DNA/RNA To Ct Values in under 30 minutes.

Real-Time Loop Mediated Isothermal
Amplification'RT-LAMP'

Molecular chemistry that allows for the rapid detection of DNA/RNA nucleic acids in under 30 minutes using dual-labelled probes.

RT-LAMP is poised to replace RT-PCR chemistry in the qualitative detection of DNA/RNA sequences due to its ability to rapidly amplify and detect gene targets without compromising on the analytical sensitivity and specificity. The chemistry is intended to be deployed on RT-PCR instruments and allows for intrepretation of results much like real-time PCR.

The chemistry can be easily adapted to point-of-care instruments that automate nucleic acid extraction, assay-setup, and detection into a closed system.

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 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.

Phase II clinical evaluation is now ongoing to compare the results of CitaXpress with LJ/MGIT cultures.