Technology

Our technology will offer rapid diagnostic to provide timely and proper treatment.

Overview

The World Health Organization (WHO) recommends initial diagnostic tests for adults and children presenting TB symptoms to achieve its End TB Strategy to end the global epidemic by 2035. Too many undetected patients have a higher risk of transmitting the disease and may suffer distress and economic hardship.  

Early detection of tuberculosis disease is critical to initiate the proper and timely treatment. Rapid and accurate diagnosis with a point of care (POC) test does not require extensive laboratory infrastructure and can reach low resource communities. 

Point-of-care testing (POCT) offers multiple advantages to resource-limited communities including: 

  • Fast and simple specimen handling. 
  • No additives. 
  • No transportation. 
  • Diagnosis in less than an hour.   

REFtb Technology

The Reporter Enzyme Fluorescence technology (REFtb) uses fluorescence to track, detect, and diagnose infectious agents with greater sensitivity than existing technologies. It will meet the WHO target product profile for an inexpensive, simple, sputum-based point-of-care (POC) DST, and it requires minimal training. 

REFtb-DST relies on the enzymatic activity of the TB beta-lactamase (BlaC) that depends on ATP levels for secretion and will detect drug resistance regardless of the nature of the mutation.

In addition, REFtb detects the viability of intact Mtb due to the requirement of ATP for BlaC secretion and does not require bacterial replication to obtain a positive signal, making REF useful for true drug-susceptibility testing (DST).

What is BlaC?

BlaC is a β-lactamase enzyme secreted when the bacteria are grown under laboratory conditions. It is used as a biomarker with BlaC-specific fluorogenic substrates for rapid and accurate detection of very low numbers of M.tuberculosis in clinical diagnosis.

How does it work?

The REFtb system consists of:

  1. Sputum collector to obtain the patient sputum sample
  2. Reagent system 
  3. Reader 

The REFtb reagent mix contains buffer and reagents to counter known sputum inhibitors of the assay.

Our technology will be portable and battery-operated to be used in low-resource settings without proper laboratory infrastructure.

In addition, REFtb detects the viability of intact Mtb due to the requirement of ATP for BlaC secretion and does not require bacterial replication to obtain a positive signal, making REF useful for true drug-susceptibility testing (DST).