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

Publication ,  Journal Article
Adamson, PC; Pandori, MW; Doernberg, SB; Komarow, L; Sund, Z; Tran, TTT; Jensen, D; Tsalik, EL; Deal, CD; Chambers, HF; Fowler, VG; Evans, SR ...
Published in: J Mol Diagn
June 2020

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.

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Published In

J Mol Diagn

DOI

EISSN

1943-7811

Publication Date

June 2020

Volume

22

Issue

6

Start / End Page

811 / 816

Location

United States

Related Subject Headings

  • Sensitivity and Specificity
  • Rectum
  • Real-Time Polymerase Chain Reaction
  • Pharynx
  • Pathology
  • Neisseria gonorrhoeae
  • Male
  • Limit of Detection
  • Humans
  • Gonorrhea
 

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Adamson, P. C., Pandori, M. W., Doernberg, S. B., Komarow, L., Sund, Z., Tran, T. T. T., … Antibacterial Resistance Leadership Group. (2020). Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs. J Mol Diagn, 22(6), 811–816. https://doi.org/10.1016/j.jmoldx.2020.03.004
Adamson, Paul C., Mark W. Pandori, Sarah B. Doernberg, Lauren Komarow, Zoe Sund, Thuy Tien T. Tran, David Jensen, et al. “Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs.J Mol Diagn 22, no. 6 (June 2020): 811–16. https://doi.org/10.1016/j.jmoldx.2020.03.004.
Adamson PC, Pandori MW, Doernberg SB, Komarow L, Sund Z, Tran TTT, et al. Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs. J Mol Diagn. 2020 Jun;22(6):811–6.
Adamson, Paul C., et al. “Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs.J Mol Diagn, vol. 22, no. 6, June 2020, pp. 811–16. Pubmed, doi:10.1016/j.jmoldx.2020.03.004.
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. Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs. J Mol Diagn. 2020 Jun;22(6):811–816.
Journal cover image

Published In

J Mol Diagn

DOI

EISSN

1943-7811

Publication Date

June 2020

Volume

22

Issue

6

Start / End Page

811 / 816

Location

United States

Related Subject Headings

  • Sensitivity and Specificity
  • Rectum
  • Real-Time Polymerase Chain Reaction
  • Pharynx
  • Pathology
  • Neisseria gonorrhoeae
  • Male
  • Limit of Detection
  • Humans
  • Gonorrhea