Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria

Julia C. Gage, Kayode O. Ajenifuja, Nicolas Wentzensen, Akinfolarin C. Adepiti, Mark Stoler, Paul S. Eder, Laura Bell, Niwashin Shrestha, Claire Eklund, Mary Reilly, Martha Hutchinson, Sholom Wacholder, Philip E. Castle, Robert D. Burk, Mark Schiffman

Research output: Contribution to journalArticle

33 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2903-2909
Number of pages7
JournalInternational Journal of Cancer
Volume131
Issue number12
DOIs
StatePublished - Dec 15 2012

Keywords

  • HPV DNA testing
  • cervical cancer prevention
  • screening
  • test accuracy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Gage, J. C., Ajenifuja, K. O., Wentzensen, N., Adepiti, A. C., Stoler, M., Eder, P. S., Bell, L., Shrestha, N., Eklund, C., Reilly, M., Hutchinson, M., Wacholder, S., Castle, P. E., Burk, R. D., & Schiffman, M. (2012). Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria. International Journal of Cancer, 131(12), 2903-2909. https://doi.org/10.1002/ijc.27563