The concordance of HPV DNA detection by Hybrid Capture 2 and careHPV on clinician- and self-collected specimens

Abstract Background care HPV is a new, lower-cost DNA test for human papillomavirus (HPV). There are limited analytic comparisons of care HPV against a referent HPV DNA test like Hybrid Capture 2 (HC2). Objective To assess the test agreement between care HPV and HC2 on self- and clinician-collected specimens. Study design In a population of 7541 women living in rural China, women provided a self-collected (sc) and two clinician-collected (cc) specimens and underwent visual inspection after acetic acid (VIA). The sc specimen and one cc specimen were tested by care HPV and HC2; a random subset of specimens was tested for HPV genotypes. Results The percent positive on cc specimens and sc specimens was 14.69% and 14.97% for care HPV, respectively, and 15.05% and 18.53% for HC2, respectively; HC2 testing of sc specimens was more likely to test positive than other combinations of tests and specimens ( p care HPV, respectively). Disagreement between the same test on different specimens increased with increasing participant age ( p trend  = 0.0001 for HC2 and 0.002 for care HPV). HC2-positive/ care HPV-negative specimens were more likely to test positive for non-carcinogenic HPV genotype than test HPV negative whereas the converse was true for HC2-negative/ care HPV-positive specimens. Discussion The agreement for HPV DNA detection between care HPV and HC2 was good to very good.