Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay

Journal of Clinical Microbiology

Volumn 49, Issue 4, 2011, Pages 1294-1300

  Cheng, Annie ^a   Qian, Qinfang ^a   Kirby, James E ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

16S RNA GENE; ACCURACY; ARTICLE; ASSAY; BACTERIUM DETECTION; CHLAMYDIA TRACHOMATIS; COBAS AMPLICOR CHLAMYDIA TRACHOMATIS NEISSERIA GONORRHOEAE ASSAY; CONTROLLED STUDY; CROSS REACTION; DILUTION; FEMALE; GENE; GENE TARGETING; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; NEISSERIA GONORRHOEAE; NONHUMAN; PORA PSEUDOGENE; PRIORITY JOURNAL; REAL TIME POLYMERASE CHAIN REACTION; REALTIME CHLAMYDIA TRACHOMATIS NEISSERIA GONORRHOEAE ASSAY; SENSITIVITY AND SPECIFICITY; URINALYSIS;

AUTOMATION; BACTERIOLOGICAL TECHNIQUES; CERVIX UTERI; CHLAMYDIA INFECTIONS; CHLAMYDIA TRACHOMATIS; FEMALE; GONORRHEA; HUMANS; MALE; MOLECULAR DIAGNOSTIC TECHNIQUES; NEISSERIA GONORRHOEAE; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY; URETHRA; URINE;

CHLAMYDIA TRACHOMATIS; NEISSERIA GONORRHOEAE;

EID: 79953856384     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.02595-10     Document Type: Article

References (24)

1. Abbot Molecular, Inc. July 2008. Abbott RealTime CT/NG, in vitro test, ref. 8L07, 51-608201/R1, package insert. Abbott Molecular, Inc., Des Plaines, IL.
2. Blackhawk Biosystems, Inc. September 2006. AmpliTrol CT/GC, package insert. Blackhawk Biosystems, Inc., San Ramon, CA.
3. Boel, C. H., C. M. van Herk, P. J. Berretty, G. H. Onland, and A. J. van den Brule. 2005. Evaluation of conventional and real-time PCR assays using two targets for confirmation of results of the COBAS AMPLICOR Chlamydia trachomatis/Neisseria gonorrhoeae test for detection of Neisseria gonorrhoeae in clinical samples. J. Clin. Microbiol. 43:2231-2235. (Pubitemid 40656232)
4. CLSI. 2008. User protocol for evaluation of qualitative test performance; approved guideline, 2nd ed. CLSI document EP12-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
5. Feavers, I. M., and M. C. Maiden. 1998. A gonococcal porA pseudogene: Implications for understanding the evolution and pathogenicity of Neisseria gonorrhoeae. Mol. Microbiol. 30:647-656. (Pubitemid 28497939)
6. Gaydos, C. A., et al. 2010. Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J. Clin. Microbiol. 48:3236-3243.
7. Gaydos, C. A., et al. 2003. Performance of the APTIMA Combo 2 assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in female urine and endocervical swab specimens. J. Clin. Microbiol. 41:304-309. (Pubitemid 36098592)
8. Levett, P. N., et al. 2008. Evaluation of three automated nucleic acid amplification systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in first-void urine specimens. J. Clin. Microbiol. 46:2109-2111. (Pubitemid 351831856)
9. Marshall, R., et al. 2007. Characteristics of the m2000 automated sample preparation and multiplex real-time PCR system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J. Clin. Microbiol. 45:747-751. (Pubitemid 46427687)
10. Martin, D. H., et al. 2000. Multicenter evaluation of AMPLICOR and automated COBAS AMPLICOR CT/NG tests for Neisseria gonorrhoeae. J. Clin. Microbiol. 38:3544-3549.
11. McAdam, A. J. 2000. Discrepant analysis: How can we test a test? J. Clin. Microbiol. 38:2027-2029. (Pubitemid 30414310)
12. Miyada, C. G., and T. L. Born. 1991. A DNA sequence for the discrimination of Neisseria gonorrhoeae from other Neisseria species. Mol. Cell. Probes 5:327-335.
13. Morre, S. A., et al. 1998. Monitoring of Chlamydia trachomatis infections after antibiotic treatment using RNA detection by nucleic acid sequence based amplification. Mol. Pathol. 51:149-154. (Pubitemid 28375018)
14. Palmer, H. M., H. Mallinson, R. L. Wood, and A. J. Herring. 2003. Evaluation of the specificities of five DNA amplification methods for the detection of Neisseria gonorrhoeae. J. Clin. Microbiol. 41:835-837. (Pubitemid 36184209)
15. Pickett, M. A., J. S. Everson, P. J. Pead, and I. N. Clarke. 2005. The plasmids of Chlamydia trachomatis and Chlamydophila pneumoniae (N16): Accurate determination of copy number and the paradoxical effect of plasmid-curing agents. Microbiology 151:893-903. (Pubitemid 40425023)
16. Shain, E. B., and J. M. Clemens. 2008. A new method for robust quantitative and qualitative analysis of real-time PCR. Nucleic Acids Res. 36:e91.
17. Unemo, M., O. Norlen, and H. Fredlund. 2005. The porA pseudogene of Neisseria gonorrhoeae-low level of genetic polymorphism and a few, mainly identical, inactivating mutations. APMIS 113:410-419. (Pubitemid 40961721)
18. U.S. Preventive Services Task Force. 2007. Screening for chlamydial infection: U.S. Preventive Services Task Force recommendation statement. Ann. Intern. Med. 147:128-134.
19. Van Der Pol, B., et al. 2001. Enhancing the specificity of the COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae by retesting specimens with equivocal results. J. Clin. Microbiol. 39:3092-3098. (Pubitemid 32830299)
20. Whiley, D. M., et al. 2006. Evidence that the gonococcal porA pseudogene is present in a broad range of Neisseria gonorrhoeae strains; suitability as a diagnostic target. Pathology 38:445-448. (Pubitemid 44477595)
21. Whiley, D. M., et al. 2004. A new confirmatory Neisseria gonorrhoeae realtime PCR assay targeting the porA pseudogene. Eur. J. Clin. Microbiol. Infect. Dis. 23:705-710. (Pubitemid 39304326)
22. Whiley, D. M., J. W. Tapsall, and T. P. Sloots. 2006. Nucleic acid amplification testing for Neisseria gonorrhoeae: An ongoing challenge. J. Mol. Diagn. 8:3-15. (Pubitemid 43257429)
23. Workowski, K. A., and S. M. Berman. 2006. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recommend. Rep. 55(RR-11):1-94.
24. Workowski, K. A., and S. M. Berman. 2010. Sexually transmitted diseases treatment guidelines, 2010. MMWR Recommend. Rep. 59(RR-12):1-110.