HPV testing for primary cervical screening: Laboratory issues and evolving requirements for robust quality assurance

Area of Science:

• Clinical Laboratory Science
• Molecular Diagnostics
• Public Health

Background:

• Cervical cancer screening relies heavily on accurate Human Papillomavirus (HPV) testing.
• Validation of HPV tests against international standards is essential for primary screening.
• Increasingly, validated HPV testing platforms require robust Quality Assurance Programs (QAPs).

Purpose of the Study:

• To emphasize the critical role of Quality Assurance (QA) in laboratories conducting HPV tests for cervical cancer screening.
• To outline the essential components of effective QA systems, including Internal Quality Assurance (IQA) and External Quality Assessment (EQA).
• To discuss the characteristics of high-quality HPV laboratories and necessary personnel training.

Main Methods:

• Review of international criteria for HPV test validation, focusing on clinical accuracy comparison.
• Description of established Internal Quality Assurance (IQA) and External Quality Assessment (EQA) systems.
• Analysis of existing EQAs, including their limitations, and considerations for optimal hrHPV primary screening EQA programs.

Main Results:

• The number of validated HPV testing platforms is growing, necessitating standardized QA.
• Effective QA, encompassing both IQA and EQA, is paramount for ensuring the longitudinal robustness and quality of HPV testing.
• Existing EQAs have limitations, highlighting the need for improved international collaboration and program development.

Conclusions:

• Implementing comprehensive QA systems (IQA and EQA) is vital for reliable HPV testing in cervical cancer screening.
• Standardized laboratory characteristics and personnel training are key to maintaining high-quality HPV testing processes.
• International collaboration is essential to enhance QA programs and ensure global consistency in HPV testing for cervical cancer screening.