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On this page you will find order codes, technical specifications and documents for the selected product.
|Product name||Catalog no.||Technology||Packaging|
|GeneProof Varicella-Zoster Virus (VZV) MC PCR Kit||VZV/MC/205||PCR||for 180 quantitative tests|
|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)
SD of log concentration = 0.201 (CI95%: 0.105 – 1.259)
SD of log concentration = 0.198 (CI95%: 0.103 – 1.242)
|Metrological Traceability||AcroMetrix VZV Plasma Panel|
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|
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|
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GeneProof merges with American Laboratory Products Company.