ESBL Resistance Detection

Test Overview

TRUPCR® ESBL Resistance Detection Kit is an in vitro nucleic acid amplification assay for sensitive and specific detection and differentiation of Extended-Spectrum Bela-Lactam (ESBL) resistance mediated by bla_{CTX-M gr1}, bla_TEM, and/or bla_SHV gene(s) in clinical samples / cultured isolates using real-time PCR. ESBL is often used to treat severe infections caused by multidrug-resistant Gram-negative bacteria.

An Endogenous Internal Control is incorporated into the kit to verify the quality of samples, quality of extracted DNA, amplification procedure and possible presence of inhibitors, which may cause false negative results and this design, makes this kit highly reliable.

This is a single tube assay which can detect bla_{CTX-M gr1} in FAM/Green channel, bla_TEM in Texas Red/ROX/Orange channel, bla_SHV in Cy5/Red channel and endogenous internal control in HEX/VIC/Yellow channel.

TECHNICAL SPECIFICATIONS

• Sample Type – Extracted DNA from Clinical samples/cultured isolates
• Target Regions – Conserved region of blaCTX-M gr1, blaTEM and blaSHV genes
• Clinical Validation – Validated on more than 500 clinical samples
• LoD: 10 Copies/reaction
• Reaction Volume – 20 µl
• Compatible Instruments – Applied Biosystems™ 7500 series, Applied Biosystems™ QuantStudio® 5, Rotor-Gene Q, Bio-Rad CFX96

About ESBL Resistance:

Extended-spectrum β-lactamase (ESBL)-producing Gram-negative pathogens are a major cause of resistance to expanded-spectrum β-lactam antibiotics. Since their discovery in the early 1980s, they have spread worldwide and an are now endemic in Enterobacterales isolated from both hospital-associated and community-acquired infections. As a result, they are a global public health concern. Unfortunately, when ESBLs are not identified in a timely manner, appropriate antimicrobial therapy is frequently delayed, resulting in poor clinical outcomes.

Culture is the reference method for detection, requires at least a turn-around time of between 2-3 days which will be critical in emergency and ICU patients when the time available for intervention is limited. New CLSI recommendations aim to speed up detection and improve treatment outcomes for ESBL resistance through use of a molecular diagnostic test.