Co-Dx™ Logix Smart® Mycobacteria Tuberculosis (MTB) test kit
Boost speed and accuracy with real-time PCR testing
How it works
The test uses real-time PCR to amplify the IS6110 and MPB64 regions of the pathogen genome. The amplified product is then detected by fluorescent dyes (FAM, CF560, and CF610).
Test kit components
Ready-to-use Master Mix
Includes the complete mix for convenience and an Internal Positive Control (IPC) - Human RNaseP gene marker
Positive Control
Synthetic control intended to amplify all targets included in the kit to ensure integrity of the entire run
Negative Control
Acts as a negative control to verify Master Mix is free from contamination
Additional information
The Co-Dx Logix Smart MTB test kit is intended for molecular biology applications. It was designed and validated for use in respiratory tract fluid specimen for detection of presence or absence of Mycobacteria tuberculosis complex, M. bovis, M. africanum, M. canetti, M. microti, and M. pinnipedii through amplification of the bacterial DNA markers IS6110 and MPB64.
The Co-Dx Logix Smart MTB test kit detects the bacteria within 40 cycles from respiratory tract fluid samples. Non-tuberculosis Mycobacteria are commonly present in the lungs and in the environment, and some may cause a tuberculosis-like disease. Mycobacteria can infect or spread to other parts of the body.
The marker IS6110 has been used for decades to detect MTB-complex members, although more recent studies showed that the IS6110 marker was not present in some isolates, and that MPB64 was found as an additional conserved marker to increase the sensitivity of tests designed for detection of the MTB-complex.
Test kit performance & specifications
Application
Qualitative PCR, screening
Limit of Detection
Sensitivity
Specificity
Sample type
Genotype detection
Multi-drug resistance
Type of detection
Time to detection
Thermal cycler compatibility
* Results based on 556 analytical samples extracted using QIAmp DNA Mini Kits, and run on the Magnetic Induction Cycler (MIC).
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Every test from Co-Dx is designed to be easy to use.
Regulatory clearance
In July 2018, the Co-Dx Logix Smart MTB test kit received CE mark approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic (IVD) for the diagnosis of tuberculosis in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.
This product is released for use as an in vitro diagnostic device, for export only and is not for sale in the United States.
