GeneProof HIV type 1 (HIV-1) PCR Kit
Kat.: HIV/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
HIV A – D, AE, F, AG-GH, N Csoport, O Csoport, BF, H, K, CRF03_AB genotípus detektálására alkalmas, ‘Ready-To-Use’ master mix. (25 reakció)
Leírás
PRODUCT ADVANTAGES
HIGH DIAGNOSTIC SPECIFICITY AND SENSITIVITY
- Diagnostic sensitivity was verified on 128 HIV positive plasma samples acquired from Centre for AIDS Reagents (CFAR), National Institute for Biological Standards and Control (NIBSC)
- Diagnostic specificity was verified on 500 HIV negative samples
DUAL TARGET DETECTION
- Dual targeting prevents detection failure caused by possible mutations inside the HIV-1 genome
DETECTS A BROAD SPECTRUM OF HIV-1 SUBTYPES
- HIV genotypes A – D, AE, F, AG-GH, Group N, Group O, BF, H, K, CRF03_AB
SINGLE TUBE READY-TO-USE MASTER MIX
- Contains all components for PCR amplification
- No additional PCR reagents pipetting necessary
- Reduces the need for qualified laboratory staff
- Ensures reproducibility of the result
CONTROL OF THE WHOLE DIAGNOSTIC PROCESS
- RNA extraction, reverse transcription and PCR amplification
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| Technology | real-time PCR |
| Type of Analysis | qualitative and quantitative |
| Target Sequence | LTR sequence and GaG gene |
| Analytical Specificity | HIV genotypes A – D, AE, F, AG-GH, Group N, Group O, BF, H, K, CRF03_AB, 100% |
| Analytical Sensitivity (LOD) | reaches up to 273.971 IU/ml i.e. 153.424 cp/ml with the probability of 95 % (on HIV-1 NIBSC 16/194 using manual extraction GeneProof PathogenFree RNA Isolation Kit) reaches up to 548.121 IU/ml i.e. 306.948 cp/ml with the probability of 95 % (on HIV-1 NIBSC 16/194 using automatic extractor croBEE NA16 Nucleic Acid Extraction System) reaches up to 98.59 IU/ml i.e. 55.21 cp/ml with the probability of 95 % (on Acrometrix HIV-1 Panel IU/ml using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution) |
| Diagnostic Specificity | 100 % (CI95 % : 99.10 % – 100 %) |
| Diagnostic Sensitivity | 93.66 % (CI95 % : 87.96 % – 96.88 %) |
| Linear Range | 109– 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree RNA Isolation Kit) 109– 103 IU/ml with precision of ± 0.5 log (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Dynamic Range | 109 – 273.971 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit) 109 – 548.121 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Reporting Units | IU/μl |
| Conversion Factor | 1 IU = 0.56 cp |
| Metrological Traceability | HIV NIBSC 16/194 |
| Extraction/Inhibition Control | PCR inhibition and RNA extraction efficiency control (ISEX version) |
| Validated Specimen | plasma |
| Storage | -20 ± 5 °C |
| Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree RNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 3 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
| Regulatory Status | CE1023 IVD |
