Co-Dx™ PCR Mycobacterium Tuberculosis (MTB) Test Kit*
The Power to Know™ with the Co-Dx PCR platform and the Co-Dx PCR MTB Test
MTB testing anywhere
The Co-Dx PCR Pro™* and Co-Dx PCR MTB test advance our mission to support early detection, reduce transmission, and strengthen testing programs in regions heavily burdened by TB, by expanding access to affordable, high-quality TB testing in low- and middle-income countries.
On-site MTB PCR test results in less than 40 minutes
The Co-Dx PCR MTB Test process is included in the Instructions for Use (IFU) and used alongside the Co-Dx PCR Pro mobile app to help guide the operator. This enables the sample collection, sample lysis, and the testing process–all at the point-of-care. Once the test is complete, results are available on the test operator’s mobile device.
Collect a sample (swab method)
Collect a sample (sputum method)
Mix sample in solution
Process the sample
Fill PCR Pro Test Cup
Place test cup in Co-Dx PCR Pro instrument
Test kit specifications
Application
The Co-Dx PCR MTB Test kit has been designed for use with sputum and tongue swab samples on the Co-Dx PCR Pro™, for detection of presence or absence of Mycobacteria tuberculosis.
Sample type
Tongue Swab / Sputum
Limit of detection
TBD
Time to results
<40 minutes
Target Detected
Mycobacteria Tuberculosis
Kit sizes
10
Test kit components
The Co-Dx PCR MTB Test Kit includes the following components:
- Co-Dx PCR MTB Test cup (10)
- Tongue swab (10)
- Single sample elution buffer ampule (10)
- Sample lysis tube with filtered lid (10)
The following materials are required, but not provided with this kit:
- Co-Dx PCR Pro instrument (sold separately)
- Sample lysis device (contact your Co-Dx representative for compatible devices)
- iOS or Android compatible mobile device
- Co-Dx PCR Pro Mobile App (iOS or Android)
*The Co-Dx PCR Pro instrument and associated Co-Dx PCR tests are not yet approved or cleared by the U.S. Food and Drug Administration (FDA) or other regulatory bodies and are not released for use in diagnostic procedures. Not available for sale.
Other Co-Dx PCR platform products
Other Co-Dx PCR platform products
Co-Dx PCR HPV Test Kit*
Currently in development
Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit*
Currently in development
Co-Dx PCR COVID-19 Test Kit*
Currently in development
