Aptima Combo 2 for CT/NG assay

At Hologic we are dedicated to protecting the reproductive health of women through early, accurate detection of sexually transmitted infections (STIs). The Aptima Combo 2 assay for chlamydia trachomatis (CT) and neisseria gonorrhoeae (NG) offers a unique combination of unparalleled technology delivering the most sensitive test available designed to provide the most accurate diagnosis of infection.

About

Chlamydia and gonorrhea are the most commonly reported notifiable sexually transmitted bacterial infections.1 In the United States there are over 3 million new cases annually and worldwide the World Health Organization estimates the annual incidence of chlamydia to be 105.7 million and 106.1 million for gonorrhea.2,3 The Centers for Disease Control and Prevention (CDC) estimates that only 38% of sexually active young women are screened annually for chlamydia in the United States and that up to 75% of CT infected women are asymptomatic contributing to as many as 30% of CT infections progressing to PID which has been shown to cause permanent damage to a woman's reproductive system including infertility, chronic pelvic pain and ectopic pregnancy4,5,6.

Studies have shown that the Aptima Combo 2 assay for chlamydia trachomatis (CT) and neisseria gonorrhoeae (NG) is clinically more sensitive to culture and non-amplified test methods and to be the most sensitive nucleic acid amplification test available.7,8 By targeting rRNAAptima Combo 2 enhances the sensitivity of  amplification tests and virtually eliminates false negatives by removing amplificationinhibitors.9

Excellent Sensitivity8

Aptima Combo 2 for CT/NG is the leading choice of laboratories with a proven record of performance and quality.10,11

Individual Aptima CT and Aptima NG screening assays also available.

Features

Aptima Combo 2 for CT/NG provides:

Targeted Detection of rRNA

  • Biologically more abundant per cell - 10,000 fold more rRNA compared to DNA12
  • Removes potential amplification inhibitors13,14
  • Eliminates the need for an internal control
  • Allows multiple sample types to be run simultaneously with zero pre-processing

Confidence in Testing All Specimen Types

  • Vaginal swab - Clinician or patient-collect
  • Unisex swab - Female endocervical/male urethral
  • Urine - Female or male
  • The ThinPrep Pap test vial - Easily and conveniently add CT/NG to the Pap test

Industry-leading Automation

  • Panther system
  • Tigris DTS system
Performance Data

Performance of the Panther System15

 
CT
NG
 
Sensitivity %
Specificity %
Sensitivity %
Specificity %
Patient and Clinician Collected Vaginal Swab
96.6
 96.8 96.0 99.2
Endocervical Swab
97.2
99.3
100
99.8
ThinPrep Liquid Cytology
98.2
100
100
100
Male Urethral Swab
100
99.1
100
100
Male Urine
95.2
99.8
98.7
99.7

 

Performance of the Tigris DTS System7

 
CT
NG
 
Sensitivity %
Specificity %
Sensitivity %
Specificity %
Clinician-collected Vaginal Swab
96.6
98.5
98.5
99.6
Patient-collected Vaginal Swab 98.4 96.8 100 99.5
Endocervical Swab
94.2
97.6
99.2
98.7
ThinPrep Liquid Cytology
96.7
99.2
92.3
99.8
Male Urethral Swab
95.9
97.5
99.1
97.8
Mail Urine
97.9
98.5
98.5
99.6
Regulatory

The Aptima Combo 2 for CT/NG, Aptima CT and Aptima GC assays are FDA-cleared for in vitro diagnostic use. 

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

References
  1. CDC, Recommendations for the Laboratory-Based Detection of Chlamydia trachomatisand Neisseria gonorrhoeae-2014MMWR 2014; 63.
  2. Satterwhite CL, et at. Sex Transm Dis. 2013; CDC Fact Sheet 2013
  3. WHO, Global incidence and prevalence of selected curable sexually transmitted infections - 2008
  4. CDC. 2012 National STD Prevention Conference. 2012.
  5. National Committee for Quality Assurance. 2012.
  6. Thomas A. Farley, M.D., M.P.H., Preventive Medicine, 2003.
  7. Aptima Combo 2 Assay for DTS and Tigris DTS Systems Package Insert. San Diego, CA: Gen-Probe Incorporated, 2012.
  8. M. Chernesky, D. Jang, J. Gilchrist, T. Hatchette, A. Poirier, J.F. Flandin, M. Smieja and S. Ratnam. Head-to-Head Comparison of Second Generation Nucleic Acid Amplification Tests for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae on Urine Samples from Female Subjects and Self-Collected Vaginal Swabs. J.Clin. Microbiol. 2014;52(7): 2305.
  9. M. Chernesky, D. Jang. K. Luinstra, 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. ClinMicrobiol. 2006;44(2): 400-405.
  10. Piper Jaffrey Investment Research, Sixth Annual Molecular Diagnostics Update, June 2011.
  11. Sannes & Associates, Inc. CT and GC Testing Market Report, January 2011.
  12. J.L. Yang, J. Schachter, J. Moncada, D. Habte, M. Zerihun, J.I. House, Z. Zhou, K.C. Hong, K. Maxey, B.D. Gaynor and T. Lietman. Comparison of an rRNA-based DNA-based nucleic acid amplification test for the detection of Chlamydia trachomatis in trachoma. Br. J. Ophthalmol. 2007;91:293-295.
  13. S. Chong, D. Jang, X. Song, J. Mahony, A. Petrocj. P. Barriga, and M. Chernesky. Specimen Processing and Concentration of Chlamydia trachomatis added can Influence False-Negative Rates in the LCx Assay but not in the Aptima Combo 2 Assay when Testing for Inhibitors. J. Clin. Microbiol. 2003; 41(2): 778-782.
  14. M. Chernesky, D. Jang, K. Luinstra, et al. 2006. 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. Microbiology 44(2): 400-405.
  15. Aptima Combo 2 Assay for Panther System Package Insert. San Diego, CA: Gen-Probe Incorporated, 2013