cobas® liat CT/NG nucleic acid test

The cobas liat CT/NG nucleic acid test is an automated, qualitative in vitro diagnostic test using real-time PCR to directly detect Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid in male urine and vaginal swabs. It is intended as an aid in diagnosing urogenital infections in both symptomatic and asymptomatic individuals.

The device uses real-time PCR amplification with automated sample preparation and detection via different reporter dyes for target and control (compared to the predicate's TaqMan technology with fluorescence resonance energy transfer). Both use cycle threshold analysis for results. The assay targets cryptic plasmid and 23S rRNA for CT, and pivNG and NGR9 for NG, with an internal control included in both devices.

Not stated in this summary.

Substantial equivalence is based on: (1) identical intended use—both detect CT and NG in male urine and vaginal swabs for urogenital infection diagnosis in symptomatic and asymptomatic patients; (2) same amplification technology (real-time PCR) and sample preparation (automated); (3) identical analyte targets and control strategy; (4) comparable analytical performance—LoDs of 0.085–0.784 EB/mL for CT and 0.200–0.500 CFU/mL for NG in representative serovars/strains; (5) clinical performance meeting or exceeding predicate standards with ≥97% sensitivity/PPA and ≥99.8% specificity/NPA for both analytes across specimen types; and (6) reproducibility across sites, lots, operators, and instruments. The primary technological difference—use of different reporter dyes instead of TaqMan probes—does not alter the fundamental performance or safety profile.