To appropriately evaluate and control the performance quality of HPV tests for major agreed-upon clinical indications, in addition to the appropriate guidelines we also need carefully designed and robust quality assurance programs. The number of HPV tests clinically validated for primary cervical cancer screening is increasing and appropriate quality assurance programs which can interrogate longitudinal robustness and quality are paramount.
Because the proper function of all testing steps (e.g., nucleic acid extraction, amplification and analysis of amplified products) determines the final clinical sensitivity and specificity of HPV testing, when designing quality assurance programs for evaluating and controlling the clinical performance of HPV tests one should produce panel members that mimic clinical samples as much as possible in terms of composition (human cells), transportation medium (with/without fixative), and total volume (greater than the minimum volume requested for pre-analytical processing). The main characteristics of a laboratory preforming HPV-based cervical cancer screening and the personnel training needs to ensure an elevated quality of the entire process and the optimal use of the resources will be discussed. Additionally, the quality assurance, as both internal and external quality assessment systems, to be implemented and performed, as well as the description of the five major current HPV quality assurance programs (UK NEQAS, QCMD, DicoCare VEQ HPV-DNA HR, WHO HPV LabNet and Instand) and their advantages and limitations will be summarized and briefly commented.
Further international efforts are necessary that relevant standards, quality assessment programs, validation metrics and quality guidelines evolve to the level to suit the constantly changing nature of cervical cancer screening.