APTIMA® transcription-mediated amplification assays for Chlamydia trachomatis and Neisseria gonorrhoeae

Expert Review of Molecular Diagnostics

Volumn 6, Issue 4, 2006, Pages 519-525

  Chernesky, Max A ^a   Jang, Dan E ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

Analytical sensitivity; APTIMA ; Automation; Chlamydia trachomatis; Clinical sensitivity; Inhibitor; Neisseria gonorrhoeae; Noninvasive specimen; Nucleic acid; Transcription mediated amplification

Indexed keywords

ARTICLE; ASSAY; BACTERIAL INFECTION; CHLAMYDIA TRACHOMATIS; DIAGNOSTIC TEST; DNA PROBE; HUMAN; LABORATORY APPARATUS, EQUIPMENT AND SUPPLIES; NEISSERIA GONORRHOEAE; NON INVASIVE PROCEDURE; NUCLEIC ACID AMPLIFICATION; SENSITIVITY AND SPECIFICITY; TRANSCRIPTION MEDIATED AMPLIFICATION ASSAY; TRANSCRIPTION REGULATION; URINALYSIS; UTERINE CERVIX CYTOLOGY; VAGINA SMEAR; ANALYTICAL EQUIPMENT; CHEMISTRY; CHLAMYDIASIS; FEMALE; GENETIC TRANSCRIPTION; GENETICS; GONORRHEA; INFECTION; MALE; REPRODUCIBILITY; REVIEW; SEXUALLY TRANSMITTED DISEASE; URINE;

NUCLEIC ACID;

CHLAMYDIA INFECTIONS; CHLAMYDIA TRACHOMATIS; FEMALE; GONORRHEA; HUMANS; INFECTION; MALE; NEISSERIA GONORRHOEAE; NUCLEIC ACID AMPLIFICATION TECHNIQUES; NUCLEIC ACIDS; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; SEXUALLY TRANSMITTED DISEASES; TRANSCRIPTION, GENETIC;

EID: 33746806316     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.6.4.519     Document Type: Article

References (20)

