Improving diagnostic capability for HPV disease internationally within the NIH-NIAID Division of AIDS Clinical Trial Networks.

TitleImproving diagnostic capability for HPV disease internationally within the NIH-NIAID Division of AIDS Clinical Trial Networks.
Publication TypeJournal Article
Year of Publication2013
AuthorsGodfrey CC, Michelow PM, Godard M, Sahasrabuddhe VV, Darden J, Firnhaber CS, Wetherall NT, Bremer J, Coombs RW, Wilkin T
Corporate AuthorsA5282 Study Team
JournalAm J Clin Pathol
Volume140
Issue6
Pagination881-9
Date Published2013 Dec
ISSN1943-7722
KeywordsAcquired Immunodeficiency Syndrome, Clinical Trials, Phase II as Topic, Female, Human Papillomavirus DNA Tests, Humans, Laboratories, Mass Screening, National Institutes of Health (U.S.), Papillomavirus Infections, Pathology, Quality Assurance, Health Care, Randomized Controlled Trials as Topic, United States, Uterine Cervical Neoplasms
Abstract

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.

DOI10.1309/AJCPIBIS19QIYHJY
Alternate JournalAm. J. Clin. Pathol.
PubMed ID24225757
PubMed Central IDPMC4017200
Grant ListAI27757 / AI / NIAID NIH HHS / United States
AI38858 / AI / NIAID NIH HHS / United States
HHSN272200800014C / / PHS HHS / United States
HHSN272201200023C / / PHS HHS / United States
HHSN272201300004C / / PHS HHS / United States
P30 AI027757 / AI / NIAID NIH HHS / United States
U01 AI038858 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
UM1 AI068636 / AI / NIAID NIH HHS / United States
UM1 AI069419 / AI / NIAID NIH HHS / United States
UM1 AI069439 / AI / NIAID NIH HHS / United States
UM1 AI069456 / AI / NIAID NIH HHS / United States
UM1 AI069463 / AI / NIAID NIH HHS / United States
UM1 AI069463-07 / AI / NIAID NIH HHS / United States