
pubmed: 31734695
Clin Microbiol Rev. 2014 Jul;27(3):587-613
pubmed: 24982323
J Infect Dis. 2019 Dec 16;:
pubmed: 31840181
J Clin Microbiol. 2019 Dec 23;58(1):
pubmed: 31694973
MMWR Recomm Rep. 2014 Mar 14;63(RR-02):1-19
pubmed: 24622331
J Clin Microbiol. 2011 Dec;49(12):4304-6
pubmed: 21956992
J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):537-43
pubmed: 19935075