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GeneProof BK Virus (BKV) 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 BK Virus (BKV) MC PCR Kit BKV/MC/205 PCR for 180 quantitative tests

EQA Panels

EQA results

; GP_MC_BKV_QCMD_01_22_EN
pdf, [195.39 kB]
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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 Gen T-Ag
Analytical Specificity BK virus (BKV), 100 %
Analytical Sensitivity (LoD with 95% Probability) 500,1 IU/ml 
Linear Range 109 – 103.2 IU/ml with precision of ± 0.5 log
Dynamic Range 109 – 500.1 IU/ml
Trueness 0.03 log (CI95%: -0.07 – 0.12) of expected concentration
Precision - repeatability • Intra-assay
SD of log concentration = 0.155 (CI95%: 0.104 – 0.296)
Precision - reproducibility • Inter-assay
SD of log concentration = 0.191 (CI95%: 0.100– 1.197)
• Inter-device
SD of log concentration = 0.234 (CI95%: 0.122 – 1.464)
• Total
SD of log concentration = 0.284 (CI95%: 0.148 – 1.781)
Reporting Units IU/ml and cp/ml
Conversion Factor 1 IU = 1 cp
Metrological Traceability BK Virus NIBSC 14/212 (1st WHO International Standard for BK Virus DNA)
Extraction/Inhibition Control

myCROBE Universal Internal Control

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

myCROBE® Fully Automated Instrument

Detection Channels FAM (BKV), HEX (IC)
External Quality Assessment Regularly tested in INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

; GP_MC_BKV_Instruction_for_Use_EN
pdf, [254.03 kB]

Declaration of Conformity

; GP_MC_BKV_Declaration_of_Conformity_EN
pdf, [615.63 kB]
Files are available only for registered users.

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