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GeneProof Gardnerella vaginalis PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

COMPLETE SOLUTION FOR STI

  • As a part of STI Panel enables a comprehensive solution for symptomatic STI diagnostics 
  • Suitable especial for differential diagnostics of non-candidal vulvovaginitis

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other PCR kits from the STI Panel in one workflow

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

  • 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 Gardnerella vaginalis PCR Kit GV/GP/025 real-time PCR 25 reactions
GeneProof Gardnerella vaginalis PCR Kit GV/GP/100 real-time PCR 100 reactions

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
Target Sequence

tuf gene for transcription elongation factor

Analytical Specificity

Gardnerella vaginalis, 100 %

Analytical Sensitivity (LoD)

0,82 cp/µl (performed on AmpliRun® GVA DNA control, Vircell)

Diagnostic Specificity 93.33 % (CI95%: 86.28 % - 97.05 %) 
Diagnostic Sensitivity 100.00 % (CI95%: 91.73 % - 100.00 %) 
Positive Predictive Value 88.52 % (CI95%: 77.17% - 94.88 %) 
Negative Predictive Value 100.00 % (CI95%: 95.30 % - 100.00 %) 
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Control
Validated Specimen swab, urine
Storage -20 ± 5 °C
Validated Extraction Methods

croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

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 detection system
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System 
Gentier 96E/96R Real-Time PCR System
LightCycler® 480
Line Gene 9600 Plus
Rotor-Gene 3000 / 6000 / Q

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_GV_Instruction_for_Use_EN
pdf, [284.18 kB]
; GP_GV_Instruction_for_Use_FR
pdf, [113.97 kB]

Declaration of Conformity

; GP_GV_Declaration_of_Conformity_EN
pdf, [598.31 kB]

MSDS

; GP_GV_Safety_Data_Sheet_EN
pdf, [275.3 kB]

Product Leaflet

; GP_GV_Leaflet_EN
pdf, [122.61 kB]
Files are available only for registered users.