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GeneProof BK Virus (BKV) PCR Kit

CE IVD New product GP line

PRODUCT ADVANTAGES

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to 1st WHO International Standard NIBSC BKV 14/212
  • Enables reliable viral load monitoring

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof BK Virus (BKV) PCR Kit BKV/GP/025 real-time PCR 25 reaction
GeneProof BK Virus (BKV) PCR Kit BKV/GP/100 real-time PCR 100 reaction

EQA Panels

EQA results

; GP_BKV_QCMD_06_22_EN
pdf, [226.5 kB]
; GP_BKV_Instand_03_22_EN
pdf, [1.06 MB]
; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 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
Technology real-time PCR
Type of Analysis qualitative and quantitative
Target Sequence T-Ag gene encoding large tumor antigen
Analytical Specificity BK virus (BKV), 100 %

Analytical Sensitivity (LoD with 95% probability) 

Sample Processing CSF Plasma Whole blood
GeneProof PathogenFree DNA Isolation Kit 240.9 IU/ml 297.0 IU/ml 251.8 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 532.1 IU/ml 644.7 IU/ml 908.6 IU/ml
Diagnosis Specificity

100.00 % (CI95%: 86.27 % – 100.00 %)

Diagnosis Sensitivity 96.30 % (CI95%: 79.11 % – 99.81 %)
Positive Predictive Value 100.00 % (CI95%: 83.98 % – 100.00 %)
Negative Predictive Value 96.88 % (CI95%: 82.00 % – 99.84 %)
Linear Range 1010 – 103 IU/ml with precision of ± 0.5 log (using manual or automatic extraction from plasma, CSF
and whole blood)
Dynamic Range 1010 – LoD IU/ml (LoD varying according to the extraction and material used)
Trueness (of expected concentration)
Extraction Method CSF Plasma Whole blood
GeneProof PathogenFree DNA Isolation Kit -0.11 log
(CI95%: -0.20 – -0.02)
-0.07 log
(CI95%: -0.14 – -0.01)
-0.04 log
(CI95%: -0.14 – -0.01)
croBEE 201A Nucleic Acid Extraction Kit -0.12 log
(CI95%: -0.23 – -0.01)
-0.06 log
(CI95%: -0.12 – 0.00)
-0.07 log
(CI95%: -0.15 – 0.00)
Precision – Repeatability Intra-assay SD of log concentration = 0.061 (CI95%: 0.050 – 0.080)
Precision – Reproducibility Inter-assay SD of log concentration = 0.112 (CI95%: 0.072 – 0.246)
Inter-lot SD of log concentration = 0.206 (CI95%: 0.133 – 0.454)
Total SD of log concentration = 0.243 (CI95%: 0.157 – 0.536)
Reporting Units IU/ml
Conversion Factor 1 IU = 1 cp
Metrological Traceability 1st WHO International Standard for BK virus DNA (NIBSC code 14/212)
Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control by Internal Control

Validated Specimen CSF, plasma, urine, whole blood
Storage -20 ± 5 °C

Validated Extraction Methods

croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Validated Instruments

croBEE Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AMPLilab Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
Gentier 96E/96R Real-Time PCR System
Mic qPCR Cycler
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX/JOE
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_BKV_Advisory_Notice_05_22_EN
pdf, [466.91 kB]
; GP_BKV_Instruction_for_Use_EN
pdf, [346.28 kB]
; GP_BKV_Instruction_for_Use_FR
pdf, [198.52 kB]

Declaration of Conformity

; GP_BKV_Declaration_of_conformity_EN
pdf, [619.9 kB]

MSDS

; GP_BKV_Safety_Data_Sheet_EN
pdf, [276.42 kB]

Product Leaflet

; GP_BKV_Leaflet_EN
pdf, [118.26 kB]
; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 kB]
Files are available only for registered users.