Detect mTB DNA in under 20 minutes.

Delivering rapid molecular results is critical to scaling up of public-health infrastructure for large scale screening.

India is considered to be a high-incidence territory for Tuberculosis related infections, efforts towards eradication involve undertaking a population level screening program to identify individuals infected with TB.

Availability of rapid and high-throughput molecular in-vitro diagnostics has the potential to replace or supplement smear microscopy as the first-line screening tool for detection of mycobacterium tuberculosis.

CitaXpress Process Flow and Data Output

RT-LAMP uses 6 oligonucleotide
primers that can rapidly amplify DNA/RNA sequences in less than 30 minutes.

Loop-mediated isothermal amplification (LAMP) uses 6 primers specific to distinct regions of target DNA/RNA for a highly specific amplification reaction.

A strand-displacing DNA polymerase initiates synthesis and loop primers facilitate in subsequent rounds of amplification. DNA products are formed from numerous repeats of the short target sequences, associated with the loop primers.

Real-time fluorescence detection using probes is directly compatible with LAMP reactions. Instrumentation for LAMP typically requires consistent heating to the desired reaction temperature and and real-time fluorescence for quantitative measurements.

Clinical Evaluation Update

citaXpress mTBC is being evaluated as a replacement to AFB smear microscopy in the diagnosis of pulmonary tuberculosis.

New Delhi, 25 April 2024

A preliminary clinical evaluation study undertaken at the National Institute of Tuberculosis and Respiratory Diseases 'NITRD' in New Delhi, India compared the performance of AFB Smear Microscopy against citaXpress mTBC in detecting mTB in sputum specimens. Phase 1 results demonstrated a PPA of 100% and a NPA of 86% between AFB smear and citaXpress mTBC. The results of citaXpress mTBC were further compared to an open RT-PCR IVD assay for detection of mTBC and the PPA was found to be 100% and the NPA was found to be 97% in favour of citaXpress mTBC.