Quality Management

Study on the Consistency Evaluation of Human Papillomavirus Nucleic Acid Detection Proficiency

  • Tian Yabin ,
  • Jiang Deyun ,
  • Ren Shanshan ,
  • Liu Yadan ,
  • Li Lili ,
  • Xu Sihong
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  • National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Resaerch and Evaluation of Medical Devices, NMPA Key Laboratory for Quality Resaerch and Evaluation of In Vitro Diagnostics, Beijing 100050, China

Received date: 2024-11-06

  Online published: 2025-05-27

Abstract

Objective: To carry out the research on the consistency evaluation of human papillomavirus(HPV) nucleic acid detection ability, evaluate the HPV nucleic acid detection proficiency of different domestic laboratories, so as to promote the mutual recognition of HPV nucleic acid detection results in domestic laboratories. Methods: HPV samples containing 14 different high-risk types (HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68) and 2 low-risk types (HPV-6, -11) were prepared with both type specificity and quantitative accuracy. Then panel was sent to different laboratories in the form of blind samples for testing. The proficiency study results were evaluated by the method of total integral grading evaluation. Results: A total of 27 laboratories participated in this proficiency study, of which 22 laboratories’ test results were “satisfactory” and 5 laboratories’ test results were “unsatisfactory”, with a satisfaction rate of 81.5%. Conclusion: The capacity of HPV test in different laboratories varies greatly, and the detection ability of some laboratories is poor. It is recommended to analyze the causes, strengthen laboratory training and timely rectification from four aspects: personnel, equipment, kit and quality control, so as to improve their laboratory testing capabilities.

Cite this article

Tian Yabin , Jiang Deyun , Ren Shanshan , Liu Yadan , Li Lili , Xu Sihong . Study on the Consistency Evaluation of Human Papillomavirus Nucleic Acid Detection Proficiency[J]. Chinese Pharmaceutical Affairs, 2025 , 39(4) : 430 -438 . DOI: 10.16153/j.1002-7777.2024-11-0017

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