Aptima® Neisseria gonorrhoeae Assay
Protect and improve the reproductive and sexual health of patients through accurate and early detection of Neisseria gonorrhoeae (NG).
Protecting Reproductive & Sexual Health
The single target Aptima Neisseria gonorrhoeae assay provides excellent diagnostic performance across a broad range of specimen types, from both patient and clinician collected samples. This assay adds additional testing flexibility by using an alternative target region than the Aptima Combo 2® assay (for CT/NG), providing more confidence in diagnosis.1,2
Clarity & Confidence in Every Diagnosis
The CE-marked assay delivers reliable results from multiple specimen types, including self and clinician-collected vaginal swabs, a preferred specimen for NG testing.1,3
Confidence in Diagnosis
The alternate target Aptima NG assay can be used for reflex testing on reactive Aptima Combo 2 samples when additional analysis is required.3
High Sensitivity & Specificity
A molecular NAAT (Nucleic Acid Amplification Test) that 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.4
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.5
Simplify & Scale the Future of Diagnostics
The Aptima NG 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
Alternate target testing for confidence in Neisseria gonorrhoea results.1
16sRNA target
Neisseria gonorrhoeae (NG)
Proven sensitivity
in both symptomatic and asymptomatic patients
No cross-reactions
when tested against a panel of organisms isolated from the urogenital tract
Aligned With UK National Guidelines
“NAATs are more sensitive than culture, particularly for oropharyngeal and rectal sites. NAATs show high sensitivity (>95%) in both symptomatic and asymptomatic infection.” 6
“It is recommended that laboratories confirm any reactive test with an alternative molecular target if the positive predictive value of the initial test for the population tested is less than 90%.” 6
One Sample, Multiple STI Results
Clinically relevant sample type options make the Aptima NG 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. NG testing made simple with vaginal clinician & self collected samples. Click to see sensitivity & 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 & specificity performance.
Aptima® Unisex Swab Specimen Collection Kit
Collect female endocervical or male urethral swab specimens. Click to see sensitivity & specificity performance.
Protect Fertility With Accurate Testing
Gonorrhoea (NG) 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.
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 Neisseria gonorrhoeae Assay [Package Insert] AW-22785 Rev. 001. Hologic Inc., 2023
- Aptima Combo 2 Assay. [package insert]. AW-19693-001 Rev. 001. Hologic, Inc., 2020
- Panther / Panther Fusion Operators Manual AW-26055-001 Rev. 001 Hologic, Inc., 2022
- 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
- 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