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J Clin Lab Anal. 2019 Mar;33(3):e22703. doi: 10.1002/jcla.22703. Epub 2018 Nov 2.

Comparison between DiaPlexQ™ STI6 and GeneFinder™ STD I/STD II multiplex Real-time PCR Kits in the detection of six sexually transmitted disease pathogens.

Author information

1
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
2
Green Cross Genome, Yongin, South Korea.
3
Center for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Korea.
4
Eone Laboratories, Incheon, Korea.

Abstract

BACKGROUND:

The DiaPlexQ™ STI6 Detection Kit (DiaPlexQ; Solgent Co., Ltd., Daejeon, South Korea) is a multiplex real-time PCR assay for the detection of the following sexually transmitted disease (STD) pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma hominis, Trichomonas vaginalis, Ureaplasma urealyticum, and Mycoplasma genitalium. We compared the performance of the DiaPlexQ assay with the GeneFinder™ STD I (CT/NG/UU) and STD II (MG/MH/TV) Multiplex Real-time PCR Kits (GeneFinder; Infopia Co., Ltd., Anyang, South Korea).

METHODS:

We evaluated the performance of the DiaPlexQ assay in comparison to that of GeneFinder using 1106 clinical specimens (542 genital swabs and 564 urine samples). The analytical performance of the DiaPlexQ assay, including the limit of detection (LOD) and analytical specificity, was evaluated using reference strains.

RESULTS:

The positive percent agreement, negative percent agreement, and kappa value between the two assays were 96.6%-99.4%, 98.2%-99.8%, and 0.93%-0.99%, respectively. No cross-reactivity was observed in a collection of 41 different microorganisms and the LOD of the DiaPlexQ assay ranged from 1 to 10 copies/reaction for each microorganism.

CONCLUSION:

The DiaPlexQ assay showed comparable performance to that of the GeneFinder assay so that it can be used for the screening and diagnosis of non-viral curable STD pathogens.

KEYWORDS:

multiplex real-time PCR; sexually transmitted disease; validation

PMID:
30390337
DOI:
10.1002/jcla.22703
[Indexed for MEDLINE]

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