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GeneProof Team
The highest possible diagnostic sensitivity (100.00%) and diagnostic specificity (97.44%)
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible carryover contamination
Product name | Catalog no. | Technology | Packaging |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISEX/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 |
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Type of Analysis |
Qualitative and quantitative |
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Target Sequence |
Gene ORF62 |
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Analytical Specificity |
Varicella-zoster virus (VZV), 100% |
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Analytical Sensitivity (LoD) |
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Diagnostic Specificity | 97.44 % (CI95%: 84.92 % - 99.87 %) | |||||||||||||||
Diagnostic Sensitivity | 100.00 % (CI95%: 97.52 % - 100.00 %) | |||||||||||||||
Positive Predictive Value | 99.47 % (CI95%: 96.65 % - 99.97 %) | |||||||||||||||
Negative Predictive Value | 100.00 % (CI95%: 88.57 % - 100.00 %) | |||||||||||||||
Linear Range |
1010 – 102.5 cp/ml with precision of ± 0.8 log |
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Dynamic Range | 1010 – LoD cp/ml (LoD varying according to the extraction and material used) | |||||||||||||||
Precision - Repeatability | • Intra-assay SD of log concentration = 0.076 (CI95%: 0.061 – 0.099) | |||||||||||||||
Precision - Reproducibility |
• Inter-assay SD of log concentration = 0.079 (CI95%: 0.051 – 0.174) • Inter-lot SD of log concentration = 0.081 (CI95%: 0.052 – 0.177) • Total SD of log concentration = 0.081 (CI95%: 0.052 – 0.179) |
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Trueness (of expected concentration) |
-0.01 log (CI95%: -0.15 – 0.14) using manual extraction GeneProof PathogenFree DNA Isolation Kit -0.07 log (CI95%: -0.15 – 0.00) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit |
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Reporting Units |
cp/ml |
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Metrological Traceability |
AcroMetrixTM VZV Plasma Panel (cat. no. 954530) |
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Extraction/Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) |
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Validated Specimen |
CSF, plasma, serum, whole blood (EDTA), vesicular swab | |||||||||||||||
Storage |
-20 ± 5 °C |
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Validated Extraction Method |
croBEE 201A Nucleic Acid Extraction System |
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Instruments |
croBEE Real-Time PCR System |
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Required Detection Channels |
FAM (VZV), HEX/JOE/VIC (IS) |
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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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+420 730 176 222
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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…