Aptima® Neisseria gonorrhoeae Assay

Protect and improve the reproductive and sexual health of patients through accurate and early detection of Neisseria gonorrhoeae (NG).

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    Overview

    Documents

    Training

    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

    Technician walking in front of Panther Systems in a lab setting.

    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

    Gloved hand holding vial rack in a lab setting

    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.

    Man and woman walking outside and holding hands

    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

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    A Vision for Women-centric Care

    A Vision for Women-centric Care

      1. Aptima Neisseria gonorrhoeae Assay [Package Insert] AW-22785 Rev. 001. Hologic Inc., 2023 
      2. Aptima Combo 2 Assay. [package insert]. AW-19693-001 Rev. 001. Hologic, Inc., 2020
      3. Panther / Panther Fusion Operators Manual AW-26055-001 Rev. 001 Hologic, Inc., 2022
      4. 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.
      5. 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
      6. 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
      7. Workowski KA, Bachman LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR Recomm Rep 2021;70

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