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GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codestechnical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit VZV/MC/205 PCR for 180 quantitative tests

EQA Panels

EQA results

; GP_MC_VZV_QCMD_01_22_EN
pdf, [222.48 kB]
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Technical specification

Indication in vitro diagnostic medical device
Regulatory Status  CE IVD / EC Directive 98/79/EC
Intended User For professional use in laboratories with trained staff
Test Principle Real-time polymerase chain reaction (PCR)
Type of Analysis Qualitative and quantitative
Automated / Manual detection Automated
Target sequence ORF62 gene 
Analytical Specificity Varicella-Zoster virus (VZV), 100 %
Analytical Sensitivity (LoD with 95% Probability) 155.09 cp/ml
Linear Range 109 – 102.5 cp/ml with precision of ± 0.5 log
Dynamic Range 109 – 155.09 cp/ml
Trueness 0.09 log (CI95%: -0.02 – 0.20) of expected concentration
Precision - repeatability • Intra-assay
SD of log concentration = 0.162 (CI95%: 0.109 – 0.309)
Precision - reproducibility • Inter-assay
SD of log concentration = 0.224 (CI95%: 0.127 – 1.529)
• Inter-device
SD of log concentration = 0.201 (CI95%: 0.105 – 1.259)
• Total
SD of log concentration = 0.198 (CI95%: 0.103 – 1.242)
Reporting Units cp/ml
Metrological Traceability AcroMetrix VZV Plasma Panel
Extraction/Inhibition Control

myCROBE Universal Internal Control

Validated Specimen Plasma, whole blood (EDTA), CSF
Storage -20 ± 5 °C
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM (VZV), HEX (IC)
External Quality Assessment Regularly tested in QCMD External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

; GP_MC_VZV_Instruction_for_Use_EN
pdf, [279.55 kB]

Declaration of Conformity

; GP_MC_VZV_Declaration_of_Conformity_EN
pdf, [610.4 kB]
Files are available only for registered users.

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