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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

EQA Panels

EQA results

; GP_MC_HHV6_QCMD_01_22_EN
pdf, [195.39 kB]
; GP_HHV67_QCMD_06_22_EN_01
pdf, [222.92 kB]
Choose all

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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