GeneProof Ureaplasma PCR Kit

GeneProof Ureaplasma PCR Kit



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

The U. parvum and U. urealyticum detection and differentiation consist in amplification of a conservative sequence of UreD gene and in measurement of fluorescence increase. The U. parvum presence is indicated by the FAM fluorophore fluorescence growth only. The U. urealyticum presence is indicated by the fluorescence growth in both FAM and Cy5 channels. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.


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

Validated 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 PlusMic qPCR CyclerQuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System2-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
Certification CE IVD for in vitro diagnostics


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

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