Logix Smart MTB
01 Overview
02 Details
Logix Smart™ MTB Kit
The Logix Smart™ Mycobacteria Tuberculosis (MTB) Test is the first test built using our CoPrimer™ technology to receive regulatory clearance for use as an in vitrodiagnostic. It is designed to detect the presence or absence of deoxyribonucleic acid (DNA) of mycobacteria tuberculosis complex members.
Real-time polymerase chain reaction (PCR) amplifies the IS6110 and MPB64 regions of the pathogen genome. The amplified product is then detected by fluorescent dyes (FAM, CF560, and CF610).
Each Logix Smart MTB Kit contains a complete, ready-to-use master mix.
A human RNaseP gene marker serves as an Internal Positive Control (IPC) to monitor the quality of each reaction and is designed to also detect inadequate samples.
Nuclease Free Water is also provided for a negative control.
Each kit provides reagents sufficient for 100 reactions.
Intended Use
The Logix Smart MTB Kit is intended for molecular biology applications. This product is released for use as an in vitro diagnostic device, for export only and is not for sale in the United States.
The Logix Smart MTB kit was designed and validated for use in respiratory tract fluid specimen for detection of presence or absence of Mycobacteria tuberculosis complex M. tuberculosis, M. bovis, M. africanum, M. canetti, M. microti and M. pinnipedii through amplification of the bacterial DNA markers IS6110 and MPB64.
The Logix Smart MTB Test 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 they can 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.
* Results based on 556 analytical samples extracted using QIAmp DNA Mini Kits, and run on the Magnetic Induction Cycler (MIC).
