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.
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.
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 |
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 www.geneproof.com |
Certification | CE IVD for in vitro diagnostics |
ORDER INFORMATION
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 |