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GeneProof Team
Unique detection of 24 high-risk HPV types
Product name | Catalog no. | Technology | Packaging |
GeneProof Human Papilloma Virus (HPV) Screening PCR Kit | HPVS/GP/025 | real-time PCR | 25 reactions |
GeneProof Human Papilloma Virus (HPV) Screening PCR Kit | HPVS/GP/050 | real-time PCR | 50 reactions |
GeneProof Human Papilloma Virus (HPV) Screening PCR Kit | HPVS/GP/100 | real-time PCR | 100 reactions |
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 0.745 IU/μl with the probability of 95 % |
Diagnostic Specificity | 99 % (CI95%: 93.6 % – 99.9 %) |
Diagnostic Sensitivity | 100% (CI95%: 87.7 % – 100 %) |
Extraction/Inhibition Control |
PCR inhibition and DNA extraction efficiency control |
Validated Specimen | Swab (cervical, vaginal and penile), LBC medium NOVAPREP (Novacyte), SurePath (BD), Self-sampling device FLOQSwab® (COPAN), Evalyn® Brush (Rovers Medical Devices) |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX, Cy5, Texas Red, Cy5.5 |
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 |
+420 543 211 679
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