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GeneProof Epstein-Barr Virus (EBV) 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 Epstein-Barr Virus (EBV) MC PCR Kit EBV/MC/205 PCR for 180 quantitative tests

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status  CE IVD
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 EBNA1
Analytical Specificity Epstein-Barr Virus (EBV), 100 %
Analytical Sensitivity (LoD with 95% Probability) 545.24 IU/ml
Linear Range 109 – 103 IU/ml with precision of ± 0.5 log
Dynamic Range 109 – 545.24 IU/ml
Trueness -0.02 log (CI95%: -0.17– 0.13) of expected concentration
Precision - repeatability • Intra-assay
SD of log concentration = 0.165 (CI95%: 0.111 – 0.316)
Precision - reproducibility • Inter-assay
SD of log concentration = 0.173 (CI95%: 0.090 – 1.085)
• Inter-device
SD of log concentration = 0.205 (CI95%: 0.107 – 1.283)
• Total
SD of log concentration = 0.205 (CI95%: 0.107 – 1.284)
Reporting Units IU/ml and cp/ml
Conversion Factor 1 IU = 1 cp
Metrological Traceability EBV NIBSC 09/260 (1st WHO International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques)
Extraction/Inhibition Control

myCROBE Universal Internal Control

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

myCROBE® Fully Automated Instrument

Detection Channels FAM (EBV), HEX (IC)
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

Documentation

Declaration of Conformity

GP_MC_EBV_Declaration_of_Conformity_EN
pdf, [614.99 kB]
Files are available only for registered users.

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