Nucleic Acid Amplification Testing for Neisseria gonorrhoeae

Gerbase, 1998, Global prevalence and incidence estimates of selected curable STDs, Sex Transm Inf, 74, S12 Centers for Disease Control and Prevention, 2003 Biro, 1995, Gonococcal and chlamydial genitourinary infections in symptomatic and asymptomatic adolescent women, Clin Pediatr (Phila), 34, 419, 10.1177/000992289503400804 Tapsall, 2001 Brunham, 1993, Bacterial antigenic variation, host immune response, and pathogen-host coevolution, Infect Immun, 61, 2273, 10.1128/IAI.61.6.2273-2276.1993 O'Rourke, 1993, Genetic structure of Neisseria gonorrhoeae populations: a non-clonal pathogen, J Gen Microbiol, 139, 2603, 10.1099/00221287-139-11-2603 Kline, 2003, Recombination, repair and replication in the pathogenic Neisseria: the 3 R's of molecular genetics of two human-specific bacterial pathogens, Mol Microbiol, 50, 3, 10.1046/j.1365-2958.2003.03679.x Peeling, 1999, Molecular techniques for HIV and STDs: implications for research and disease control in the new millenium, 219 Miller, 1999, Impact of improved diagnosis and treatment on prevalence of gonorrhoea and chlamydial infection in remote aboriginal communities on Anangu Pitjantjatjara Lands, Med J Aust, 170, 429, 10.5694/j.1326-5377.1999.tb127819.x Johnson, 2002, Screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections: 2002, MMWR Recomm Rep, 18, 1 Koumans, 1998, Laboratory testing for Neisseria gonorrhoeae by recently introduced nonculture tests: a performance review with clinical and public health considerations, Clin Infect Dis, 27, 1171, 10.1086/514994 Thomason, 1989, Effectiveness of Gonozyme for detection of gonorrhea in low-risk pregnant and gynecologic populations, Sex Transm Dis, 16, 28, 10.1097/00007435-198901000-00006 Chapin-Robertson, 1992, Evaluation of the Gen-Probe PACE II assay for the direct detection of Neisseria gonorrhoeae in endocervical specimens, Diagn Microbiol Infect Dis, 15, 645, 10.1016/0732-8893(92)90065-2 Modarress, 1999, Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in swab specimens by the Hybrid Capture II and PACE 2 nucleic acid probe tests, Sex Transm Dis, 26, 303, 10.1097/00007435-199905000-00012 Beltrami, 1998, Evaluation of the Gen-Probe PACE 2 assay for the detection of asymptomatic Chlamydia trachomatis and Neisseria gonorrhoeae infections in male arrestees, Sex Transm Dis, 25, 501, 10.1097/00007435-199811000-00001 Schachter, 1999, Ability of the digene hybrid capture II test to identify Chlamydia trachomatis and Neisseria gonorrhoeae in cervical specimens, J Clin Microbiol, 37, 3668, 10.1128/JCM.37.11.3668-3671.1999 Centers for Disease Control and Prevention, 2002, Notice to readers: recall of LCx Neisseria gonorrhoeae assay and implications for laboratory testing for N. gonorrhoeae and Chlamydia trachomatis, MMWR Morb Mortal Wkly Rep, 51, 709 Bassiri, 1997, Multiplex AMPLICOR PCR screening for Chlamydia trachomatis and Neisseria gonorrhoeae in women attending non-sexually transmitted disease clinics: The European Chlamydia Epidemiology Group, J Clin Microbiol, 35, 2556, 10.1128/JCM.35.10.2556-2560.1997 Caldwell, 1971, Sensitivity and reproducibility of Thayer-Martin culture medium in diagnosing gonorrhea in women, Am J Obstet Gynecol, 109, 463, 10.1016/0002-9378(71)90346-2 Schmale, 1969, Observations on the culture diagnosis of gonorrhea in women, JAMA, 210, 312, 10.1001/jama.210.2.312 Garrow, 2002, The diagnosis of chlamydia, gonorrhoea, and trichomonas infections by self obtained low vaginal swabs, in remote northern Australian clinical practice, Sex Transm Infect, 78, 278, 10.1136/sti.78.4.278 Mahony, 1998, Urine specimens from pregnant and non-pregnant women inhibitory to amplification of Chlamydia trachomatis nucleic acid by PCR, ligase chain reaction, and transcription-mediated amplification: identification