title: Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria.
abstract: Success of the new human papillomavirus (HPV) DNA test for low-resource settings (careHPV™ test; QIAGEN Gaithersburg Inc., Gaithersburg, MD) requires good test performance when operated by personnel with limited laboratory experience. We evaluated the transferability, reliability, and accuracy of the careHPV test nested within a cervical screening project in a large Nigerian village. CareHPV testing was performed on screen-positive (n = 345) and screen-negative (n = 42) women attending colposcopy (68.3% of referred). Biopsies of abnormal-appearing areas were processed and read in the U.S. CareHPV specimens taken immediately before colposcopy were processed up to four times (in the field) by two secondary school graduates without laboratory experience, trained for this study. Specifically, QIAGEN Gaithersburg trained a laboratory-inexperienced U.S. researcher, who trained the first local technician who, in turn, trained the second. Residual specimens were sent to the U.S. for MY09/MY11 PCR testing for 13 carcinogenic genotypes (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) plus HPV66 (included in careHPV). Intrarater agreement was 98.8% (κ = 0.97) and 98.9% (κ = 0.97) for Technicians 1 and 2, respectively, while inter-rater agreement was 96.3% (κ = 0.90). Agreement with MY09/MY11 PCR (virologic reference standard) was 89.3% (κ = 0.73) with 74.2% sensitivity and 95.7% specificity. The careHPV test detected 12 (80%) of 15 histologically confirmed cervical intraepithelial neoplasia Grade 2 (CIN2) or worse lesions, with an estimated 83.0% specificity to detect <CIN2. In a challenging low-resource setting with minimal intervention, the careHPV test performed adequately with high specificity but possibly lower sensitivity than HPV DNA tests currently used in controlled situations.
authors.affiliation: Division of Cancer Epidemiology and Genetics, Clinical Genetics Branch, National Cancer Institute, National Institutes of Health, DHHS, Bethesda, MD, USA. gagej@mail.nih.gov
authors.forename: Julia C
authors.initials: JC
authors.lastname: Gage
authors.forename: Kayode O
authors.initials: KO
authors.lastname: Ajenifuja
authors.forename: Nicolas
authors.initials: N
authors.lastname: Wentzensen
authors.forename: Akinfolarin C
authors.initials: AC
authors.lastname: Adepiti
authors.forename: Mark
authors.initials: M
authors.lastname: Stoler
authors.forename: Paul S
authors.initials: PS
authors.lastname: Eder
authors.forename: Laura
authors.initials: L
authors.lastname: Bell
authors.forename: Niwashin
authors.initials: N
authors.lastname: Shrestha
authors.forename: Claire
authors.initials: C
authors.lastname: Eklund
authors.forename: Mary
authors.initials: M
authors.lastname: Reilly
authors.forename: Martha
authors.initials: M
authors.lastname: Hutchinson
authors.forename: Sholom
authors.initials: S
authors.lastname: Wacholder
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
authors.forename: Robert D
authors.initials: RD
authors.lastname: Burk
authors.forename: Mark
authors.initials: M
authors.lastname: Schiffman
mesh_terms: D052685:Alphapapillomavirus / Q000235:genetics*; D001706:Biopsy; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D006801:Humans; D009549:Nigeria; D011933:Reagent Kits, Diagnostic; D012424:Rural Population; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000821:virology
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic