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Patel, R., Kennedy, O.J., Clarke, E., Geretti, A., Nilsen, A., Lautenschlager, S., Green, J., Donders, G., van der Meijden, W., Gomberg, M., Moi, H. and Foley, E. (2017) 2017 European Guidelines for the Management of Genital Herpes. International Journal of STD & AIDS, 28, 1366-1379. https://doi.org/10.1177/0956462417727194

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• TITLE: Consistency Analysis of Detection Results of Two Herpes Simplex Virus (HSV) Type II Nucleic Acid Detection Kits

  AUTHORS: Weihua Xu, Wei Gong, Xinping Chen

  KEYWORDS: Herpes Simplex Virus (HSV) Type II, Nucleic Acid Detection Kits, Consistency Analysis

  JOURNAL NAME: Open Journal of Medical Microbiology, Vol.12 No.3, September 20, 2022

  ABSTRACT: Objective: The objective of the study is to verify the clinical validity of the following kits with the comparative experimental analysis and evaluate whether their performance can meet the clinical requirements, i.e. Class III in vitro diagnostic reagent “Herpes Simplex Virus (HSV) Type II Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)” of Daan Gene Co., Ltd. (Daan kit for short) and “Herpes Simplex Virus (HSV) Type II Nucleic Acid Detection Kit (Fluorescence PCR Method)” of Wuhan Biot Gene Co., Ltd. (Biot kit for short). Method: In the study process, the samples were divided into positive and negative groups according to the control test results, and the clinical application performance of Daan kit and Biot kit was evaluated by comparing their test results. Results: The results show that two kits indicate the same test results, i.e. 26 positive and 107 negative samples in a total of 133 male urethral discharge samples, and 32 positive and 238 negative samples in a total of 270 female cervical secretion samples. Conclusion: It can be concluded from the clinical test that Daan and Biot Herpes Simplex Virus (HSV) Type II Nuc- leic Acid Test Kits are reliable, accurate, safe, convenient for use, stable and high-value in the clinical application.