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GeneProof Team
Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
Product name | Catalog no. | Technology | Packaging |
GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit | HIV1D/GP/025 | real-time PCR | 25 reactions |
GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit | HIV1D/GP/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device | ||||||||||||||||
Regulatory Status | CE1023 IVD | ||||||||||||||||
Intended User | For professional use in laboratories with trained staff | ||||||||||||||||
Technology | Real-time PCR | ||||||||||||||||
Type of Analysis | Qualitative and quantitative | ||||||||||||||||
Target Sequence |
LTR sequence, gag/pol gene boundary and gag gene |
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Analytical Specificity |
HIV subtypes A – D, AE, F, G, AG-GH, BF, H, K, CRF03_AB, Group N, Group O – 100 % |
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Analytical Sensitivity (LoD with 95% probability) |
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Diagnostic Specificity | 100 % (CI95% : 99.05 % - 100 %) | ||||||||||||||||
Diagnostic Sensitivity |
95.41 % (CI95% : 89.10 % - 98.30 %) |
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Positive Predictive Value | 100 % (CI95% : 95.56 % - 100.00 %) | ||||||||||||||||
Negative Predictive Value | 100 % (CI95% : 99.05 % - 100.00 %) | ||||||||||||||||
Linear Range |
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Dynamic Range |
109 IU/ml – LoD (LoD varying according to the extraction and material used) |
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Trueness |
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Precision – Repeatability | Intra-assay SD of log concentration = 0.065 (CI95%: 0.052 – 0.085) | ||||||||||||||||
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) |
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Reporting Units |
IU/μl |
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Conversion Factor |
1 IU = 0.55 cp |
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Metrological Traceability | 4th HIV-1 International Standard NIBSC 16/194 | ||||||||||||||||
Extraction/Inhibition Control | PCR inhibition, reverse-transcription efficiency and RNA extraction efficiency control by Internal Control | ||||||||||||||||
Validated Specimen | plasma (EDTA, citrate), serum | ||||||||||||||||
Storage | -20 ± 5 °C | ||||||||||||||||
Validated Extraction Method | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree RNA Isolation Kit MagCore Automated NA Extractor |
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Instruments |
croBEE Real-Time PCR System |
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Required Detection Channels | FAM, HEX/JOE | ||||||||||||||||
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels - results at www.geneproof.com |
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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…