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GeneProof Treponema pallidum PCR Kit

CE IVD New product

PRODUCT ADVANTAGES

 

HIGHLY SPECIFIC DETECTION

  • Secured by highly conservative polA gene for DNA polymerase I

UNIVERSAL PCR PROFILE

  • Simplifies laboratory workflow
  • Easily combinable with other PCR kits from the STI group, especially with GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit
  • Suitable for differential diagnostics of genital ulcer, appearing in the primary stage of syphilis

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

 

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/050 real-time PCR 50 reactions
GeneProof Treponema pallidum PCR Kit TP/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_Instand_06.2020_EN
pdf, [303.08 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target sequence gene polA encoding DNA polymerase I
Analytical Specificity Treponema pallidum, 100 %
Analytical Sensitivity (LoD)

reaches up to 0.61 cp/μl with the probability of 95 % (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 NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

croBEE Real-Time PCR System**
Applied Biosystems 7300 / 7500 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection 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 by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD 

* UTM® Viral Transport is validated only in combination with croBEE NA16 Nucleic Acid Extraction System
** Validated Instrument

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_TP_Instruction for Use_CZ
pdf, [149.51 kB]
GP_TP_Instruction for Use_EN
pdf, [110.57 kB]

Declaration of Conformity

GP_TP_Declaration of Conformity_CZ
pdf, [306.72 kB]
GP_TP_Declaration of Conformity_EN
pdf, [308.72 kB]

MSDS

GP_Safety Data Sheet_CZ
pdf, [134.4 kB]
GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_CZ
pdf, [2.13 MB]
Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_EN
pdf, [2.03 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_CZ
pdf, [3.97 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_EN
pdf, [4.04 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_CZ
pdf, [2.37 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [2.2 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 480/480 Instrument II_CZ
pdf, [2.3 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_CZ
pdf, [4.66 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_CZ
pdf, [2.7 MB]
Mic qPCR Cycler_EN
pdf, [2.6 MB]
Rotor-Gene_3000_6000_Q_CZ
pdf, [2.25 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.59 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_CZ
pdf, [4.37 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]

Product Leaflet

GP_STI_GPacks_Leaflet_EN
pdf, [104.02 kB]
GP_TP_Leaflet_EN
pdf, [165.31 kB]
Files are available only for registered users.