1. Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings
- Author
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Anja Šterbenc, Mario Poljak, Katja Seme, and Anja Oštrbenk Valenčak
- Subjects
Adult ,Microbiology (medical) ,Oncology ,medicine.medical_specialty ,Genotype ,Cytological Techniques ,Population ,Uterine Cervical Neoplasms ,Cervical cancer screening ,03 medical and health sciences ,0302 clinical medicine ,Virology ,Internal medicine ,medicine ,Humans ,Mass Screening ,030212 general & internal medicine ,Human papillomavirus ,education ,Papillomaviridae ,Genotyping ,Early Detection of Cancer ,Cervical cancer ,education.field_of_study ,business.industry ,Papillomavirus Infections ,Hybrid capture ,Reproducibility of Results ,Uterine Cervical Dysplasia ,medicine.disease ,female genital diseases and pregnancy complications ,Molecular Typing ,Colposcopy ,030220 oncology & carcinogenesis ,DNA, Viral ,Female ,Test requirements ,business - Abstract
The Alinity m HR HPV assay (Alinity) is a novel human papillomavirus (HPV) assay that individually identifies genotypes HPV16, HPV18, and HPV45 while reporting on 11 other high-risk HPV (hrHPV) genotypes in two aggregates: HPV31/33/52/58 and HPV35/39/51/56/59/66/68. The clinical performance of Alinity for screening for cervical cancer was evaluated in population-based settings. For women aged ≥30 years, the clinical sensitivity (n = 68) and specificity (n = 3,077) for the detection of cervical intraepithelial neoplasia grade 2+ (CIN2+) of Alinity were 100.0% and 92.4%, respectively, and were not inferior to those of the Qiagen Digene Hybrid Capture 2 high-risk HPV DNA assay (hc2) (P = 0.0006 and P
- Published
- 2019