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GeneProof Treponema pallidum MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codestechnical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof Treponema pallidum MC PCR Kit TP/MC/190 PCR for 180 quantitative tests

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD / EC Directive 98/79/EC
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)
Diagnostic Specificity 100,00 % (CI95%: 19.79 % - 100,00 %)
Diagnostic Sensitivity 100,00 % (CI95%: 73.24 % - 100,00 %)
Positive Predictive Value 100,00 % (CI95%: 73.24 % - 100,00 %)
Negative Predictive Value 100,00 % (CI95%: 19.79 % - 100,00 %)
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Control (IC)
Validated Specimen

Swab from genital ulcer (transport medium: UTM® Viral Transport*, COPAN Diagnostics Inc.), urine

Storage Conditions

(-20 ± 5) °C

Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
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® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

Detection Channels FAM (TP), 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

GP_MC_TP_Instruction for use_EN
pdf, [268.92 kB]

Declaration of Conformity

GP_MC_TP_Declaration of conformity_EN
pdf, [561.37 kB]
Files are available only for registered users.

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