Description

The infection by papillomarivus at risk (HPV HR) is a condition required for pre-cancer and cervical cancer development.
The HPV screening with the PapilloCheck® microarray allows identification of 24 HPV types. Among, these, 18 HPV are classified high risk and 6 low risk.

HPV high risk : 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, 82.
HPVlow risk : 6, 11, 40, 42, 43, 44.

While competitors HPV test systems allow only HPV classification into a high or a low HPV group, PapilloCheck^® makes possible 24 HPV detection simultaneously, improving diagnosis quality. PapilloCheck^® guarantees high detection specificity and sensibility.

Reference	Designation
465 060	HPV screening kit- PapilloCheck® (60 reactions) HPV kit contains: 5 microarrays for 12 tests each Mastermix PCR Hybridation Buffer Wash Buffers A & B

Specifications

The test is based on the detection of E1 gene fragment of 24 HPV types.
The first step is the extraction of viral DNA from a cervical specimen. A fragment of 350pb of the E1 gene is amplified by PCR in presence of specific HPV primers. To avoid false-negative results, a fragment of house keeping gene ADAT1 (adenosine deaminase 1) is amplified in the same experiment.

The amplification products are hybridized for only 15 minutes at room temperature. Every chip has 12 arrays allowing simultaneous analysis of 12 samples. During hybridization, probes are labelled with fluorescent dyes. Chips are washed to eliminate unbound DNA and then analysed.

PapilloCheck^® features:

DNA chip for specific identification of 18 high risk HPV and 6 low risk.
First and second intention test for the cervical cancer screenings.
Label CE (IVD). Recording made within the framwork of quantitative HPV detection on samples.

PapilloCheck^® kit content

• 5 slides with 12 tests each
• Mastermix PCR
• Hybridization buffer
• Wash Buffer A
• Wash Buffer B
• CheckReport^™ software with user guide

• Certified in-vitro diagnostic (IVD) for simultaneous genotyping of 24 different types of HPV.
• Controls integrated on the chip – Controls and patient in a single sample.
• High specificity and high sensibility.
• Automated scan, evaluation and HPV report generation.