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GeneProof BK/JC Virus (BK/JC) PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION FROM ONE REACTION

  • Detects and distinguishes BK virus and JC virus in a single reaction tube
  • Enables qualitative and quantitative detection of both viruses

CONTAMINATION PREVENTION

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

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits

EASY-TO-USE CONCEPT

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

 

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/JC Virus (BK/JC) PCR Kit BKJC/ISEX/025 real-time PCR 25 reactions
GeneProof BK/JC Virus (BK/JC) PCR Kit BKJC/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_BKJC_QCMD_06_22_EN_02
pdf, [228.28 kB]
; GP_BKJC_QCMD_06_22_EN_01
pdf, [228.4 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 (BKV) and t-Ag gene encoding small tumor antigen (JCV)
Analytical Specificity

BK virus, 100 %
JC virus, 100 %

Analytical Sensitivity (LoD with 95% probability)

Sample Processing BKV JCV
GeneProof PathogenFree DNA Isolation Kit 218.73 IU/ml 22.89 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 522.70 IU/ml 56.56 IU/ml
Diagnostic Specificity 100.00 % (BKV: CI95%: 67.85 % - 100.00 %; JCV: CI95%: 95.45 % - 100.00 %)
Diagnostic Sensitivity 100.00 % (BKV: CI95%: 84.50 % - 100.00 %; JCV: CI95%: 98.65 % - 100.00 %)
Positive Predictive Value 100.00 % (BKV: CI95%: 67.85 % - 100.00 %; JCV: CI95%: 95.45 % - 100.00 %)
Negative Predictive Value 100.00 % (BKV: CI95%: 84.50 % - 100.00 %; JCV: CI95%: 98.65 % - 100.00 %)
Linear Range
Extraction method Precision BKV JCV
GeneProof PathogenFree DNA Isolation Kit ± 0.5 log (1010 – 103) IU/ml (1010 - 102) IU/ml
croBEE 201A Nucleic Acid Extraction Kit ± 0.5 log (1010 – 103) IU/ml (1010 - 102) IU/ml
Dynamic Range 1010 IU/ml – LoD (LoD varying according to the extraction)
Trueness
(of expected concentration)
Extraction method BKV JCV
GeneProof PathogenFree DNA Isolation Kit -0.13 log
(CI95%: -0.18 – -0.09)
0.01 log
(CI95%: -0.07 – 0.08)
croBEE 201A Nucleic Acid Extraction Kit -0.16 log
(CI95%: -0.23 – -0.10)
0.01 log
(CI95%: -0.08 – 0.10)
Precision – repeatability • Intra-assay
FAM: SD of log concentration = 0.046 (CI95%: 0.037 - 0.061)
Cy5: SD of log concentration = 0.046 (CI95%: 0.037 - 0.060)
Precision – reproducibility • Inter-assay
FAM: SD of log concentration = 0.044 (CI95%: 0.028 - 0.097)
Cy5: SD of log concentration = 0.046 (CI95%: 0.030 - 0.101)
• Inter-lot
FAM: SD of log concentration = 0.053 (CI95%: 0.034 - 0.116)
Cy5: SD of log concentration = 0.055 (CI95%: 0.036 - 0.122)
• Total
FAM: SD of log concentration = 0.050 (CI95%: 0.032 - 0.111)
Cy5: SD of log concentration = 0.053 (CI95%: 0.034 - 0.116)
Reporting Units IU/ml
Metrological Traceability

1st WHO International Standard for BK Virus DNA (NIBSC code 14/212)
1st WHO International Standard for JC Virus DNA (NIBSC code 14/114)

Extraction / Inhibition Control

PCR inhibition and DNA extraction efficiency control by Internal Control (IC)

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

croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
myCROBE/croBEE 2.0 Universal Extraction Kit

Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 480
LineGene 9600 / 9600 Plus
QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

Required Detection Channels FAM (JCV), Cy5 (BKV), HEX/JOE/VIC (IC)
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_BKJC_Advisory_Notice_07_22_EN
pdf, [1.42 MB]
; GP_BKJC_Advisory_Notice_09_22_EN
pdf, [413.27 kB]
; GP_BKJC_Instruction_for_Use_EN
pdf, [167.74 kB]
; GP_BKJC_Instruction_for_Use_ES
pdf, [169.22 kB]
; GP_BKJC_Instruction_for_Use_FR
pdf, [166.57 kB]
; GP_BKJC_Instruction_for_Use_IT
pdf, [169.23 kB]

Declaration of Conformity

; GP_BKJC_Declaration_of_Conformity_EN
pdf, [593.84 kB]

MSDS

; GP_BKJC_Safety_Data_Sheet_EN
pdf, [277.31 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_BKJC_Leaflet_EN
pdf, [229.72 kB]
; GP_IT_Panel_Leaflet_EN
pdf, [275.02 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.