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Evaluation of CDC-recommended approaches for confirmatory testing of positive Neisseria gonorrhoeae nucleic acid amplification test results.
J Clin Microbiol. 2008 May; 46(5):1614-9.JC

Abstract

We evaluated three of the CDC approaches for confirming Neisseria gonorrhoeae (gonococcus [GC])-positive nucleic acid amplification test (NAAT) results: (i) repeating the original test on the original specimen, (ii) testing the original specimen with a different test, and (iii) performing a different test on a duplicate specimen collected at the same visit. For the first approach, clinical specimens were initially tested by Aptima Combo 2 (AC2) (Gen-Probe Inc., San Diego, CA), ProbeTec (strand displacement amplification [SDA]) (Becton Dickinson Co., Sparks, MD), and Amplicor (PCR) (Roche Molecular Systems, Branchburg, NJ). The original GC-positive specimens were then retested by the same NAAT for confirmation. For the second approach, specimens initially positive by AC2, SDA, or PCR were retested by different NAATs (SDA, PCR, AC2, and Aptima Neisseria gonorrhoeae assay [AGC]; Gen-Probe Inc.). For the third approach, duplicate urethral swabs and first-catch urine (FCU) samples from men and duplicate cervical swabs and FCU samples from women were each tested by SDA, AC2, and AGC in parallel. We found that 89 to 96% of samples positive by SDA, PCR, and AC2 were confirmed by repeat testing and that 85 to 98% of SDA, PCR, and AC2 results were confirmed by using different NAATs on the original specimen. For FCU samples from men, any NAAT can be used for confirmation. However, for all other specimen types, some NAATs cannot be used to confirm positive results from other NAATs. Thus, a single repeat test appears to be a reliable method for confirmation, but by doing more extensive testing, an additional 5% were confirmed. With >90% of all GC-positive NAATs being confirmed, our results show that confirmatory testing is not warranted for these genital specimens.

Authors+Show Affiliations

Department of Laboratory Medicine, University of California, San Francisco, California 94110, USA. Jeanne.Moncada@ucsf.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

18322062

Citation

Moncada, Jeanne, et al. "Evaluation of CDC-recommended Approaches for Confirmatory Testing of Positive Neisseria Gonorrhoeae Nucleic Acid Amplification Test Results." Journal of Clinical Microbiology, vol. 46, no. 5, 2008, pp. 1614-9.
Moncada J, Donegan E, Schachter J. Evaluation of CDC-recommended approaches for confirmatory testing of positive Neisseria gonorrhoeae nucleic acid amplification test results. J Clin Microbiol. 2008;46(5):1614-9.
Moncada, J., Donegan, E., & Schachter, J. (2008). Evaluation of CDC-recommended approaches for confirmatory testing of positive Neisseria gonorrhoeae nucleic acid amplification test results. Journal of Clinical Microbiology, 46(5), 1614-9. https://doi.org/10.1128/JCM.02301-07
Moncada J, Donegan E, Schachter J. Evaluation of CDC-recommended Approaches for Confirmatory Testing of Positive Neisseria Gonorrhoeae Nucleic Acid Amplification Test Results. J Clin Microbiol. 2008;46(5):1614-9. PubMed PMID: 18322062.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of CDC-recommended approaches for confirmatory testing of positive Neisseria gonorrhoeae nucleic acid amplification test results. AU - Moncada,Jeanne, AU - Donegan,Elizabeth, AU - Schachter,Julius, Y1 - 2008/03/05/ PY - 2008/3/7/pubmed PY - 2008/6/6/medline PY - 2008/3/7/entrez SP - 1614 EP - 9 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 46 IS - 5 N2 - We evaluated three of the CDC approaches for confirming Neisseria gonorrhoeae (gonococcus [GC])-positive nucleic acid amplification test (NAAT) results: (i) repeating the original test on the original specimen, (ii) testing the original specimen with a different test, and (iii) performing a different test on a duplicate specimen collected at the same visit. For the first approach, clinical specimens were initially tested by Aptima Combo 2 (AC2) (Gen-Probe Inc., San Diego, CA), ProbeTec (strand displacement amplification [SDA]) (Becton Dickinson Co., Sparks, MD), and Amplicor (PCR) (Roche Molecular Systems, Branchburg, NJ). The original GC-positive specimens were then retested by the same NAAT for confirmation. For the second approach, specimens initially positive by AC2, SDA, or PCR were retested by different NAATs (SDA, PCR, AC2, and Aptima Neisseria gonorrhoeae assay [AGC]; Gen-Probe Inc.). For the third approach, duplicate urethral swabs and first-catch urine (FCU) samples from men and duplicate cervical swabs and FCU samples from women were each tested by SDA, AC2, and AGC in parallel. We found that 89 to 96% of samples positive by SDA, PCR, and AC2 were confirmed by repeat testing and that 85 to 98% of SDA, PCR, and AC2 results were confirmed by using different NAATs on the original specimen. For FCU samples from men, any NAAT can be used for confirmation. However, for all other specimen types, some NAATs cannot be used to confirm positive results from other NAATs. Thus, a single repeat test appears to be a reliable method for confirmation, but by doing more extensive testing, an additional 5% were confirmed. With >90% of all GC-positive NAATs being confirmed, our results show that confirmatory testing is not warranted for these genital specimens. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/18322062/Evaluation_of_CDC_recommended_approaches_for_confirmatory_testing_of_positive_Neisseria_gonorrhoeae_nucleic_acid_amplification_test_results_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=18322062 DB - PRIME DP - Unbound Medicine ER -