The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.

The APTIMA COMBO 2 Assay virtually eliminates inhibition problems and cross-reactivity, offers multiplex detection and differentiation and also improves workflow and throughput. The testing solution is cost-effective by providing two results from one sample and also increases laboratory efficiency with single tube testing. Use of the assay provides clinicians and laboratorians with the appropriate tools to be able to significantly reduce the prevalence and incidence of CT and GC infections in sexually active individuals as well as prevent their serious and costly sequelae.

The sensitivity of the APTIMA COMBO 2 Assay has been shown to be superior to culture and direct specimen tests. The greater sensitivity of the test permits the use of specimens other than endocervical swabs for women and urethral swabs for men. It is the only assay with urine specimen sensitivity equivalent to swab specimen. Additionally, excellent sensitivity and specificity has been demonstrated with vaginal swabs and Cytyc ThinPrep liquid Pap specimens in the APTIMA COMBO 2 Assay. Hologic Gen-Probe also offers single analyte APTIMA assays for individual supplemental testing for CT and GC.

The APTIMA COMBO 2 assay was cleared for In Vitro Diagnostic Use by the FDA in 2001. The APTIMA CT and APTIMA GC assays were cleared for use by the FDA in 2005.  The Assays are CE marked for IVD use.

For additional availability in other countries please contact your local sales rep or distributor.

Performance Data

Comparison of APTIMA Combo 2, Amplicor and Probetec for the Diagnosis of C. trachomatis (CT) and N. gonorrhoeae (GC) in Surepath L-Pap Samples Chernesky; St. Joseph's Hospital, Hamilton, Canada, Poster 2009 ISSTDR

APTIMA transcription-mediated amplification assays for Chlamydia trachomatis and Neisseria gonorrhoeae Chernesky; McMaster University and St. Joseph's Healthcare, 2006 Future Drugs Ltd

Women Prefer Self-Collection of Vaginal Swabs Which are as Effective for the Diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae as Urine, Cervical Swabs and Clinician-Collected Vaginal Swabs Chernesky; St. Joseph's Hospital, Hamilton, Canada, Poster 2004 European Congress of Clinical Microbiology and Infectious Disease

Comparison of Analytical Sensitivity and Specificity of AC2, Roche Amplicor, and BD ProbeTec in Detecting Neisseria gonorrhoeae Ferrero; San Joaquin PH, Stockton, CA, Poster 2004 American Society of Microbiology Meeting

Detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in Co-infected patients Using the Hologic Gen-Probe APTIMA Combo 2 (AC2) Nucleic Acid Amplification Test (NAAT) Ferrero; San Joaquin PH, Stockton, CA, Poster 2004 International Congress on Infectious Disease

The TIGRIS DTS System Reduces Operator-Related Error during Nucleic Acid Amplication Testing Hook; University of Alabama at Birminham Medical Center, Poster 2004 American Society of Microbiology Meeting

Ergonomic Workflow Analysis of the APTIMA Combo 2 assay for Chlamydia trachomatis and Neisseria gonorrhoeae on the TIGRIS DTS System compared to Four Semi-automated Assay Systems Novak; Kaiser, North Hollywood, CA Anders; Ergonomic Engineering, Pelham, MA, Poster 2004 American Society of Microbiology Meeting

High Throughput Testing of the APTIMA Combo 2 Assay for Chlamydia trachomatis and Neisseria gonorrhoeae on the Fully automated TIGRIS DTS System Novak; Kaiser, North Hollywood, CA, Poster 2004 American Society of Microbiology Meeting

Ability of the APTIMA Combo 2 Assay to Detect Chlamydia trachomatis and Neisseria gonorrhoeae in Liquid PAP Samples Jang; St. Joseph's Hospital, Hamilton, Canada, Poster 2003 European Congress of Clinical Microbiology and Infectious Disease

Ergonomic Workflow Analysis of the APTIMA Combo 2 assay and ProbeTec Nucleic Acid amplification for Chlamydia trachomatis and Neisseria gonorrhoeae Novak; Kaiser, North Hollywood, CA, Anders; Ergonomic Engineering, Pelham, MA Poster 2003 American Society of Microbiology Meeting

Comparison of Hologic Gen-Probe APTIMA Combo 2 (AC2) Assay for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) with ProbeTec and LCx on urine and Swab specimens from Women Using a Rotating Standard Martin; Louisiana State University Medical Center, New Orleans, LA, Poster 2002 American Society of Microbiology Meeting

Comparison of Hologic Gen-Probe APTIMA Combo 2 Assay to BDProbeTec ET Assay for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Urine and Endocervical Swab Specimens from Females Fuller; Wishard Health Services, Indianapolis, IN, Poster 2002 American Society of Microbiology Meeting

Head-To-Head Study Comparing Performance of the AC2, Abbott LCx, BD ProbeTec, and Roche Amplicor Assays in Detecting Chlamydia trachomatis From First Catch Urine Ferrero; San Joaquin PH, Stockton, CA, Poster 2002 American Society of Microbiology Meeting

Analytical Sensitivity Comparison of Chlamydia trachomatis (CT) Nucleic Acid Amplification Assays Ferrero; San Joaquin PH, Stockton, CA, Poster 2002 European IUSTI