1. Stamm WE. Chlamydia trachomatis infections of the adult. In: Sexually Transmitted Diseases (3rd Edition). Holmes KK, Mårdh P-A, Sparling FP et al. (Eds), Mc-Graw Hill Companies, Inc., USA, 407-422 (1999). • Textbook chapter reviewing epidemiology, pathogenesis, diagnosis and treatment of Chlamydia trachomatis.
2. Hook EW III, Handsfield HH. Gonococcal infections in the adult. In: Sexually Transmitted Diseases (3rd Edition). Holmes KK, Mårdh P-A, Sparling FP et al. (Eds), Mc-Graw Hill Companies, Inc., USA, 451-466 (1999). • Textbook chapter reviewing epidemiology, pathogenesis, diagnosis and treatment of gonococcal infections.
3. Chernesky MA. Chlamydia trachomatis diagnostics. Sex. Trans. Infect. 78, 232-234 (2002). • Current review on chlamydial diagnostics.
4. Chernesky MA, Jang D, Lee H et al. Diagnosis of Chlamydia trachomatis infections in men and women by testing first-void urine by ligase chain reaction. J. Clin. Microbiol. 32, 2682-2685 (1994). •• First publication on the use of urine to diagnose C. trachomatis infections in men and women by LCx-amplified testing.
5. Hill CS. Molecular diagnostic testing for infectious diseases using TMA technology. Expert Rev. Mol. Diagn. 1(4), 445-455 (2001). •• Comprehensive review on transcription-mediated amplification technology and testing for infectious diseases.
6. Gaydos CA, Quinn TC, Willis D et al. 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 (2003). •• Report of multicenter clinical trial data on the performance of APTIMA Combo 2® (AC2) on female urine and cervical swabs.
7. Martin DH, Nsuami, M, Schachter J et al. Use of multiple nucleic acid amplification tests to define the infected-patient "Gold Standard" in clinical trials of new diagnostic tests for Chlamydia trachomatis infections. J. Clin. Microbiol. 42, 4749-4758 (2004). •• Multicenter clinical trial data on AC2 performance on male samples.
8. x assay but not in the APTIMA Combo 2 assay when testing for inhibitors. J. Clin. Microbiol. 41, 778-782 (2003). • First documentation of lack the of inhibitors in clinical samples for AC2 amplification using C. trachomatis spiking experiments.
9. Chernesky M, Jang D, Luinstra K et al. High analytical sensitivity and low rates of inhibition may contribute to detection of Chlamydia trachomatis in significantly more women by the APTIMA Combo 2 assay. J. Clin. Microbiol. 44, 400-405 (2006). •• Multisample study of women infected with C. trachomatis, which demonstrated major differences in analytical sensitivities and susceptibility to inhibitors for AC2, AMPLICOR® and ProbeTec™.
10. x assay, and direct fluorescent-antibody and culture assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J. Clin. Microbiol. 42, 3089-3093 (2004). •• Demonstrates the ability of alternate primer APTIMA CT (ACT) and APTIMA GC (AGC) to confirm AC2 results.
11. Østergaard L, Anderson B, Møller JK, Olesen F. Home sampling versus conventional swab sampling for screening of Chlamydia trachomatis in women: a cluster-randomized 1-year follow-up study. Clin. Infect. Dis. 31, 951-957 (2000). • One of a series of papers on home sampling for C. trachomatis.
12. Gaydos CA, Barnes M, Dwyer K et al. Use of an internet program to facilitate screening for Chlamydia trachomatis. Proc. American Society of Microbiology 105th General Meeting. GA, USA, C-342 (2005). • Review of internet use to screen susceptible persons for infections.
13. Chernesky MA, Martin DH, Hook EW et al. Ability of new APTIMA CT and APTIMA GC assays to detect Chlamydia trachomatis and Neisseria gonorrhoeae in male urine and urethral swabs. J. Clin. Microbiol. 43, 127-131 (2005). •• Multicenter trial report on the accuracy of testing male samples with the ACT and AGC assays.
14. Schachter J, Chernesky MA, Willis DE et al. Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections. Sex. Trans. Dis. 32, 725-728 (2005). •• Report of multicenter female study comparing ACT and AGC testing against AC2 and ProbeTec, which demonstrated the advantages of vaginal swab testing.
15. Chernesky MA, Hook EW III, Martin DH et al. Women find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis or Neisseria gonorrhoeae infections. Sex. Trans. Dis. 32, 729-733 (2005). • Demonstrates the ease of collection and preference for self-collection of vaginal swabs in a large, diverse group of women.
16. x and ProbeTec on female urines.
17. Bott M, Bixby T, Castillo M et al. APTIMA Combo 2 analytical performance with C. trachomatis and N. gonorrhoeae. In: Sexually Transmitted Infecitons. Kohl P, Jodl S (Eds), Monduzzi Editore SPA, Bologna, Italy, 55-60 (2001). • Documentation of analytical sensitivity of AC2 for C. trachomatis and Neisseria gonorrhoeae.
18. Ikeda-Dantsuji Y, Konomi I, Nagayama A. In vitro assessment of the APTIMA Combo 2 assay for the detection of Chlamydia trachomatis using highly purified elementary bodies. J. Med. Microbiol. 54, 357-360 (2005). • Analytical sensitivity of AC2 test for C. trachomatis.
19. Chernesky MA, Castrticiano S, Jang D, Smieja M. Use of flock swabs and a universal transport medium to enhance molecular detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J. Clin. Microbiol. 44, 1084-1086 (2006). • Compares analytical sensitivity of AC2, AMPLICOR and ProbeTec for C. trachomatis and N. gonorrhoeae. Demosntrates sensitivity enhancement by flocked swabs.
20. Schachter J, Hook EW, Martin DH et al. Confirming positive results of nucleic acid amplification tests (NAATs) for Chlamydia trachomatis: all NAATs are not created equal. J. Clin. Microbiol. 43, 1372-1373 (2005). •• Illustrates the dilemma of confirmatory testing of C. trachomatis positives by different kits, which have different clinical sensitivities.