of urinary substances associated with inhibition and removal of inhibitory activity, J Clin Microbiol, 36, 3122, 10.1128/JCM.36.11.3122-3126.1998 Chan, 2000, Performance characteristics of the Becton Dickinson ProbeTec System for direct detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male and female urine specimens in comparison with the Roche Cobas System, Arch Pathol Lab Med, 124, 1649, 10.5858/2000-124-1649-PCOTBD Toye, 1988, Inhibition of PCR in genital and urine specimens submitted for Chlamydia trachomatis testing, J Clin Microbiol, 36, 2356, 10.1128/JCM.36.8.2356-2358.1998 Verkooyen, 1996, Detection of PCR inhibitors in cervical specimens by using the Amplicor Chlamydia trachomatis assay, J Clin Microbiol, 34, 3072, 10.1128/JCM.34.12.3072-3074.1996 Hoorfar, 2003, Making internal amplification control mandatory for diagnostic PCR, J Clin Microbiol, 41, 5835, 10.1128/JCM.41.12.5835.2003 Gaydos, 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, 10.1128/JCM.41.1.304-309.2003 Hamilton, 2002, High frequency of competitive inhibition in the Roche Cobas AMPLICOR multiplex PCR for Chlamydia trachomatis and Neisseria gonorrhoeae, J Clin Microbiol, 40, 4393, 10.1128/JCM.40.11.4393.2002 Kacena, 1998, Pooling of urine samples for screening for Neisseria gonorrhoeae by ligase chain reaction: accuracy and application, J Clin Microbiol, 36, 3624, 10.1128/JCM.36.12.3624-3628.1998 Kissin, 2002, Epidemiology and natural history of ligase chain reaction detected chlamydial and gonococcal infections, Sex Transm Infect, 78, 208, 10.1136/sti.78.3.208 Currie, 2004, Pooling of clinical specimens prior to testing for Chlamydia trachomatis by PCR is accurate and cost saving, J Clin Microbiol, 42, 4866, 10.1128/JCM.42.10.4866-4867.2004 Kacena, 1998, Pooling urine samples for ligase chain reaction screening for genital Chlamydia trachomatis infection in asymptomatic women, J Clin Microbiol, 36, 481, 10.1128/JCM.36.2.481-485.1998 Krepel, 1999, The impact on accuracy and cost of ligase chain reaction testing by pooling urine specimens for the diagnosis of Chlamydia trachomatis infections, Sex Transm Dis, 26, 504, 10.1097/00007435-199910000-00004 Morre, 2000, Pooling of urine specimens for detection of asymptomatic Chlamydia trachomatis infections by PCR in a low-prevalence population: cost-saving strategy for epidemiological studies and screening programs, J Clin Microbiol, 38, 1679, 10.1128/JCM.38.4.1679-1680.2000 Peeling, 1998, Pooling of urine specimens for PCR testing: a cost saving strategy for Chlamydia trachomatis control programmes, Sex Transm Infect, 74, 66, 10.1136/sti.74.1.66 Bang, 2003, Comparison of the Becton Dickinson strand displacement amplification and Cobas Amplicor Roche PCR for the detection of Chlamydia trachomatis: pooling versus individual tests, Clin Microbiol Infect, 9, 1020, 10.1046/j.1469-0691.2003.00738.x Burkardt, 2000, Standardization and quality control of PCR analyses, Clin Chem Lab Med, 38, 87, 10.1515/CCLM.2000.014 Fenton, 2003, Ciprofloxacin resistance in Neisseria gonorrhoeae in England and Wales in 2002, Lancet, 361, 1867, 10.1016/S0140-6736(03)13489-7 Ameyama, 2002, Mosaic-like structure of penicillin-binding protein 2 gene (penA) in clinical isolates of Neisseria gonorrhoeae with reduced susceptibility to cefixime, Antimicrob Agents Chemother, 46, 3744, 10.1128/AAC.46.12.3744-3749.2002 Li, 2002, Rapid detection of quinolone resistance-associated gyrA mutations in Neisseria gonorrhoeae with a LightCycler, J Infect Chemother, 8, 145, 10.1007/s101560200025 World Health Organization, 1997 Tapsall, 2004, Antimicrobial testing and applications in the pathogenic Neisseria, 175 Young, 2003, Evaluation of ligase chain reaction for the non-cultural detection of rectal and pharyngeal gonorrhoea in men who have sex with men, Sex Transm Infect, 79, 484, 