Improving Diagnostic Capability for HPV Disease Internationally Within the NIH-NIAID Division of AIDS Clinical Trial Networks

Objectives: To evaluate an external quality assurance (EQA) program for the laboratory diagnosis of human papillomavirus (HPV) disease that was established to improve international research capability within the Division of AIDS at the National Institute of Allergy and Infectious Disease–supported Adult AIDS Clinical Trials Group network. Methods: A three-component EQA scheme was devised comprising assessments of diagnostic accuracy of cytotechnologists and pathologists using available EQA panels, review of quality and accuracy of clinical slides from local sites by an outside expert, and HPV DNA detection using a commercially available HPV test kit. Results: Seven laboratories and 17 pathologists in Africa, India, and South America participated. EQA scores were suboptimal for EQA proficiency testing panels in three of seven laboratories. There was good agreement between the local laboratory and the central reader 70% of the time (90% confidence interval, 42%-98%). Performance on the College of American Pathologists’ HPV DNA testing panel was successful in all laboratories tested. Conclusions: The prequalifying EQA round identified correctable issues that will improve the laboratory diagnosis of HPV-related cervical disease at the participating international study sites and will provide a mechanism for ongoing education and continuous quality improvement. Cervical cancer is the third most common cancer in women globally, and most of the burden occurs in resourcelimited settings. These areas have a disproportionate mortality: the age-specific mortality rates for women in resourcelimited countries are at least triple those of women in resource-rich environments. Human immunodeficiency virus (HIV)–infected women bear a greater burden of disease than uninfected women, and the high mortality rates from cervical cancer in the younger age groups in resource-limited countries