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.
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