Oh Joo Kweon1, Jee-Hye Choi1, Un Heung Song2, Ae Ja Park3. 1. Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea. 2. Department of Biomedical Laboratory Science, Shinhan University, Gyeonggi-do, Republic of Korea. 3. Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea. Electronic address: ajcp@unitel.co.kr.
Abstract
BACKGROUND: To prevent the recurrence of genitourinary infections and to reduce the risks of their complications, accurate and rapid diagnosis are required. STDetect® Chip is a DNA chip which allows for the simultaneous detection of 13 major genitourinary pathogens in a single vaginal swab or urine specimen. We evaluated the analytical performance of the STDetect® Chip for detecting target pathogens that commonly cause genitourinary infections. METHODS: The target pathogens of the STDetect® Chip are Chlamydia trachomatis, Candida albicans, Enterococcus faecalis, Gardnerella vaginalis, Mycoplasma hominis, Neisseria gonorrhoeae, Mycoplasma genitalium, Ureaplasma urealyticum, Staphylococcus aureus, Klebsiella pneumoniae, Trichomonas vaginalis, and Herpes simplex virus types 1 and 2. Performance of the STDetect® Chip for the detection of target pathogens was evaluated comparing with the result of direct sequencing and conventional multiplex PCR assay. And precision tests for STDetect® Chip were performed with quality control materials. RESULTS: The STDetect® Chip showed high sensitivities (95.1%-100%), specificities (93.4% to 100%), concordance rates (95.0%-100%), positive predictive values (69.8%-100%), and negative predictive values (93.1%-100%) in its identification of 13 target pathogens. The STDetect® Chip had a particularly excellent concordance rate (96.5%) for the 4 major pathogens, C. albicans, G. vaginalis, M. hominis, and U. urealyticum, compared with direct sequencing. Comparing to multiplex PCR assay, STDetect® Chip showed better sensitivity for detecting M. hominis (97.0% vs. 54.5%) and U. urealyticum (93.2% vs. 65.9%). In precision tests, coefficients of variations for signal intensities were ranged from 11.2% to 26.2%. CONCLUSION: The STDetect® Chip showed excellent analytical performance, and its result was in good agreement with that obtained by direct sequencing.
BACKGROUND: To prevent the recurrence of genitourinary infections and to reduce the risks of their complications, accurate and rapid diagnosis are required. STDetect® Chip is a DNA chip which allows for the simultaneous detection of 13 major genitourinary pathogens in a single vaginal swab or urine specimen. We evaluated the analytical performance of the STDetect® Chip for detecting target pathogens that commonly cause genitourinary infections. METHODS: The target pathogens of the STDetect® Chip are Chlamydia trachomatis, Candida albicans, Enterococcus faecalis, Gardnerella vaginalis, Mycoplasma hominis, Neisseria gonorrhoeae, Mycoplasma genitalium, Ureaplasma urealyticum, Staphylococcus aureus, Klebsiella pneumoniae, Trichomonas vaginalis, and Herpes simplex virus types 1 and 2. Performance of the STDetect® Chip for the detection of target pathogens was evaluated comparing with the result of direct sequencing and conventional multiplex PCR assay. And precision tests for STDetect® Chip were performed with quality control materials. RESULTS: The STDetect® Chip showed high sensitivities (95.1%-100%), specificities (93.4% to 100%), concordance rates (95.0%-100%), positive predictive values (69.8%-100%), and negative predictive values (93.1%-100%) in its identification of 13 target pathogens. The STDetect® Chip had a particularly excellent concordance rate (96.5%) for the 4 major pathogens, C. albicans, G. vaginalis, M. hominis, and U. urealyticum, compared with direct sequencing. Comparing to multiplex PCR assay, STDetect® Chip showed better sensitivity for detecting M. hominis (97.0% vs. 54.5%) and U. urealyticum (93.2% vs. 65.9%). In precision tests, coefficients of variations for signal intensities were ranged from 11.2% to 26.2%. CONCLUSION: The STDetect® Chip showed excellent analytical performance, and its result was in good agreement with that obtained by direct sequencing.