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
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 panelsresults at www.geneproof.com
Certification CE IVD for in vitro Diagnostics Use

*Validated Instruments

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