Aptima HPV and Aptima genotype assays for triage of borderline squamous (ASCUS) cytology: CLEAR study
May 2015—The characterization of the HPV genome and development of techniques that have the ability to detect nucleic acids in cytologic specimens has had a major impact on patient management. The Hybrid Capture 2 High-Risk HPV DNA Test, or HC2 (Qiagen, Gaithersburg, Md.), which uses probes designed to target the entire HPV genome, was cleared by the FDA in 1996. It was soon realized that determination of clinical sensitivity and specificity was essential to fully characterize assay performance and understand and classify correlation with cervical disease.