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Aptima Combo 2 Assay for CT/NG

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) utilizes a unique combination for unparalleled technology with proven detection of these often asymptomatic pathogens that, when left untreated, can cause permanent reproductive health complications.

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 rRNA, the Aptima Combo 2 assay enhances the sensitivity of  amplification tests and virtually eliminates false negatives by removing amplification inhibitors.9

Excellent Sensitivity8

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

Individual Aptima CT and Aptima GC assays also available on the Tigris DTS system.

Features

Aptima Combo 2 assay 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-collected vaginal sample
  • Multitest Swab - Clinician or patient-collected vaginal sample
  • Unisex Swab - Female endocervical/male urethral
  • Urine - Female* or male
  • ThinPrep Pap Test Vial - Easily and conveniently add CT/NG to the Pap test

*Female urine sample type is not FDA cleared for the Panther system. 

Please check package insert for all approved sample types based on assay type.

Industry-leading Automation

  • Panther system
  • Tigris DTS system
Performance Data

Performance of the Panther System15

 
CT
NG
 
Sensitivity %
Specificity %
Sensitivity %
Specificity %
Multitest Swab (Patient- and Clinician- Collected Vaginal Sample)
97.2
98.5 97.7 99.6
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 %
Multitest Swab (Clinician-Collected Vaginal Sample)
96.6
98.5
98.5
99.6
Multitest Swab (Patient-Collected Vaginal Sample) 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
Male Urine
97.9
98.5
98.5
99.6
Regulatory

The Aptima Combo 2 assay for CT/NG, the Aptima CT assay and the Aptima GC assay 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.