Rapid Results
Actionable results in just a few hours
Internal Control Included
Monitors validity of assay set up and PCR inhibition
Compatible Platform
Designed for use on existing laboratory equipment
Efficient Workflow
Streamlined protocol for routine molecular laboratories
Improved diagnostic confidence
High Sensitivity & Specificity of results
Early Detection
Confirmation of TB disease ensuring faster treatment
EMPE Diagnostics has developed mfloDx™ technology (patents granted), a diagnostic platform combining the padlock probe-dependent rolling circle amplification (RCA) and ultrasensitive lateral flow biosensors. This integrated approach allows for the rapid, accurate, and cost-effective detection of Mycobacterium tuberculosis complex (MTBC) and its resistance to key antibiotics rifampicin (RIF) and isoniazid (INH) directly from sputum samples within three hours. The detection signal is processed and visualized using a lateral flow cassette, like a home pregnancy or COVID-19 test, in which the “wild type” (WT) and “mutant” (MUT) windows on the cassette indicate the presence of the bacterium and its specific drug resistance profile. This technology enables clinicians to get a qualitative “Yes” or “No” result for both TB presence and drug resistance, facilitating the prompt initiation of correct treatment, especially in resource-limited settings. The mfloDx™ MDR-TB kit (CDSCO approved) is currently available for purchase.
Pack Size
AMP Kit Contents
| Name of the Product | Quantity supplied with the kit |
|---|---|
| PCR mix | 1 x 360.0 µl |
| LIG mix | 1 x 450.0 µl |
| RCA mix | 1 x 480.0 µl |
| DIG mix | 1 x 112.5 µl |
| Enzyme E-1 | 1 x 9.0 µl |
| Enzyme E-2 | 1 x 25.0 µl |
| Enzyme E-3 | 1 x 20.0 µl |
| Enzyme E-4 | 1 x 12.5 µl |
| MAG | 1 x 75.0 µl |
| BWB | 2 x 1.25 ml |
Storage and Handling (AMP)
- The mfloDx™ MDR-TB AMP Kit should be stored at -25 °C to -16 °C.
- The number of freeze-thaw cycles with the 25-test kit is 4. Beyond 4 times, the kit cannot be used and the results obtained beyond 4th cycle may not be considered for interpretation.
VIS Kit Contents
| Name of the Product | Quantity Supplied with the Kit |
|---|---|
| VIS-1 | 2 x 937.5 µl |
| VIS-2 | 1 x 1.0 ml |
| Cassettes | 1 x 25 No. |
Storage and Handling (VIS)
- The mfloDx™ MDR-TB VIS Kit should be stored at +2 °C to +8 °C.
- The number of freeze-thaw cycles with the 25-test kit is 4. Beyond 4 times, the kit cannot be used and the results obtained beyond 4th cycle may not be considered for interpretation.
EMPE TBDx is a high-performance real-time PCR assay designed for the rapid and accurate detection of Mycobacterium tuberculosis complex (MTBC) from pulmonary samples. Delivering reliable molecular results within hours, the assay supports early diagnosis and timely treatment decisions. Our test is ideal for hospital molecular laboratories, reference centres, public health TB control programs and high-burden and decentralized testing settings. EMPE TBDx enables early confirmation of TB disease, improved diagnostic confidence and faster clinical decision making. The EMPE TBDx kit is currently available for purchase as a Research Use Only (RUO) product.
EMPE TBDx (RUO) Launch Celebration Offer
To celebrate the launch, enjoy our exclusive promotion:
Buy 2 kits for the price of 1.Offer valid until 30th April 2026!
Order Now!Pack size
Kit Contents
| Component | Volume (µl) |
|---|---|
| Master mix | 1 x 737.5 |
| Probe mix | 1 x 12.5 |
| ROX (Optional)* | 1 x 7.5 |
| Product Insert | 1 |
*The mastermix already contains ROX dye. Use additional ROX for instruments like Applied Biosystems 7000, 7300, 7700, 7900, 7900HT, StepOne, StepOnePlus.
Storage conditions
- The EMPE TBDx Kit should be stored at -15 °C to -25 °C.
