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GeneProof Trichomonas vaginalis PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGH SPECIFICITY

  • Secured by a multicopy sequence of the beta-tubulin gene
  • Ensures excellent sensitivity reaches up to 0.25 cp/μl

RELIABLE DETECTION 

  • Simple sensitive detection compared to wet mount microscopy and culture

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

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Trichomonas vaginalis PCR Kit TV/GP/025 real-time PCR 25 reactions
GeneProof Trichomonas vaginalis PCR Kit TV/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_TV_QCMD_09_21_EN_02
pdf, [159.97 kB]
; GP_TV_QCMD_09_21_EN_01
pdf, [160.79 kB]
; GP_TV_Instand_06_21_EN
pdf, [901.27 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
Test Principle Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection
Type of Analysis Qualitative
Target Sequence Beta-tubulin gene
Analytical Specificity Trichomonas vaginalis (TV), 100 %
Analytical Sensitivity
(LoD with 95% probability)

0,25 cp/μl (on AmpliRun® Trichomonas vaginalis DNA control, Vircell)

Diagnostic Specificity 98,21 % (CI95%: 89.19 % - 99,91 %)
Diagnostic Sensitivity 100,00 % (CI95%: 87.68 % - 100,00 %)
Positive Predictive Value 97,22 % (CI95%: 83.80 % - 99,85 %)
Negative Predictive Value 100,00 % (CI95%: 91.87 % - 100,00 %)
Extraction/Inhibition Control

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

Validated Specimen Swab (transport medium: UTM® Viral Transport, eNATTM, both from COPAN Diagnostics Inc.), urine
Storage Conditions -20 ± 5 °C
Validated Extraction Methods

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

Applied Instruments croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LightCycler ® 480
LineGene 9600 Plus
Mic qPCR Cycler
QuantStudioTM 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOne Plus™ Real-Time PCR System
Detection Channels FAM (TV), 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, [1.6 MB]
; GP_TV_Instruction for Use_EN
pdf, [289.37 kB]
; GP_TV_Instruction_for_Use_FR
pdf, [106.95 kB]

Declaration of Conformity

; GP_TV_Declaration of Conformity_EN
pdf, [311.8 kB]

MSDS

; GP_TV_Safety_Data_Sheet_EN
pdf, [274.81 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 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_Trichomonas vaginalis_Mic
micassay, [21.94 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_TV_Leaflet_EN
pdf, [129.38 kB]

Manual

; 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]
; 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.