The HPV-Risk Assay is an in vitro real-time PCR-based assay for the qualitative detection of human papillomavirus (HPV) DNA, targeting the E7 region of the following 15 (probably) high-risk HPV genotypes, i.e., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68. The assay is intended to be used for the screening of women for the risk of cervical (pre)cancer.
Special features of the HPV-Risk Assay:
The HPV-Risk Assay has been clinically validated according to the international guidelines for HPV test requirements for cervical cancer screening (ref 5, 12). The clinical sensitivity and specificity were non-inferior to that of the reference assays, both GP5+/6+-PCR and HC2, indicating a very good clinical performance (ref 5, 12).
The performance of the HPV-Risk Assay in self-collected (cervico-)vaginal specimens has been validated for two different sampling methods: 1) self-collected lavage specimens, and 2) self-collected brush specimens. For self-collected lavage specimens, the agreement with the reference assay GP5+/6+-PCR was 97% (59/61) with a CIN2+ sensitivity of 91.4% (21/23). For self-collected brush specimens the agreement with GP5+/6+-PCR was 93% (104/112) with a CIN2+ sensitivity of 93.9% (31/34) (ref 5).
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