Clinical Performance of the Full Genotyping Agena MassARRAY HPV Assay Using SurePath Screening Samples within the VALGENT4 Framework

Abstract

The clinical performance evaluation of the novel MassARRAY human papillomavirus (MA-HPV) assay was performed using Danish SurePath cervical cancer screening samples under the fourth Validation of HPV Genotyping Tests (VALGENT) framework. The MA-HPV assay is a mass arrayebased assay that individually detects 14 oncogenic HPV genotypes and five nononcogenic types. The MA-HPV assay was validated using the VALGENT4 panel, which constitutes 997 consecutive samples from a screening population in addition to 297 disease-enriched samples with abnormal cytologic findings. The clinical accuracy of the MA-HPV assay for sensitivity and specificity was assessed relative to that of the general primer 5þ/6þ PCR enzyme immunoassay (GP-EIA), by a noninferiority test. The type-specific concordance of the MA-HPV assay with the GP5þ/6þ PCR with Luminex (GP-LMNX) genotyping was assessed as well. The relative sensitivity of the MA-HPV assay for cervical intraepithelial neoplasia 2 or 3 was 1.02 (95% CI, 0.98e1.05) and 1.01 (95% CI, 0.99e1.04), respectively. The sensitivity of the MA-HPV was noninferior to that of the GP-EIA (P Z 0.0001), whereas the specificity of the MA-HPV was inferior (0.89; 95% CI, 0.85e0.91; P > 0.99). The genotype concordance between the MA-HPV and GP-LMNX was good for most oncogenic types. The MA-HPV assay is a clinical sensitive assay with a lower clinical specificity compared with the GP-EIA. The assay in its current form seems more suited to play a role in settings where specificity is of lesser importance but where high sensitivity is paramount. Q6

Perspective Chapter: Predictive Genomics

“…Genetic analysis of SNPs can be done using various body materials as a source of human DNA such as saliva/buccal smears [37], blood samples [27,38,39], bone marrow cell lines [40], cytological liquid samples [41], formalin-fixed paraffin-embedded (FFPE) tissue [24,26,[42][43][44].…”