GeneProof Ureaplasma PCR Kit

CE IVD

 

PRODUCT DETAIL

The PCR kit is designed for Ureaplasma parvum and Ureaplasma urealyticum detection and differentiation by the real-time Polymerase Chain Reaction (PCR) method.

MORE INFORMATION WITH LESS SAMPLES

  • Enables the identification of Ureaplasma urealyticum using 3-channel system

UNIVERSAL PCR PROFILE

  • Easily combinable with other PCR kits from the STI group
  • Simplifies laboratory workflow

CONTAMINATION ELIMINATION

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

 

TECHNICAL SPECIFICATION

Technology real-time PCR
Type of Analysis qualitative
Target Sequence UreD gene
Specificity

U. parvum, 100 %

U. urealyticum, 100 %

Sensitivity (LoD) reaches up to 0.687 cp/μl with the probability 95 % (on Amplirun® Ureaplasma urealyticum DNA control, Vircell)
Extraction/Inhibition Control

PCR inhibition control (ISIN version)

PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen

swab, urine

Storage -20 ± 5 °C
Validated Extraction Methods

croBEE NA16 Nucleic Acid Extraction System

GeneProof PathogenFree DNA Isolation Kit

Instruments

3-channel detection
croBEE Real-Time PCR System*
AriaMx Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 480
LineGene 9600 / 9600 Plus

Mic qPCR Cycler

QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

 

2-channel detection
CFX Connect™ Real-Time PCR System
QuantStudio™ 3 Real-Time PCR System
Rotor-Gene 6000
StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels

3-channel detection: FAM, HEX, Cy5

2-channel detection: FAM, HEX

if a 2-channel system is used, only the presence of Ureaplasma spp. without any further differentiation is detected in the FAM channel

Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment regularly tested by QCMD External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD for in vitro diagnostics

*validated instrument

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Ureaplasma PCR Kit UUP/ISEX/025 real-time PCR 25 reactions
GeneProof Ureaplasma PCR Kit UUP/ISEX/050 real-time PCR 50 reactions
GeneProof Ureaplasma PCR Kit UUP/ISEX/100 real-time PCR 100 reactions