Lab Med Online.  2021 Oct;11(4):267-274. 10.47429/lmo.2021.11.4.267.

Performance Evaluation of the CareGENE^TM Zika Virus Reverse Transcription-PCR Kit for Urine Specimen

• Kim GW
• Park BG
• Kwak SY
• Jang WS
• Nam J
• Lim CS

• KMID: 2526088
• DOI: http://doi.org/10.47429/lmo.2021.11.4.267

Abstract

Background
Zika virus (ZIKV) is a major health concern worldwide, highlighting the importance of accurate and reliable viral detection to control transmission. The careGENE^TM ZIKV Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Kit (Wells Bio, INC, Korea) was developed to detect Zika infection. We compared the clinical sensitivity and specificity of this kit with those of the Aptima Zika Virus Assay (Hologic, Inc., USA) and the World Health Organization (WHO)-recommended conventional PCR method.
Methods
A total of 168 urine samples (143 clinical samples and 25 RNA-spiked samples [ RNA-positive lyophilized plasma spiked in urine ]) were tested in this study.
Results
In comparison with the WHO-recommended conventional PCR method, the careGENE^TM ZIKV RT-PCR Kit detected ZIKV RNA with a sensitivity of 100% (95% confidence interval [ CI ], 73.5–99.9) and specificity of 100% (95% CI, 88.9–97.8). Similar results were obtained with the Aptima Zika Virus Assay, as evident from a sensitivity of 100% (95% CI, 73.5–99.9) and specificity of 100% (95% CI, 88.9–97.8). The limit of detection at a 95% detection probability was 1 U/mL in the urine.
Conclusions
Positive identification of Zika infection was selective and specific using the target Zika viral sequence. The overall performance of the careGENE^TM ZIKV RT-PCR Kit was satisfactory.

Keyword

Zika virus; Reverse transcription-PCR; Sensitivity; Specificity

Figure

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  Fig. 1 Information on the 168 urine specimens analyzed in this study. Abbreviations: ZIKV, zika virus; RT-PCR, reverse transcription-PCR.

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  Fig. 2 (A) Representative results of ZIKV-positive sample, both the target gene for ZIKV (blue, green) and the internal control gene (pink) were amplified. (B) Representative results of ZIKV-negative sample, only the internal control gene (pink) was amplified. Abbreviations: ZIKV, zika virus; GAPDH, glyceraldehyde 3-phosphate dehydrogenase.

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