10.1136/sti.79.6.484 Tapsall J: How the biology of Neisseria gonorrhoeae impinges upon laboratory contributions to control of gonococcal disease [Abstract]. Program and Abstracts of the 2004 National Conference of the Australian Society for Microbiology International, 2004 Bachmann, 2002, Duration of persistence of gonococcal DNA detected by ligase chain reaction in men and women following recommended therapy for uncomplicated gonorrhea, J Clin Microbiol, 40, 3596, 10.1128/JCM.40.10.3596-3601.2002 Ison, 1992, Concordance of auxotype/serovar classes of Neisseria gonorrhoeae between sexual contacts, Epidemiol Infect, 109, 265, 10.1017/S0950268800050214 Sarafian, 1989, Molecular epidemiology of gonorrhea, Clin Microbiol Rev, 2, S49, 10.1128/CMR.2.Suppl.S49 Wang, 1977, Immunologic classification of Neisseria gonorrhoeae with micro-immunofluorescence, J Immunol, 119, 795, 10.4049/jimmunol.119.3.795 Palmer, 2003, Evaluation of the specificities of five DNA amplification methods for the detection of Neisseria gonorrhoeae, J Clin Microbiol, 41, 835, 10.1128/JCM.41.2.835-837.2003 Bruisten, 2004, Multicenter validation of the cppB gene as a PCR target for detection of Neisseria gonorrhoeae, J Clin Microbiol, 42, 4332, 10.1128/JCM.42.9.4332-4334.2004 Tabrizi, 2004, Evaluation of real time polymerase chain reaction assays for confirmation of Neisseria gonorrhoeae in clinical samples tested positive in the Roche Cobas Amplicor assay, Sex Transm Infect, 80, 68, 10.1136/sti.2003.006239 Lum, 2005, A cluster of gonococcal infections positive on culture but with negative cppB gene based nucleic acid amplification assays, Sex Transm Infect, 81, 400, 10.1136/sti.2004.013805 Tapsall J, Limnios A, Carter I, Lum G, Freeman K, Sloots T: A cluster of culture-positive, but PCR false negative infections with Neisseria gonorrhoeae [abstract]. Program and Abstracts of the 15th Biennial Congress of the International Society for Sexually Transmitted Diseases Research (ISSTDR), 27–30 July 2003; Ottawa, ON, Canada. 2003, 0129 Ching, 1995, Ligase chain reaction for detection of Neisseria gonorrhoeae in urogenital swabs, J Clin Microbiol, 33, 3111, 10.1128/JCM.33.12.3111-3114.1995 Leslie, 2003, An assessment of the Roche Amplicor Chlamydia trachomatis/Neisseria gonorrhoeae multiplex PCR assay in routine diagnostic use on a variety of specimen types, Commun Dis Intell, 27, 373 Van Der Pol, 2000, Multicenter evaluation of the AMPLICOR and automated COBAS AMPLICOR CT/NG tests for detection of Chlamydia trachomatis, J Clin Microbiol, 38, 1105, 10.1128/JCM.38.3.1105-1112.2000 Van Dyck, 2001, Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by enzyme immunoassay, culture, and three nucleic acid amplification tests, J Clin Microbiol, 39, 1751, 10.1128/JCM.39.5.1751-1756.2001 Feavers, 1998, A gonococcal porA pseudogene: implications for understanding the evolution and pathogenicity of Neisseria gonorrhoeae, Mol Microbiol, 30, 647, 10.1046/j.1365-2958.1998.01101.x Vazquez, 1993, Ecological separation and genetic isolation of Neisseria gonorrhoeae and Neisseria meningitidis, Curr Biol, 3, 567, 10.1016/0960-9822(93)90001-5 Frosch, 1992, Transformation-mediated exchange of virulence determinants by co-cultivation of pathogenic Neisseriae, FEMS Microbiol Lett, 79, 345, 10.1111/j.1574-6968.1992.tb14062.x Gibbs, 1996, Genome plasticity in Neisseria gonorrhoeae, FEMS Microbiol Lett, 145, 173, 10.1111/j.1574-6968.1996.tb08574.x Linz, 2000, Frequent interspecific genetic exchange between commensal Neisseriae and Neisseria meningitidis, Mol Microbiol, 36, 1049, 10.1046/j.1365-2958.2000.01932.x Smith, 1999, Networks and groups within the genus Neisseria: analysis of argF, recA, rho, and 16S rRNA sequences from human Neisseria species, Mol Biol Evol, 16, 773, 10.1093/oxfordjournals.molbev.a026162 Farrell, 1999, Evaluation