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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 Human Herpesvirus 8 (HHV-8) MC PCR Kit||HHV8/MC/205||PCR||for 180 quantitative tests|
|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||ORF26 gene encoding the minor capsid protein (mCP)
ORF73 gene encoding the latency-associated nuclear antigen (LANA)
|Analytical Specificity||Human Herpesvirus 8 (HHV-8), 100 %|
|Analytical Sensitivity (LoD with 95% Probability)||1313.1 cp/ml|
|Linear Range||109 – 103.7 cp/ml with precision of ± 0.5 log|
|Dynamic Range||109 – 1313.1 cp/ml|
|Trueness||0.10 log (CI95%: 0.01– 0.19) of expected concentration|
|Precision - repeatability||• Intra-assay
SD of log concentration = 0.177 (CI95%: 0.120 – 0.339)
|Precision - reproducibility||• Inter-assay
SD of log concentration = 0.139 (CI95%: 0.072 – 0.870)
SD of log concentration = 0.192 (CI95%: 0.100 – 1.199)
SD of log concentration = 0.168 (CI95%: 0.088 – 1.053)
myCROBE Universal Internal Control
|Validated Specimen||Plasma, CSF, whole blood (EDTA)|
|Storage||-20 ± 5 °C|
|Validated Extraction Methods||myCROBE/croBEE 2.0 Universal Extraction Kit|
myCROBE® Fully Automated Instrument
|Detection Channels||FAM (HHV8), HEX (IC)|
|External Quality Assessment||Regularly tested in INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com|
Association between acute, severe hepatitis in small children and Adenovirus infection is currently under…
GeneProof merges with American Laboratory Products Company.