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J Microbiol Methods. 2015 Feb;109:117-22. doi: 10.1016/j.mimet.2014.12.010. Epub 2014 Dec 19.

Performance evaluation of a DNA chip assay in the identification of major genitourinary pathogens.

Author information

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.

KEYWORDS:

DNA chip; Genitourinary infection; Sexually transmitted disease (STD)

PMID:
25533217
DOI:
10.1016/j.mimet.2014.12.010
[Indexed for MEDLINE]

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