QIAscreen HPV PCR Test
For detection of human papillomavirus infections using PCR technology
The QIAscreen HPV PCR Test is an in vitro real-time PCR-based assay for the qualitative detection of human papillomavirus (HPV) DNA of the following 15 (likely) 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.
Clinical performance on cervical specimens (scrapes)
The clinical sensitivity and specificity of the test for cervical intraepithelial neoplasia grade 2 or higher (CIN 2+) in cervical specimens (scrapes) were validated by a non-inferiority analysis relative to high-risk HPV GP5+/6+ PCR following international guidelines for HPV test requirements for cervical cancer screening (1). The clinical sensitivity for CIN 2+ was 97.1% (67/69) and the clinical specificity for CIN 2+ was 94.3% (777/824). The clinical sensitivity and specificity were non-inferior to that of the reference assay GP5+/6+ PCR (2), indicating a very good clinical performance.
Performance on self-collected (cervico-)vaginal specimens
The performance of the test 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 CIN 2+ sensitivity of 91.4% (21/23) (2). For self-collected brush specimens, the agreement with GP5+/6+ PCR was 93% (104/112) with a CIN 2+ sensitivity of 93.9% (31/34) (2).
The QIAscreen HPV PCR Test is a multiplex, real-time PCR-based assay directed against the E7 gene of 15 (probably) hrHPV types that uses fluorescent probes for the detection of one or more accumulating PCR products. During each PCR cycle the fluorescent signal increases in a logarithmic manner resulting in an amplification curve. As soon as the amplification curve of the target comes above its threshold, the sample is considered positive for that target. The multiplex format allows the simultaneous detection of four different fluorescent dyes per reaction, with each fluorescent dye representing different targets. The four different targets are: 1. HPV 16, 2. HPV 18, 3. the 13 other hrHPV types as a pool and 4. the human β-globin gene. The QIAscreen HPV PCR Test separately detects HPV 16, HPV 18 and the pool of 13 other hrHPV genotypes. The human β-globin gene is used as the sample control determining both the quality of the sample DNA and the presence of potential inhibitory substances.
The QIAscreen HPV PCR Test is an in vitro real-time PCR-based assay for the qualitative detection of human papillomavirus (HPV) DNA of the following 15 (likely) 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. The QIAscreen HPV PCR Test runs on the Rotor-Gene Q MDx instrument.
This product is intended to be used by professional users, such as technicians and laboratorians who are trained in in vitro diagnostics procedures, molecular biological techniques, and the Rotor-Gene Q MDx system.
2. Hesselink, A. et al. (2014) Clinical validation of the HPV-Risk assay: a novel, real-time PCR assay for the detection of high-risk human papillomavirus DNA by targeting the E7 region. J. Clin. Microbiol. 52, 890.
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