Clinical laboratory evaluation of Invader® chemistry and hybrid capture for detection of high-risk human papillomavirus in liquid-based cytology specimens.

A laboratory-developed test for high-risk human papillomavirus (HPV) that utilizes the Invader technology (Hologic, Madison, WI, USA) was compared to hybrid capture (Digene, Gaithersburg, MD, USA). A total of 342 ThinPrep specimens were de-identified following cytology screening (10 high-grade squamous intraepithelial lesions, 14 low-grade squamous intraepithelial lesions, 199 atypical squamous cells of undetermined significance, 119 normal). DNA was manually extracted prior to interrogation with Invader. Hybrid capture/Invader discrepancies were subject to HPV sequencing. One sample (0.3%) was indeterminate by Invader due to low genomic DNA content. Concordance of 341 available tandem hybrid capture/Invader results occurred at a rate of 91.5%. Differences in HPV detection rate between the 2 assays were not statistically significant (P = 0.17). A propensity for false-positive hybrid capture result was confirmed by HPV sequencing in 83% of instances. Manual DNA extraction efficacy did not statistically differ between cytologic classifications (P ≥ 0.19). Invader detection of high-risk HPV is comparably sensitive and more specific than hybrid capture, providing an alternative for molecular HPV detection.