Clinical Usefulness of a DNA Microarray-based Assay for the Diagnosis of Sexually Transmitted Infections

ABSTRACT

BACKGROUND: Many molecular diagnostic methods have been developed to detect sexually transmitted infections (STI). The STDetect Chip (LabGenomics, Korea) which is a DNA microarray-based tool, newly developed for STI diagnosis in vitro, and the real-time PCR-based Anyplex STI-7 (Seegene, Korea) in clinical use were evaluated using ATCC DNA and clinical samples to determine the clinical usefulness of the STDetect Chip. METHODS: The two methods were compared for consistency, sensitivity, and specificity for 6 pathogens in 300 prospectively selected clinical samples. Analytical sensitivity for ATCC Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis and Trichomonas vaginalis DNA and the effect of mixing bacterial DNA were studied. RESULTS: The consistency of the two methods for clinical samples was superior at more than 0.92 kappa value. The sensitivity and specificity of the STDetect Chip compared with Anyplex STI-7 were 90.5-98.8%, and 95.6-99.6%, respectively. With similar analytical performance for ATCC DNA, the STDetect Chip detected 10(-5) ng/µL of N. gonorrhoeae, 10(-4) ng/µL of C. trachomatis, 10(-6) ng/µL of M. hominis, and 10(-3) ng/µL of T. vaginalis. For the mixture of three bacterial DNAs, less sensitive detection level was observed for T. vaginalis. CONCLUSIONS: The STDetect Chip showed good agreement with the Anyplex STI-7 test and it is considered clinically useful for detecting sexually transmitted pathogens.