GeneProof MRSA PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for methicillin-resistant Staphylococcus aureus detection by the real-time Polymerase Chain Reaction (PCR) method.
The MRSA detection consists in amplification of three specific loci (the nuc gene which is specific for Staphylococcus aureus, the SCCmec/orfX junction region and the resistance genes mecA/mecC) and in measurement of fluorescence increase. The nuc gene presence is indicated by the TEX fluorophore fluorescence growth. The SCCmec/orfX junction presence is indicated by the FAM fluorophore fluorescence growth. The resistance gene mecA/mecC presence is indicated by the Cy5 fluorophore fluorescence growth. 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 by 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 | nuc gene, which is specific for Stapholococcus aureus
SCCmec/orfX junction region resistance gene mecA/mecC |
| Specificity | Methicillin-Resistant Staphylococcus aureus (MRSA) |
| Sensitivity (LoD) | reaches up to 2.81 ge/µl with the probability of 95 % (on NCTC strain 13142) |
| Extraction/Inhibition Control | PCR Inhibition control (ISIN version)
PCR Inhibition and DNA extraction efficiency control (ISEX version) |
| Validated specimen | aspirate, sputum, swab, urine |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Validated Instruments | croBEE Real-Time PCR System Applied Biosystems 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX96™ / Dx Real-Time PCR Detection System LineGene 9600 / 9600 Plus QuantStudio™ 5 Real-Time PCR System Rotor-Gene 3000 / Q |
| Required Detection Channels | FAM, HEX, Cy5, Texas Red |
| Quality Control | quality management system is certified in compliance with the requirements of the standard ISO 13485 |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.com |
| Certification | CE IVD for in vitro Diagnostics Use |
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof MRSA PCR Kit | MRSA/ISEX/025 | real-time PCR | 025 |
| GeneProof MRSA PCR Kit | MRSA/ISEX/050 | real-time PCR | 050 |
| GeneProof MRSA PCR Kit | MRSA/ISEX/100 | real-time PCR | 100 |