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We have developed a new research assay that combines sequence-specific sample preparation and isothermal amplification for the detection ofChlamydia trachomatis andNeisseria gonorrhoeae infections. The assay targets both theomp gene and the cryptic plasmid ofC. trachomatis and the multicopyopa gene ofN. gonorrhoeae , which are amplified and detected in a single reaction. We evaluated the ability of the assay to detectC. trachomatis andN. gonorrhoeae infections in first-catch urine, swab, and liquid-based cytology samples. Total agreement between the new assay and APTIMA Combo 2 varied between 95.3% and 100%, depending on the sample type and target detected. Total agreement between the new assay and BD ProbeTec varied between 96.7% and 100%, depending on the sample type and target detected. The assay has a simple work flow, and endpoint results can be achieved in 3 h, including sample preparation. The assay described here was evaluated for research use and was compared to commercially available assays.

journal of clinical microbiology

Evaluation of Chlamydia trachomatis and Neisseria gonorrhoeae Detection in Urine, Endocervical, and Vaginal Specimens by a Multiplexed Isothermal Thermophilic Helicase-Dependent Amplification (tHDA) Assay