Aptima Combo 2® Assay (for CT/NG)
Protect and improve the reproductive and sexual health of patients through accurate and early detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG).
Protecting Reproductive & Sexual Health
The dual target detection Aptima Combo 2 assay provides excellent diagnostic performance across a broad range of specimen types, from both patient and clinician collected samples.1 The assay targets rRNA for the enhanced detection of multiple targets.
Chlamydia trachomatis
23s rRNA target (dual)
Neisseria gonorrhoeae
16s rRNA target
Aptima® CT and Aptima® GC assays with different targets are also available for testing on the same sample.
Clarity & Confidence in Every Diagnosis
The CE-marked assay delivers reliable results from multiple specimen types, including male urine and self or clinician-collected vaginal swabs.1
Designed to Detect Future Variants
The probe region provides diagnostic protection against future genetic variants.1 Dual detection probes provide detection of all known variants of Chlamydia trachomatis, including the recently emerged Finnish variant (FI-nvCT).2
High Sensitivity & Specificity
This NAAT (Nucleic Acid Amplification Test) targets rRNA to ensure excellent assay sensitivity with proven assay performance. Provides an upfront biological advantage compared with assays that detect DNA, as there is up to 1,000-fold more rRNA than DNA per cell.3
Improve Workflow & Assay Consolidation
Benefit from efficient workflow, reduced hands-on time and sample volume scalability, by running assays on the fully automated Panther® System.4
Simplify & Scale the Future of Diagnostics
The Aptima Combo 2 Assay is part of the Hologic Molecular Scalable Solution, a portfolio combining a broad, high performing assay menu with high throughput automation. Designed to flexibly scale to meet your needs, from a single patient result to population level screening.
Proven Performance
Since the assay was launched in 2001, its performance has been characterised during clinical trials and thoroughly examined in over 80 peer reviewed scientific articles.
>95%
sensitivity in both symptomatic and asymptomatic infection5
23s rRNA target (dual)
Chlamydia trachomatis
16s rRNA target
Neisseria gonorrhoea
Aligned With UK National Guidelines
"The current Standard of care for all cases (Chlamydia), including medico-legal cases and extragenital infections is NAAT."
"A vulvo-vaginal sample is the specimen of choice for women… and can be taken by the patient or a healthcare worker."
"First Catch urine in men is reported to be as or more sensitive than urethral sampling. Urine samples are easy to collect, do not cause discomfort and thus are preferable to urethral swabs."6
One Sample, Multiple STI Results
Clinically relevant sample type options make the Aptima Combo 2 Assay easy to order as a standalone or in combination with other assays from the automated Hologic STI Solution. Browse relevant collection devices below.
Aptima® Multitest Swab Specimen Collection Kit
Collect samples from a variety of specimen sites. Detect up to 7 infections and disease states with just one vaginal swab. CT/NG testing made simple with vaginal (clinician & self collected), rectal and throat collection. Click to see sensitivity and specificity.
Aptima® Urine Specimen Collection Kit
Intended to be used for the collection and transport of male or female urine specimens. Click to see sensitivity and specificity performance.
Aptima® Unisex Swab Specimen Collection Kit
Used for the collection of female endocervical or male urethral swab specimens. Click to see sensitivity and specificity performance.
Protect Fertility With Accurate Testing
Chlamydia and gonorrhoea can have serious long-term consequences, including pelvic inflammatory disease (PID), ectopic pregnancy and infertility.7 Accurate testing and treatment are critical to protecting sexual and reproductive health.
In 2019, novel CT variants were discovered in Northern Europe. The updated version of the Aptima Combo 2 Assay includes dual (redundant) CT detection probes. They not only detect all known variants of CT, but also may provide some diagnostic protection against future variants within the AC2 probe region.2
Evidence. Insight. Collaboration.
Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.
Insights
- Aptima Combo 2 Assay. [package insert]. AW-19693-001 Rev. 001. Hologic, Inc., 2020.
- Unemo M, Hansen M, Hada R, et al. Sensitivity specificity, inclusivity and exclusivity of the updated Aptima Combo2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants. BMC Infect. Dis 2020;20:419.
- 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. 2006:44(2):400-405.
- Ratnam S, Jang D, Gilchrist J et.al. Workflow and Maintenance Characteristics of Five Automated Laboratory Instruments for the Diagnosis of Sexually Transmitted Infections. J. Clin. Microbiol. 2014;52(7):2299-2304.
- Fifer H, Saunders J, Soni S, et al. British Association for Sexual Health and HIV national guideline for the management of infection with Neisseria gonorrhoeae (2019). [Cited Nov 12]. Available from https://pcwhf.co.uk/wp-content/uploads/2019/03/gc-2019.pdf
- Nwokolo NC, Dragovic B, Patel S, et al. 2015 UK national guideline for the management of infection with Chlamydia trachomatis.Int J STD AIDS. 2016 Mar;27(4):251-67.
- Workowski KA, Bachman LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR Recomm Rep 2021;70.
Documents
Safety Data Sheets
Package Inserts
1434
2797
Hologic BV, Da Vincilaan 5, 1930 Zaventem, Belgium.
Notified Body number wherever applicable