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).
- 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.
Logix Smart™ MTB Kit product brochures click links to download PDFs :
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).
Instructions for Use can be found under the Resources tab.
Kit Specifications
Regulatory Clearance
In July 2018, the Logix Smart MTB Test kit received CE mark approval, the principle regulatory clearance allowing the test to be sold as anin 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.
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.
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Logix Smart MTB Kit