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GeneProof Varicella-Zoster Virus (VZV) PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

EXCELLENT QUALITY

  • The highest possible diagnostic sensitivity (100.00%) and diagnostic specificity (97.44%)

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one run

EASY-TO-USE CONCEPT

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

CONTAMINATION PREVENTION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible 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 Varicella-Zoster Virus (VZV) PCR Kit VZV/ISEX/025 real-time PCR 25 reactions
GeneProof Varicella-Zoster Virus (VZV) PCR Kit VZV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_VZV_QCMD_05_22_EN_02
pdf, [144.09 kB]
; GP_VZV_QCMD_05_22_EN_01
pdf, [143.97 kB]
; GP_VZV_QCMD_09_21_EN_02
pdf, [139.48 kB]
; GP_VZV_QCMD_09_21_EN_01
pdf, [139.5 kB]
; GP_VZV_QCMD_06_21_EN_02
pdf, [138.85 kB]
; GP_VZV_QCMD_06_21_EN_01
pdf, [138.8 kB]
; GP_VZV_Instand_06_21_EN
pdf, [1 MB]
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

Gene ORF62

Analytical Specificity

Varicella-zoster virus (VZV), 100%

Analytical Sensitivity (LoD)

Sample Processing Plasma Serum Whole blood CSV
GeneProof PathogenFree DNA Isolation Kit 113,1 cp/ml 66,1 cp/ml 119,9 cp/ml 66,4 cp/ml
croBEE 201A Nucleic Acid Extraction Kit 218,8 cp/ml 166,5 cp/ml 170,4 cp/ml 175,1 cp/ml
Diagnostic Specificity 97.44 % (CI95%: 84.92 % - 99.87 %)
Diagnostic Sensitivity 100.00 % (CI95%: 97.52 % - 100.00 %)
Positive Predictive Value 99.47 % (CI95%: 96.65 % - 99.97 %)
Negative Predictive Value 100.00 % (CI95%: 88.57 % - 100.00 %)

Linear Range

 1010 – 102.5 cp/ml with precision of ± 0.8 log

Dynamic Range 1010 – LoD cp/ml (LoD varying according to the extraction and material used)
Precision - Repeatability • Intra-assay SD of log concentration = 0.076 (CI95%: 0.061 – 0.099)
Precision - Reproducibility

• Inter-assay SD of log concentration = 0.079 (CI95%: 0.051 – 0.174)

• Inter-lot SD of log concentration = 0.081 (CI95%: 0.052 – 0.177)

• Total SD of log concentration = 0.081 (CI95%: 0.052 – 0.179)

Trueness (of expected concentration)

-0.01 log (CI95%: -0.15 – 0.14) using manual extraction GeneProof PathogenFree DNA Isolation Kit

-0.07 log (CI95%: -0.15 – 0.00) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit

Reporting Units

 cp/ml

Metrological Traceability

AcroMetrixTM VZV Plasma Panel (cat. no. 954530)

Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)

Validated Specimen

CSF, plasma, serum, whole blood (EDTA), vesicular swab

Storage

-20 ± 5 °C

Validated Extraction Method

croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

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® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
StepOneTM / StepOne PlusTM Real-Time PCR System
SLAN® Real-Time PCR System

Required Detection Channels

FAM (VZV), HEX/JOE/VIC (IS)

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, [1.6 MB]
; GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
pdf, [508.26 kB]
; GP_VZV_Advisory_Notice_04_22
pdf, [1.01 MB]
; GP_VZV_Instrucciones_de_Uso_ES
pdf, [348.87 kB]
; GP_VZV_Instruction_for_Use_EN
pdf, [363.06 kB]
; GP_VZV_Instruction_for_Use_IT
pdf, [170.99 kB]

Declaration of Conformity

; GP_VZV_Declaration of Conformity_EN
pdf, [581.93 kB]

MSDS

; GP_VZV_Safety_Data_Sheet_EN
pdf, [276.86 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]
; GP_VZV_Mic
micassay, [22.17 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_IT_Panel_Leaflet_EN
pdf, [275.02 kB]
; GP_VZV_Leaflet_EN
pdf, [170.95 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 2.0_EN
pdf, [1.8 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]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.