GeneProof Human Papillomavirus (HPV) PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for the detection of 24 high-risk types of Human Papillomavirus (HPV) and typization of HPV 16, 18, 45 by the real-time Polymerase Chain Reaction (PCR) method.
The HPV detection consists in amplification of specific conservative DNA sequence in the area of E1/E2 genes and in measurement of fluorescence increase. The kit enables detection of following high-risk types HPV: 16, 18, 26, 30, 31, 33, 34, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 97. The high-risk types HPV presence is indicated by the FAM fluorofore fluorescence growth. The kit enables simoultaneously type HPV 16, 18 a 45. The HPV16 presence is indicated in the Cy5 fluorofore fluorescence channel, HPV 18 in the Texas Red fluorescence channel and HPV 45 in the Cy5.5 fluorescence channel. For the DNA isolation quality control and possible PCR inhibition control there are primers and probe for GAPDH gene amplification present in the reaction mix. Amplification of GAPDH gene is indicated in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.
This PCR kit can be used as a screening test in the cervical cancer screening program.
TECHNICAL SPECIFICATION
| Technology | real-time PCR | |||||||||||||||||||||||||||||||||||||||||
| Type of Analysis | qualitative | |||||||||||||||||||||||||||||||||||||||||
| Target sequence | E1/E2 gene | |||||||||||||||||||||||||||||||||||||||||
| Analytical Specificity | Human Papillomavirus high-risk types 16, 18, 26, 30, 31, 33, 34, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 97 with differentiation of 16, 18 and 45 types | |||||||||||||||||||||||||||||||||||||||||
| Analytical Sensitivity (LoD) | reaches up to 745 IU/ml for HPV 16 reaches up to 1561 IU/ml for HPV 18 |
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| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control (ISEX version) | |||||||||||||||||||||||||||||||||||||||||
| Validated Specimen | cervical, penis and vaginal swab, LBC | |||||||||||||||||||||||||||||||||||||||||
| Storage | -20 ± 5 °C | |||||||||||||||||||||||||||||||||||||||||
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation KitSiemens VERSANT® kPCR Molecular System |
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| Instruments |
* Detection of HPV types depending on the availability of appropriate fluorescence channels. |
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| Required Detection Channels | FAM, HEX, Cy5, Tex615, Tye705 | |||||||||||||||||||||||||||||||||||||||||
| Quality Control | In accordance with ISO 13485, each lot of GeneProof PCR Kit is tested against predetermined specifications to ensure consistent product quality | |||||||||||||||||||||||||||||||||||||||||
| External Quality Assessment | regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com | |||||||||||||||||||||||||||||||||||||||||
| Certification | CE IVD for in vitro Diagnostics Use | |||||||||||||||||||||||||||||||||||||||||
* Validated Instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Human Papillomavirus (HPV) PCR Kit | HPVS/ISEX/025 | real-time PCR | 25 reaction |
| GeneProof Human Papillomavirus (HPV) PCR Kit | HPVS/ISEX/050 | real-time PCR | 50 reaction |
| GeneProof Human Papillomavirus (HPV) PCR Kit | HPVS/ISEX/100 | real-time PCR | 100 reaction |