LOGIX SMART™ MTB KIT
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 vitro diagnostic. 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).
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Each Logix Smart MTB Kit contains a complete, ready-to-use master mix.
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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.
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Nuclease Free Water is also provided for a negative control.
Each kit provides reagents sufficient for 100 reactions.
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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.
Logix Smart™ MTB has been validated with QIAamp DNA Mini (QIAGEN) extraction kit and run using the CoDx Box™ Thermal Cycler
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Compatible with multiple sample types
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Contains a simple and streamlined work flow
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Includes internal control to verify sample quality
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Includes positive control
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Produces results that are easy to interpret
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Compatible with multiple platforms & sample extraction techniques
Analysis
<10 minutes
Extraction
<60 minutes
Assay Runtime
45-66 minutes
Product Performance Characteristics
Each Logix Smart™ MTB kit includes:
1x500µL (100rxns) Logix Smart™ MTB Master Mix
1x500µL (100rxns) Logix Smart™ MTB Positive Control
1x500µL (100rxns) Nuclease Free Water
Tuberculosis
According to the WHO – Global Tuberculosis Report of 2017, tuberculosis (TB) is the ninth leading cause of death worldwide, ranking even above HIV/AIDS. The estimated number of TB deaths in 2016 was 1.3 million among the HIV-negative population (although this number was an improvement from the 1.7 million deaths in 2000) with an additional 374,000 deaths from the TB-HIV co-infected population, compared to 826,000 deaths from HIV alone.
Due to the ability of tuberculosis to spread through the air as well as body fluids, early detection is critical to prevent transmission, accelerate treatment and continue to fight worldwide to combat the disease.