Clinical Performance of the Full Genotyping Agena MassARRAY HPV Assay Using SurePath Screening Samples within the VALGENT4 Framework
The Journal of Molecular Diagnostics(2022)
摘要
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 array-based 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 cytology findings. The clinical accuracy of the MA-HPV assay for sensitivity and specificity was assessed relative to that of the general primer 5+/6+ PCR enzyme immunoassay (GP-EIA), by a noninferiority test. The type-specific concordance of the MA-HPV assay was assessed as well. The relative sensitivity of the MA-HPV assay for cervical intraepithelial neoplasia >= 2 or >= 3 was 1.02 (95% CI, 0.98-1.05) and 1.01 (95% CI, 0.99-1.04), 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, 0.85-0.91; P > 0.99). 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 where specificity is of lesser importance but where high sensitivity is paramount.
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