PapilloCheck® / PapilloCheck® high-risk/PapilloCheck® Collection Kit/CarnoCheck®
Persistent infection with a carcinogenic high-risk human papillomavirus (HPV) is found in virtually all cases of cervical cancer. Papillo Check® is a CE-certified in-vitro diagnostic kit (CE-IVD) for the qualitative detection and genotyping of 24 pathogenic HPV types (18 high-risk and 6 low-risk types) in DNA preparations from human cervical smears. The assay is based on detection and identification of a fragment of the viral E1 gene using a DNA microarray and allows the simultaneous processing of 12 cervical samples.
Prior to the PapilloCheck® analysis, DNA has to be extracted from a cervical specimen. Dedicated products for specimen collection (PapilloCheck® Collection Kit) and DNA extraction (oCheck® DNA Extraction Kit) are also available from Greiner Bio-One. After DNA extraction, a 350 bp fragment of the viral E1 gene is amplified by polymerase chain reaction (PCR) and the fluorescencelabelled PCR products are then hybridised to specific DNA probes attached to the chip surface. Unbound DNA is removed in the subsequent washing steps. Finally, the PapilloCheck® DNA chip is automatically scanned, analysed and evaluated using the CheckScanner™ and CheckReport™ Software respectively. The Greiner Bio-One PapilloCheck® test kit uses on-chip controls to monitor critical steps of the assay and chip processing, e.g. presence of human material in the cervical specimen, DNA extraction, PCR and hybridisation, as well as printing quality. Additionally, implementation of dUTP in the PCR Master Mix enables the elimination of potential carry-over contaminations from previous PCR reactions.PapilloCheck® high-risk
On the basis of the nearly absolute etiologic link between HPV and cervical cancer, testing for high-risk HPV is now considered in primary cervical cancer screening. The newly developed PapilloCheck® high-risk test kit (CE-IVD) is designed to meet the demands of cervical cancer screening by targeting 14 of the most carcinogenic high-risk HPV types (hrHPV). The microarraybased test kit allows the simultaneous identification of all HPV types detectable, which differ in their carcinogenic potential, using exactly the same technology as the approved PapilloCheck®.PapilloCheck® Collection Kit
The newly designed and CE-certified PapilloCheck® Collection Kit (Fig. 3) consists of a cervical brush and a vial filled with specimen transport medium wrapped in a blister package. The cervical brush is designed to simultaneously sample both the ecto- and endocervix. Additionally, it is equipped with a snap-off head, which remains in the storage vial after collecting the sample, thus ensuring that the entire sample is collected. The dimensions of the new storage vial ensure an easy and secure handling of the sample for downstream DNA extraction and PapilloCheck® analysis even with the snap-off head remaining in the vial. The special specimen transport medium guarantees optimal storage conditions and a transport free of contamination and DNA degradation.CarnoCheck®
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