A comparison of Linear Array and Hybrid Capture 2 for detection of carcinogenic human papillomavirus and cervical precancer in ASCUS-LSIL triage study

Background: We were interested in comparing the performance of Linear Array (LA; Roche Molecular Systems) to Hybrid Capture 2 (hc2; Digene) for the detection of carcinogenic human papillomavirus (HPV) and cervical precancer. Methods: LA and hc2 results were compared on baseline specimens collected from women with an atypical squamous cells of undetermined significance (ASCUS) Pap referred into ASCUS and Low-Grade Squamous Intraepithelial Lesion Triage Study (n=3,488). hc2 was conducted at the time of the study on liquid cytology specimens. LA was conducted retrospectively on aliquots from a second, stored cervical specimen masked to the hc2 results and clinical data. Paired LA and hc2 results (n=3,289; 94%) were compared for the detection of carcinogenic HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and 2-year cumulative cervical intraepithelial neoplasia (CIN) grade : 3 as diagnosed by the quality-control pathology review. Results: LA was more likely to test positive for carcinogenic HPV than hc2 (55% versus 53%; P=0.001). For 2-year cumulative >= CIN3, LA and hc2 had similar sensitivities (93.3% versus 92.6%, respectively; P=1), and LA was marginally less specific than hc2 (48.1% versus 50.6%, respectively; P=0.05). LA and hc2 had similar negative predictive values (98.70% versus 98.64% respectively; P=0.4), and LA had a slightly lower positive predictive value than hc2 (14.6% versus 15.1%, respectively; P < 0.0001). Conclusion: We observed that LA and hc2 performed similarly in the detection of carcinogenic HPV and identification of CIN3 among women with an ASCUS Pap.