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 >or=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 >or=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.