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GeneProof JC Virus (JCV) 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 JCV 14/114

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 JC Virus (JCV) PCR Kit JCV/GP/025 real-time PCR 25 reactions
GeneProof JC Virus (JCV) PCR Kit JCV/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_JCV_QCMD_06_22_EN
pdf, [225.24 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 small tumor antigen
Analytical Specificity JC Virus (JCV), 100 %

Analytical Sensitivity (LoD with 95% probability) 

Sample Processing CSF Plasma Whole blood
GeneProof PathogenFree DNA Isolation Kit 8.4 IU/ml 12.6 IU/ml 34.4 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 19.7 IU/ml 40 IU/ml 22.3 IU/ml
Diagnosis Specificity

97.50 % (CI95%: 85.27 % - 99.87 %)

Diagnosis Sensitivity 100.00 % (CI95%: 84.5 % - 100.00 %)
Positive Predictive Value 96.43 % (CI95%: 79.76 % - 99.81 %)
Negative Predictive Value 100.00 % (CI95%: 88.83 % - 100.00 %)
Linear Range
Extraction Method Precision CSF Plasma Whole blood
GeneProof PathogenFree DNA Isolation Kit ± 0.5 log (1010 – 102) IU/ml (1010 – 102) IU/ml (1010 – 102) IU/ml
croBEE 201A Nucleic Acid Extraction Kit ± 0.5 log (1010 – 102) IU/ml (1010  – 102.5) IU/ml (1010 – 102) IU/ml
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 -0.05 log
(CI95%: -0.13 – 0.02)
-0.06 log
(CI95%: -0.14 – 0.02)
-0.09 log
(CI95%: -0.19 – 0.00)
croBEE 201A Nucleic Acid Extraction Kit -0.08 log
(CI95%: -0.16 – 0.00)
-0.03 log
(CI95%: -0.09 – 0.03)
-0.12 log
(CI95%: -0.22 – -0.02)
Precision – Repeatability Intra-assay SD of log concentration = 0.068 (CI95%: 0.055 – 0.089)
Precision – Reproducibility Inter-assay SD of log concentration = 0.078 (CI95%: 0.050 – 0.171)
Inter-lot SD of log concentration = 0.094 (CI95%: 0.061 – 0.208)
Total SD of log concentration = 0.086 (CI95%: 0.055 – 0.190)
Reporting Units IU/ml
Metrological Traceability 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

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
AMPLilab REal-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
Gentier 96E/96R Real Time PCR System
LightCycler® 480AriaMx Real-Time PCR System
LineGene 9600 Plus
Mic qPCR Cycler
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

Required Detection Channels FAM (JCV), HEX/JOE (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_JCV_ Instruction_for_use_EN
pdf, [351 kB]
; GP_JCV_Advisory Notice_EN
pdf, [471.15 kB]
; GP_JCV_Instruction_for_Use_FR
pdf, [194.63 kB]
; GP_JCV_Instruction_for_Use_PT
pdf, [194.12 kB]

Declaration of Conformity

; GP_JCV_Declaration_of_conformity_EN
pdf, [610.23 kB]

MSDS

; GP_JCV_Safety_Data_Sheet_EN
pdf, [276.68 kB]

Product Leaflet

; GP_JCV_Leaflet_EN
pdf, [186.53 kB]
Files are available only for registered users.