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Co-Dx™ Logix Smart® Mycobacteria Tuberculosis (MTB) test kit

Boost speed and accuracy with real-time PCR testing

The Co-Dx Logix Smart MTB test kit is the first test built using our Co-Primers™ technology to receive a CE marking for use as an in vitro diagnostic. It is designed to detect the presence or absence of DNA of Mycobacteria Tuberculosis complex members.
Man in a medical setting testing a boy for Mycobacteria Tuberculosis with a saliva swab

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

The Co-Dx Logix Smart MTB test kit includes the following 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


Qualitative PCR, screening

Limit of Detection
2 copies/μL
8 copies/μL
100% (97.5 – 100%)*
99.3% (96.2 – 100%)*
98% (94.3 – 99.6)*
100% (97.6 – 100%)*
Sample type
Sputum and extra-pulmonary samples
Genotype detection
Multi-drug resistance
Type of detection
Presence/absence of the IS6110 and MPB64 gene from tuberculosis complex members, including the following Mycobacterium species M. tuberculosis, M. bovis, M. africanum, M. canetti, M. microti, M. pinnipedii
Time to detection
45-66 minutes, depending on the machine used to run PCR
Thermal cycler compatibility
Most machines including: MIC

* Results based on 556 analytical samples extracted using QIAmp DNA Mini Kits, and run on the Magnetic Induction Cycler (MIC).

Request a quote​

Contact us for more information about the Co-Dx Logix Smart MTB test kit.

Get started

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.