Proficiency test for human papillomavirus genotyping in china

Area of Science:

• Medical Diagnostics
• Virology
• Public Health

Background:

• China utilizes diverse human papillomavirus (HPV) genotyping assays for cervical cancer screening.
• A standardized proficiency testing system is lacking for evaluating assay performance.
• This study aimed to assess laboratory capabilities in discriminating nine HPV types using a proficiency panel.

Purpose of the Study:

• To evaluate the performance of clinical laboratories in HPV genotyping.
• To identify variations in assay accuracy across different laboratories.
• To highlight the need for standardization in HPV testing.

Main Methods:

• A panel of 24 samples with known HPV types (6, 11, 16, 18, 31, 33, 39, 51, 52) at varying concentrations was prepared.
• The panel was distributed to 76 clinical laboratories for testing.
• Participant results were compared against established reference results.

Main Results:

• High accuracy was observed for HPV-16 (98.7%) and HPV-18 (96.0%) at 10^6 IU/ml.
• Approximately 90% accuracy was achieved for HPV-6, HPV-31, HPV-33, and HPV-52 at 10^6 GE/ml.
• Lower correct identification rates were noted for HPV-51 (42.7%), HPV-11 (55.6%), and HPV-39 (21.3%) at 10^6 GE/ml.

Conclusions:

• The developed proficiency test system provided a traceable panel for HPV genotyping evaluation.
• Significant performance disparities were identified among participating laboratories.
• There is a clear need for laboratories to enhance operational practices and standardize HPV genotyping methods.