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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/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device | ||||||||||||||||||||||||||||||||||||
Regulatory Status | CE IVD | ||||||||||||||||||||||||||||||||||||
Intended User | For professional use in laboratories with trained staff | ||||||||||||||||||||||||||||||||||||
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 |
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Analytical Sensitivity (LoD with 95% probability) |
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Diagnostic Specificity | 99 % (CI95%: 93.6 % – 99.9 %) | ||||||||||||||||||||||||||||||||||||
Diagnostic Sensitivity | 100% (CI95%: 87.7 % – 100 %) | ||||||||||||||||||||||||||||||||||||
Extraction/Inhibition Control |
Proper sampling, DNA extraction efficiency and PCR inhibition control by endogenous Internal control (GAPDH gene) |
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Validated Specimen | Cervical, vaginal and penile swab (transport medium: LBC medium NOVAPREP (Novacyte); SurePath (BD) Self-sampling device FLOQSwab (COPAN); Evalyn® Brush (Rovers medical)) | ||||||||||||||||||||||||||||||||||||
Storage | -20 ± 5 °C | ||||||||||||||||||||||||||||||||||||
Validated Extraction Methods |
croBEE 201A Nucleic Acid Extraction Kit |
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Instruments | croBEE Real-Time PCR System AMPLilab Real-Time PCR System(detection of high-risk HPV with differentiation of HPV 16 and HPV 18) Applied Biosystems 7500 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18) AriaMx Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18) CFX Connect™ Real-Time PCR Detection System (detection of high-risk HPV without differentiation) CFX96™/Dx Real-Time PCR Detection System Gentier 96E/96R Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18) LightCycler® 480 (detection of high-risk HPV without differentiation) LineGene 9600 Plus QuantStudio™ 3 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 18) QuantStudio™ 5 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18) Rotor-Gene Q (detection of high-risk HPV and presence HPV18, 16, and 45 but it does not distinguish coinfection of types 16, 18 and 45 respect to the crosstalk between the channels TexRed/Cy5 and Cy5/Cy5.5) SLAN® Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16) Stratagene Mx3005p qPCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18) |
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Detection Channels | FAM (HPV HR), HEX/JOE/VIC (IC), Cy5 (HPV 16), Texas Red/ROX (HPV 18), Cy5.5/Quasar 705 (HPV 45) | ||||||||||||||||||||||||||||||||||||
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
+420 543 211 679
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…