of AMPLICOR Neisseria gonorrhoeae PCR using cppB nested PCR and 16S rRNA PCR, J Clin Microbiol, 37, 386, 10.1128/JCM.37.2.386-390.1999 Whiley DM, Sloots TP: A new Neisseria gonorrhoeae PCR assay [abstract]. Roche LightCycler User Group Meeting 2–4 November 2004; 2004:9.30 Mt. Wellington, New Zealand Young, 1988, Immunological diagnosis of gonococcal infection, vol 23, 77 Knapp, 1995, Neisseria and Branhamella, 324 Hammerschlag, 2003, Appropriate use of nonculture tests for the detection of sexually transmitted diseases in children and adolescents, Semin Pediatr Infect Dis, 14, 54, 10.1053/spid.2003.127218 Centers for Disease Control and Prevention, 2002, Sexually transmitted diseases treatment guidelines, 2002, MMWR Recomm Rep, 51, 67 Katz, 2004, False-positive gonorrhea test results with a nucleic acid amplification test: the impact of low prevalence on positive predictive value, Clin Infect Dis, 38, 814, 10.1086/381895 Klausner, 2004, The NAAT is out of the bag, Clin Infect Dis, 38, 820, 10.1086/381897 Diemert, 2002, Confirmation by 16S rRNA PCR of the COBAS AMPLICOR CT/NG test for diagnosis of Neisseria gonorrhoeae infection in a low-prevalence population, J Clin Microbiol, 40, 4056, 10.1128/JCM.40.11.4056-4059.2002 Green, 1998, Evaluation of bias in diagnostic-test sensitivity and specificity estimates computed by discrepant analysis, J Clin Microbiol, 36, 375, 10.1128/JCM.36.2.375-381.1998 Hadgu, 2000, Discrepant analysis is an inappropriate and unscientific method, J Clin Microbiol, 38, 4301, 10.1128/JCM.38.11.4301-4302.2000 Martin, 2000, Multicenter evaluation of AMPLICOR and automated COBAS AMPLICOR CT/NG tests for Neisseria gonorrhoeae, J Clin Microbiol, 38, 3544, 10.1128/JCM.38.10.3544-3549.2000 Moncada, 2004, The effect of urine testing in evaluations of the sensitivity of the Gen-Probe Aptima Combo 2 assay on endocervical swabs for Chlamydia trachomatis and Neisseria gonorrhoeae: the infected patient standard reduces sensitivity of single site evaluation, Sex Transm Dis, 31, 273, 10.1097/01.OLQ.0000124611.73009.D5 Turner, 1995, Comparison of three methods for culture confirmation of Neisseria gonorrhoeae strains currently circulating in the UK, J Clin Pathol, 48, 919, 10.1136/jcp.48.10.919 Page-Shafer, 2002, Increased sensitivity of DNA amplification testing for the detection of pharyngeal gonorrhea in men who have sex with men, Clin Infect Dis, 34, 173, 10.1086/338236 Stary, 1997, Comparison of ligase chain reaction and culture for detection of Neisseria gonorrhoeae in genital and extragenital specimens, J Clin Microbiol, 35, 239, 10.1128/JCM.35.1.239-242.1997 Whiley, 2005, A real-time PCR assay for the detection of Neisseria gonorrhoeae in genital and extragenital specimens, Diagn Microbiol Infect Dis, 52, 1, 10.1016/j.diagmicrobio.2004.12.011 Schwarcz, 1995, Temporal trends in human immunodeficiency virus seroprevalence and sexual behavior at the San Francisco municipal sexually transmitted disease clinic, 1989–1992, Am J Epidemiol, 142, 314, 10.1093/oxfordjournals.aje.a117637 Centers for Disease Control and Prevention, 1999, Increases in unsafe sex and rectal gonorrhea among men who have sex with men: San Francisco, 1994-1997, MMWR Morb Mortal Wkly Rep, 48, 45 Hutt, 1986, Epidemiology and treatment of oropharyngeal gonorrhea, Ann Intern Med, 104, 655, 10.7326/0003-4819-104-5-655 Jebakumar, 1995, Value of screening for oro-pharyngeal Chlamydia trachomatis infection, J Clin Pathol, 48, 658, 10.1136/jcp.48.7.658 Lafferty, 1997, Sexually transmitted diseases in men who have sex with men: acquisition of gonorrhea and nongonococcal urethritis by fellatio and implications for STD/HIV prevention, Sex Transm Dis, 24, 272, 10.1097/00007435-199705000-00007 Tice, 1981, Pharyngeal gonorrhea, JAMA, 246, 2717, 10.1001/jama.246.23.2717 Wiesner, 1973, Clinical spectrum of