Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Adamson, PC; Pandori, MW; Doernberg, SB; Komarow, L; Sund, Z; Tran, TTT; Jensen, D; Tsalik, EL; Deal, CD; Chambers, HF; Fowler, VG; Evans, SR; Patel, R; Klausner, JD; Antibacterial Resistance Leadership Group,

Published Date

  • June 2020

Published In

Volume / Issue

  • 22 / 6

Start / End Page

  • 811 - 816

PubMed ID

  • 32247863

Pubmed Central ID

  • PMC7295135

Electronic International Standard Serial Number (EISSN)

  • 1943-7811

Digital Object Identifier (DOI)

  • 10.1016/j.jmoldx.2020.03.004

Language

  • eng

Conference Location

  • United States