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Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria
Author(s) -
Gage Julia C.,
Ajenifuja Kayode O.,
Wentzensen Nicolas,
Adepiti Akinfolarin C.,
Stoler Mark,
Eder Paul S.,
Bell Laura,
Shrestha Niwashin,
Eklund Claire,
Reilly Mary,
Hutchinson Martha,
Wacholder Sholom,
Castle Philip E.,
Burk Robert D.,
Schiffman Mark
Publication year - 2012
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.27563
Subject(s) - colposcopy , medicine , technician , cervical intraepithelial neoplasia , cervical cancer , human papillomavirus , gynecology , cervical cancer screening , obstetrics , cancer , electrical engineering , engineering
Success of the new human papillomavirus (HPV) DNA test for low‐resource settings ( care HPV™ 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 care HPV test nested within a cervical screening project in a large Nigerian village. Care HPV 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. Care HPV 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 care HPV). 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 care HPV 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