Clinical Validation of the Sansure Human Papillomavirus DNA Diagnostic Kit for Use in Primary Cervical Cancer...

International guidelines require that human papillomavirus (HPV) assays intended for primary cervical cancer screening demonstrate adequate reproducibility and non-inferior clinical accuracy compared with validated comparator assays. The clinical performance of the Sansure Human Papillomavirus DNA Diagnostic Kit (Sansure HPV Kit), a multiplex real-time PCR assay detecting HPV16 and HPV18 individually and 13 additional HPV types in aggregate, was evaluated according to the Meijer study design. The applied Ct cut-off for HPV-positivity was ≤ 39. A panel of 890 clinician-collected cervical samples from women aged ≥ 30 years participating in routine screening in Belgium, including 90 histologically confirmed CIN2+ cases and 800 ≤ CIN1 controls was collated. The Abbott RealTime High Risk HPV assay served as the comparator test. Non-inferiority margins were ≥ 0.90 for relative sensitivity and ≥ 0.98 for relative specificity. Reproducibility was assessed through re-analysis of previously published data. After exclusion of four invalid samples, 886 samples were included in the accuracy analysis. Relative sensitivity compared with Abbott RealTime was 0.978 (95% CI: 0.947-1.009; pnon-inferiority = 0.007) for CIN2+ and 0.966 (95% CI: 0.921-1.013; pnon-inferiority = 0.045) for CIN3+. Relative specificity for ≤ CIN1 was 1.003 (95% CI: 0.991-1.014; pnon-inferiority = 0.0006). Reproducibility data demonstrated intra-laboratory agreement of 93.8% (κ = 0.842) and inter-laboratory agreement of 94.4% (κ = 0.856), exceeding the Meijer reproducibility thresholds. Considering the Ct clinical cutoff (≤ 39.0), the Sansure HPV Kit fulfils the established international validation criteria for clinical sensitivity, specificity, and reproducibility for use in primary cervical cancer screening using PreservCyt as storage medium for cervical samples. Consideration of genotype composition, including detection of HPV53 within a pooled channel, is warranted in the context of organised screening programmes.