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GeneProof Human Herpesvirus 6/7 (HHV-6/7) 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 Human Herpesvirus 6/7 (HHV-6/7) MC PCR Kit HHV/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 U94 for HHV-6, U57 for HHV-7
Analytical Specificity Human Herpesvirus 6 and 7 (HHV-6/7), 100 %
Analytical Sensitivity (LoD with 95% Probability) 196.53 IU/ml
Linear Range 109 – 103 IU/ml with precision of ± 0.5 log
Dynamic Range 109 – 196.53 IU/ml
Trueness 0.04 log (CI95%: -0.05 – 0.12) of expected concentration
Precision - repeatability • Intra-assay
SD of log concentration = 0.103 (CI95%: 0.069 – 0.197)
Precision - reproducibility • Inter-assay
SD of log concentration = 0.186 (CI95%: 0.097 – 1.165)
• Inter-device
SD of log concentration = 0.207 (CI95%: 0.108 – 1.293)
• Total
SD of log concentration = 0.188 (CI95%: 0.098 – 1.178)
Reporting Units IU/ml
Metrological Traceability HHV6B NIBSC 15/266
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
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM (HHV-6), Cy5 (HHV-7)*, HEX (Internal control)
External Quality Assessment Regularly tested in INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com
 
* NOTE: Due to the availability of international reference standard only for HHV-6, it is possible to monitor HHV-7 without metrological traceability.
Quantitative parameters were determined on plasma samples.

Documentation

Instruction for Use

GP_MC_HHV_Instruction_for_Use_EN
pdf, [283.33 kB]

Declaration of Conformity

GP_MC_HHV-6_7_Declaration_of_Conformity_EN
pdf, [633.52 kB]
Files are available only for registered users.

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