The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer.

OBJECTIVE: Evaluate the significance of BMRT HPV assay viral load and its performance for secondary screening. METHODS: BMRT-HPV reports type-specific viral loads/10,000 cells. We tested 1,495 physician collected, stored specimens from Chinese Multiple-center Screening Trial (CHIMUST), that were positive by Cobas, SeqHPV, and/or Cytology (≥LSIL); and 2,990 age matched, negatives in a nested case control study. We explored the relationship between BMRT HR-HPV viral load and cervical lesions, determined alternative CIN2+ cut-points by ROC curve, and evaluated BMRT HR-HPV for primary / secondary cervical cancer screening. RESULTS: The viral loads of HPV16/18, 12 other subtypes HR-HPV and 14 HR-HPV were statistically different in all grades of cervical lesions (P 0.05), specificity was higher than Cobas (84.8% vs 83.3%, 83.5% vs 82.0%, P 0.05). However, the BMRT HR-HPV viral load combined with subtypes did not require cytology. CONCLUSION: BMRT is as sensitive as Cobas4800 for primary cervical cancer screening. BMRT HR-HPV viral load combined with subtypes can be used as a secondary strategy for cervical cancer screening, especially for areas with insufficient cytological resources.