Improving diagnostic capability for HPV disease internationally within the NIH-NIAID Division of AIDS Clinical Trial Networks.
OBJECTIVE
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.
National Institute of Allergy and Infectious Diseases, National Institutes of Health, 6700 B Rockledge Dr, Bethesda MD 20892; Cgodfrey@niaid.nih.gov.
Catherine C
CC
Godfrey
Pamela M
PM
Michelow
Mandana
M
Godard
Vikrant V
VV
Sahasrabuddhe
Janice
J
Darden
Cynthia S
CS
Firnhaber
Neal T
NT
Wetherall
James
J
Bremer
Robert W
RW
Coombs
Timothy
T
Wilkin
D000163:Acquired Immunodeficiency Syndrome; D017322:Clinical Trials, Phase II as Topic; D005260:Female; D061809:Human Papillomavirus DNA Tests / Q000379:methods / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D008403:Mass Screening / Q000379:methods; D009316:National Institutes of Health (U.S.); D030361:Papillomavirus Infections / Q000175:diagnosis*; D010336:Pathology / Q000592:standards; D011785:Quality Assurance, Health Care / Q000379:methods / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D014481:United States; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*
Cervical cytology; Cervical pathology; EQA; External quality assurance; HPV; HPV DNA testing; Histopathology