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GeneProof® HIV type 1 (HIV-1) Diagnostic PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
DUAL TARGET DETECTION
• Protection against detection failures caused by virus mutations
QUALITATIVE AND QUANTITATIVE DETECTION
• Monitoring of pathogen level in time
• Full traceability to WHO standard
EASY-TO-USE CONCEPT
• Single tube Ready-to-Use Master Mix contains all components for PCR amplification
• No additional PCR reagents pipetting necessary
CONTAMINATION PREVENTION
• Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CERTIFIED DIAGNOSTIC TEST
HIV1D/GP/025 – 25 tests
HIV1D/GP/100 – 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| INTENDED USER | For professional use in laboratories with trained staf |
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | HIV subtypes A – D, AE, F, G, AG-GH, BF, H, K, CRF03_AB, Group N, Group O – 100 % |
| DIAGNOSTIC SENSITIVITY | 95.41% (CI95% : 89.10% – 98.30%) |
| NEGATIVE PREDICTIVE VALUE | 100.00% (CI95% : 99.05 % – 100.00%) |
| PRECISION – REPEATABILITY | Intra-assay SD of log concentration = 0.065 (CI95% : 0.052 – 0.085) |
| REPORTING UNITS | IU/ml |
| METROLOGICAL TRACEABILITY | 4th HIV-1 International Standard NIBSC 16/194 |
| VALIDATED SPECIMEN | Plasma (EDTA, citrate), serum |
| INSTRUMENTS | croBEE Real-Time PCR System; Applied Biosystems 7300 / 7500 Real-Time PCR System; AriaMx Real-Time PCR System; BioQuant-96, Fluorescent Quantitative Detection PCR system; CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System; LineGene 9600 Plus; Rotor-Gene 3000 / Q; SLAN® Real-Time PCR System |
| EXTERNAL QUALITY ASSESSMENT | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com |
| REGULATORY STATUS | CE IVD / EU Directive 98/79/EC |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | LTR sequence, gag/pol gene boundary and gag gene |
| DIAGNOSTIC SPECIFICITY | 100.00% (CI95% : 99.05% – 100.00%) |
| POSITIVE PREDICTIVE VALUE | 100.00% (CI95% : 95.56 % – 100.00%) |
| DYNAMIC RANGE | 10*9 IU/ml – LoD (LoD varying according to the extraction and material used) |
| PRECISION – REPRODUCIBILITY | Inter-assay SD of log concentration = 0.083 (CI95% : 0.054 – 0.184); Inter-lot SD of log concentration = 0.076 (CI95% : 0.049 – 0.167); Total SD of log concentration = 0.086 (CI95% : 0.055 – 0.189) |
| CONVERSION FACTOR | 1 IU = 0.55 cp |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition, reverse-transcription efficiency and RNA extraction efficiency control by Internal Control |
| STORAGE | -20 ± 5 °C |
| REQUIRED DETECTION CHANNELS | FAM, HEX/JOE |
Service and Warranty
GENEPROOF CALCULATOR
The on-line calculator was developed by GeneProof to simplify the evaluation of GeneProof quantitative PCR kits.
To access the online calculator, click the button below
If you have any questions, please contact our specialists on the CONTACTS page.
We provide premium service and maintenance for every device and consumable:
• Comprehensive maintenance of medical equipment
• Installations, commissioning
• Warranty and post-warranty service
• Instruction, training and consultations for your team
More details on the SERVICE page
Contacts for communication:
| Contact phone | +38 (067) 120 95 75 |
|---|---|
| E-mail: | service@empirica.healthcare |