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

Abstract

Success of the new 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). Intra-rater agreement was 98.8% (Kappa=.97) and 98.9% (Kappa=.97) for technicians 1 and 2, respectively while inter-rater agreement was 96.3% (Kappa=.90). Agreement with MY09/MY11 PCR (virologic reference standard) was 89.3% (Kappa=.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.

Clinical Evaluation of Human Papillomavirus Detection by careHPVTMTest on Physician-Samples and Self-Samples using The Indicating FTA Elute® Card

“…Previous studies of careHPV TM have shown sensitivity and specificity that approach that of HC2, a U.S. Food and Drug Administration-approved test (Qiao et al, 2008;Zhao et al, 2010). Moreover, the workflow of careHPV TM is similar but simpler than the HC2 test with a lower cost and simpler administration, and can be run by secondary school graduates without laboratory experience, using a training of the trainer model (Gage et al, 2012). In Dec of 2013, the latest WHO guidelines recommended using HPV testing as the primary screening method for cervical cancer in areas with enough resources.…”

An Evaluation of Novel, Lower-Cost Molecular Screening Tests for Human Papillomavirus in Rural China

“…Preliminary studies of careHPV have shown sensitivity and specificity that approach that of Hybrid Capture 2 (HC2; QIA-GEN; ref. 11), a U.S. Food and Drug Administrationapproved test, and can be run by secondary school graduates without laboratory experience, using a training of the trainer model (12).…”

Optimal Positive Cutoff Points for careHPV Testing of Clinician- and Self-Collected Specimens in Primary Cervical Cancer Screening: an Analysis from Rural China

“…Specialized training and education are not required to run the test. It has been evaluated in multiple countries and found that careHPV is a sensitive and reasonably specific screening test for cervical precancer and cancer (7)(8)(9)(10)(11)(12). In 2012, the China Food and Drug Administration approved this test for cervical cancer screening (13).…”