Qiagen QiaScreen HPV PCR Test
Qiagen announced the European launch of its QiaScreen HPV PCR test, a CE-IVD marked molecular diagnostic assay for 15 recognized high-risk genotypes of human papillomavirus associated with cervical cancer. The assay is designed to detect a range of DNA targets within the E7 region of the HPV virus, providing the flexibility of PCR without the risk of false positives due to L1 deletion, Qiagen said. The clinical performance of the assay was tested using nearly 1,600 samples from the Valgent-3 panel, and was reported to have a clinical sensitivity and specificity to CIN3+ of 97.3 percent and 89.0 percent, respectively. The assay is designed for use on either clinician-collected or self-collected specimens, and it has been validated on Qiagen's Rotor-Gene Q MDx system. Qiagen also intends to offer a version of the test on the NeuMoDx 96 and 288 molecular systems in the future for customers desiring higher-volume testing and full integration.