Clinical and analytical evaluation of the Alinity m HR HPV assay within the VALGENT-3 framework

Only clinically validated human papillomavirus (HPV) tests should be used in cervical cancer screening. VALGENT provides a framework to validate new HPV tests. In the VALGENT-3 study, the clinical accuracy of the recently launched Abbott Alinity m HR HPV assay (Alinity m) to detect cervical precancerous lesions was assessed against the standard comparator test (Hybrid Capture 2; HC2) and additionally against two previously validated alternative comparator tests (Abbott RealTime HR HPV and Roche cobas 4800 assays). Validation was conducted using 1,300 consecutive cervical samples from women attending an organized population-based cervical screening program enriched with 300 cytologically abnormal samples. Overall hrHPV test concordance was assessed by kappa values; the concordance for HPV-16 and HPV-18 was assessed for Alinity m, RealTime, and cobas, and the Linear Array (Roche) was used for more detailed genotyping concordance. In the total study population, the relative sensitivity and specificity for CIN2+ and CIN3+ of Alinity m compared to HC2 was 1.02 (95% CI:0.99–1.06) and 1.03 (95% CI:0.99–1.06), respectively. The relative specificity for ≤ CIN1 was 1.01 (95% CI:1.00–1.02) (all pni ≤ 0.001). Alinity m showed non-inferior clinical accuracy among women 30 years or older when cobas or RealTime were used as comparators. HPV genotype-specific concordance between Alinity m and the three comparator tests showed excellent agreement, with kappa values ranging between 0.82 and 1.00. In conclusion, Alinity m fulfils the international accuracy requirements for use in cervical cancer screening and shows excellent HPV genotype-specific concordance with three clinically validated HPV tests.