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GeneProof Treponema pallidum PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGHLY SPECIFIC DETECTION

  • Secured by highly conservative polA gene for DNA polymerase I

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 Treponema pallidum PCR Kit TP/GP/025 real-time PCR 25 reactions
GeneProof Treponema pallidum PCR Kit TP/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_TP_QCMD_12_21_EN_02
pdf, [146.76 kB]
; GP_TP_QCMD_12_21_EN_01
pdf, [145.88 kB]
; GP_TP_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
Technology Real-time PCR
Type of Analysis Qualitative
Target sequence Gene polA encoding DNA polymerase I
Analytical Specificity Treponema pallidum, 100 %
Analytical Sensitivity (LoD with 95% probability)

0.61 cp/μl (on synthetic DNA ultramer Control Treponema pallidum)

Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control 

Validated Specimen Swab from genital ulcer, urine, transport medium: UTM® Viral Transport* (COPAN Diagnostics Inc.)
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A 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
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler ® 480
LineGene 9600 Plus
Mic qPCR Cycler
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOne Plus™ Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com

* UTM® Viral Transport is validated only in combination with croBEE 201A Nucleic Acid Extraction System

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_TP_Instruction for Use_EN
pdf, [277.84 kB]
; GP_TP_Instruction_for_Use_FR
pdf, [113.22 kB]

Declaration of Conformity

; GP_TP_Declaration_of_Conformity_EN
pdf, [552.73 kB]

MSDS

; GP_TP_Safety_Data_Sheet_EN
pdf, [274.97 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_Treponema pallidum_Mic
micassay, [22 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_TP_Leaflet_EN
pdf, [121.57 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.