title: Performance evaluation of a DNA chip assay in the identification of major genitourinary pathogens.
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%.
  
  
  CONCLUSIONS
  The STDetect® Chip showed excellent analytical performance, and its result was in good agreement with that obtained by direct sequencing.
authors.affiliation: Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
authors.forename: Oh Joo
authors.initials: OJ
authors.lastname: Kweon
authors.affiliation: Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jee-Hye
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Department of Biomedical Laboratory Science, Shinhan University, Gyeonggi-do, Republic of Korea.
authors.forename: Un Heung
authors.initials: UH
authors.lastname: Song
authors.affiliation: Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea. Electronic address: ajcp@unitel.co.kr.
authors.forename: Ae Ja
authors.initials: AJ
authors.lastname: Park
mesh_terms: D001424:Bacterial Infections / Q000175:diagnosis / Q000382:microbiology; D005260:Female; D006801:Humans; D008297:Male; D008828:Microbiological Techniques / Q000379:methods*; D009181:Mycoses / Q000175:diagnosis / Q000382:microbiology; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods*; D011247:Pregnancy; D011528:Protozoan Infections / Q000175:diagnosis / Q000469:parasitology; D060737:Reproductive Tract Infections / Q000175:diagnosis*; D012680:Sensitivity and Specificity; D014552:Urinary Tract Infections / Q000175:diagnosis*; D014556:Urine / Q000382:microbiology; D014621:Vagina / Q000382:microbiology
keywords: DNA chip; Genitourinary infection; Sexually transmitted disease (STD)