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GeneProof Cytomegalovirus (CMV) MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codes, technical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof Cytomegalovirus (CMV) MC PCR Kit CMV/MC/205 PCR 180 kvantitativních testů

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status  CE1023IVD / 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 4 IE antigen gene
Analytical Specificity Human Cytomegalovirus, 100 %
Analytical Sensitivity (LoD with 95% Probability) 297.27 IU/ml
Linear Range 109 – 103 IU/ml with precision of ± 0.5 log
Dynamic Range 109 – 297.27 IU/ml
Trueness 0.10 log (CI95%: 0.02– 0.19) of expected concentration
Precision - repeatability • Intra-assay
SD of log concentration = 0.151 (CI95%: 0.102 – 0.290)
Precision - reproducibility • Inter-assay
SD of log concentration = 0.229 (CI95%: 0.119 – 1.433)
• Inter-device
SD of log concentration = 0.183 (CI95%: 0.096 – 1.149)
• Total
SD of log concentration = 0.248 (CI95%: 0.129 – 1.552)
Reporting Units IU/ml and cp/ml
Metrological Traceability CMV NIBSC 09/162 (1st WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques)
Extraction/Inhibition Control

myCROBE Universal Internal Control

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

myCROBE® Fully Automated Instrument

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


Instruction for Use

pdf, [251.54 kB]
Files are available only for registered users.


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