Development of a pilot proficiency program for human papillomavirus DNA detection

Area of Science:

• Molecular Diagnostics
• Virology
• Laboratory Medicine

Background:

• Human papillomavirus (HPV) DNA testing is now standard for cervical cancer screening in Australia.
• External quality assurance (EQA) is crucial for monitoring laboratory performance in HPV testing.
• A pilot program was developed to assess material stability for an ongoing external quality assurance program (EQAP).

Purpose of the Study:

• To evaluate the suitability and stability of different specimen types for an HPV DNA testing EQAP.
• To assess the performance of diagnostic laboratories using HPV DNA testing methods.
• To inform the development of a robust EQAP for molecular diagnostic laboratories.

Main Methods:

• Two types of specimens were evaluated: ThinPrep (cells in PreservCyt) and HPV-seeded swabs.
• Two sample panels were distributed 5 months apart to 18 Australian and 2 New Zealand laboratories.
• Laboratories used Hybrid Capture 2 (HC2) or alternative molecular methods for HPV DNA testing.

Main Results:

• Initial testing showed variable accuracy for ThinPrep and swab specimens across different methods.
• In the second panel, ThinPrep specimens achieved 100% correct reporting with HC2 and 95% with alternative methods.
• Swab specimens in the second panel showed high accuracy: 89% with HC2 and 100% with alternative methods.

Conclusions:

• Both ThinPrep and swab specimens are suitable for use in an HPV DNA testing EQAP.
• The study highlights the need for ongoing EQAP to assess the performance of molecular HPV testing methods.
• Results provide valuable data for establishing a reliable EQAP for diagnostic molecular laboratories.