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Aptima Combo 2® assay (for CT/NG)

Accurate STI testing and treatment is critical to preserving the well-being of patients around the world. Chlamydia and gonorrhea are proven to have serious long-term consequences including pelvic inflammatory disease (PID), infertility and ectopic pregnancy.1,2 In 1994, Hologic pioneered the field of molecular diagnostics with DNA probe tests for chlamydia and gonorrhea testing, later followed by the first CE-marked NAAT duplex: the Aptima Combo 2 assay.

Overview

An updated version of the Aptima Combo 2 assay is now 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.

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.
 

References

1. Centers for Disease Control and Prevention. Chlamydia – CDC Fact Sheet (Detailed). https://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm. Updated October 17, 2016. Accessed January 8, 2019. 2. CDC. Gonorrhea – CDC Fact Sheet (Detailed). https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm. Updated October 28, 2016. Accessed January 8, 2019. 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.