pharyngeal gonococcal infection, N Engl J Med, 288, 181, 10.1056/NEJM197301252880404 Farrell, 2001, Urinary screening for Neisseria gonorrhoeae in asymptomatic individuals from Queensland, Australia: an evaluation using three nucleic acid amplification methods, Pathology, 33, 204, 10.1080/00313020125013 van Doornum, 2001, Comparison between the LCx Probe system and the COBAS AMPLICOR system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in patients attending a clinic for treatment of sexually transmitted diseases in Amsterdam, The Netherlands, J Clin Microbiol, 39, 829, 10.1128/JCM.39.3.829-835.2001 Whiley, 2002, A real-time PCR assay for the detection of Neisseria gonorrhoeae by LightCycler, Diagn Microbiol Infect Dis, 42, 85, 10.1016/S0732-8893(01)00326-1 Whiley, 2004, A new confirmatory Neisseria gonorrhoeae real-time PCR assay targeting the porA pseudogene, Eur J Clin Microbiol Infect Dis, 23, 705, 10.1007/s10096-004-1170-0 Unemo M, Norlen O, Fredlund H: The porA pseudogene of Neisseria gonorrhoeae: genetic polymorphism and inactivating mutations. Program and Abstracts of the 14th International Pathogenic Neisseria Conference (IPNC), 5–10 September 2004; Milwaukee, WI, 2004, 318 Koenig, 2004, Direct comparison of the BD ProbeTec ET system with in-house LightCycler PCR assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae from clinical specimens, J Clin Microbiol, 42, 5751, 10.1128/JCM.42.12.5751-5756.2004 Braverman, 2002, Use of ligase chain reaction for laboratory identification of Chlamydia trachomatis and Neisseria gonorrhoeae in adolescent women, J Pediatr Adolesc Gynecol, 15, 37, 10.1016/S1083-3188(01)00137-1 Carroll, 1998, Evaluation of the Abbott LCx ligase chain reaction assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine and genital swab specimens from a sexually transmitted disease clinic population, J Clin Microbiol, 36, 1630, 10.1128/JCM.36.6.1630-1633.1998 Kehl, 1998, Evaluation of the Abbott LCx assay for detection of Neisseria gonorrhoeae in endocervical swab specimens from females, J Clin Microbiol, 36, 3549, 10.1128/JCM.36.12.3549-3551.1998 Smith, 1995, Evaluation of ligase chain reaction for use with urine for identification of Neisseria gonorrhoeae in females attending a sexually transmitted disease clinic, J Clin Microbiol, 33, 455, 10.1128/JCM.33.2.455-457.1995 Xu, 1998, Detection of Neisseria gonorrhoeae infection by ligase chain reaction testing of urine among adolescent women with and without Chlamydia trachomatis infection, Sex Transm Dis, 25, 533, 10.1097/00007435-199811000-00007 Golden, 2004, Positive predictive value of Gen-Probe APTIMA Combo 2 testing for Neisseria gonorrhoeae in a population of women with low prevalence of N. gonorrhoeae infection, Clin Infect Dis, 39, 1387, 10.1086/424880 Boyadzhyan, 2004, Comparison of the APTIMA CT and GC assays with the APTIMA combo 2 assay, the Abbott LCx assay, and direct fluorescent-antibody and culture assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae, J Clin Microbiol, 42, 3089, 10.1128/JCM.42.7.3089-3093.2004 Chaudhry, 2002, Detection of Neisseria gonorrhoeae by PCR using orf1 gene as target, Sex Transm Infect, 78, 72, 10.1136/sti.78.1.72 Liebling, 1994, Identification of Neisseria gonorrhoeae in synovial fluid using the polymerase chain reaction, Arthritis Rheum, 37, 702, 10.1002/art.1780370514 Tabrizi, 2005, Evaluation of opa-based real-time PCR for detection of Neisseria gonorrhoeae, Sex Transm Dis, 32, 199, 10.1097/01.olq.0000154495.24519.bf Livengood, 2001, Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens, J Clin Microbiol, 39, 2928, 10.1128/JCM.39.8.2928-2932.2001 Little, 1999, Strand displacement amplification and homogeneous real-time detection incorporated in a second-generation DNA probe system, BDProbeTecET, Clin Chem, 45, 777, 10.1093/clinchem/45.6.777