Overview
Package Inserts
Protect fertility with accurate CT/NG testing.
STIs are on the rise. Chlamydia (CT) and gonorrhea (NG) can have serious long-term consequences including pelvic inflammatory disease (PID), ectopic pregnancy and infertility.1 Accurate testing and treatment are critical to protecting sexual and reproductive health. The Aptima Combo 2® assay delivers reliable results from multiple specimen types, including self and clinician-collected vaginal swabs with the Aptima® Multitest Swab — the preferred specimen type of the CDC for CT and NG testing.1,2
Universal Screening
CDC continues to recommend CT/NG screening for all sexually active women 15-24 years old but recognizes that young women may be hesitant to disclose sexual activity. Thus, CDC recommends that providers might consider an opt-out, or universal, screening approach for adolescent and young adult females.1
Universal Screening benefits the lab, healthcare systems, HCPs and patients:1,3-4
- Labs are reinforced as trusted partners to HCPs for STI testing and information.
- Healthcare systems will improve clinical outcomes and quality metrics.
- HCPs will have fewer uncomfortable conversations, identify and treat more infections, and improve quality metrics.
- Patients’ reproductive health/ fertility is preserved.
References:
1. Workowski, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR Recomm Rep 2021;70. 2. Aptima Combo 2 Assay (Panther system). US package insert 502466-IFU-PI. Hologic, Inc., 2021. 3. Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. Washington, DC: U.S. Department of Health and Human Services; 2020. 4. Owusu-Edusei K, et al. Cost- Effectiveness of Opt-Out Chlamydia Testing for High-Risk Young Women in the U.S. Am J Prev Med. 2016;51(2):216-24. doi.org/10.1016/j.amepre.2016.01.007
Overview
Package Inserts
Protect fertility with accurate CT/NG testing
STIs are on the rise. Chlamydia (CT) and gonorrhea (NG) can have serious long-term consequences including pelvic inflammatory disease (PID), ectopic pregnancy and infertility.1 Accurate testing and treatment are critical to protecting sexual and reproductive health. The CE-marked Aptima Combo 2 assay delivers reliable results from multiple specimen types, including self and clinician-collected vaginal swabs with the Aptima Multitest Swab — a preferred specimen type for CT and NG testing.1,2
Improved accuracy through design
An updated version of the Aptima Combo 2 assay is CE-marked and available for use. In 2019, novel Chlamydia trachomatis (CT) variants were discovered in northern Europe.3-8 Variants are a natural biological occurrence, and microorganisms that cause sexually transmitted infections (STIs) have been known to evolve over time. The updated version of the Aptima Combo 2 assay includes dual (redundant) CT detection probes, which not only detect all known variants of CT, but also may provide some diagnostic protection against future variants within the AC2 probe region. Additional testing flexibility is available with the Aptima CT and Aptima GC assays, which employ alternative target regions than the AC2 assay, providing more confidence in diagnosis when required.9,10
The updated version of the Aptima Combo 2 assay may not be available in all countries. Contact your local Hologic representative for more information on availability in your region.
Safety Data Sheets
References:
1. Workowski, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR Recomm Rep 2021;70. 2. Aptima Combo 2 Assay. UK package insert. AW-19693-001. Hologic, Inc., 2020. 3. U.S. Food & Drug Administration. 510(k) Premarket Notification Database: Gen-Probe. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 8, 2019. 4. Rantakokko-Jalava et al. Chlamydia trachomatis samples testing falsely negative in the Aptima Combo 2 test in Finland, 2019. Euro Surveill. 2019;24(22):pii=1900298. 5. Unemo M, et al. Letter to the editor: Chlamydia trachomatis samples testing falsely negative in the Aptima Combo 2 test in Finland, 2019. Euro Surveill. 2019;24(24):pii=1900354. 6. Unemo M, et al. Finnish new variant of Chlamydia trachomatis escaping detection in the Aptima Combo 2 assay also present in Örebro County, Sweden, May 2019. Euro Surveill. 2019;24(26):pii=1900370. 7. Hokynar K, et al. The Finnish New Variant of Chlamydia trachomatis with a Single Nucleotide Polymorphism in the 23S rRNA Target Escapes Detection by the Aptima Combo 2 Test. Microorganisms 2019, 7(8), 227. 8. Roberts DJ, et al. Prevalence of new variants of Chlamydia trachomatis escaping detection by the Aptima Combo 2 assay, England, June to August 2019. Euro Surveill. 2019;24(38):pii=1900557. 9. Aptima CT Assay. OUS package insert. 502184EN-IFU-PI. Hologic, Inc., 2019 10. Aptima GC Assay. OUS package insert. 502185EN-IFU-PI. Hologic, Inc., 2019.
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