The World Health Organisation (WHO) has endorsed Goa-based Molbio Diagnostic’s rapid molecular TrueNat testing for initial diagnosis of tuberculosis (TB) and the detection of rifampicin resistance.
The Foundation for Innovative New Diagnostics (FIND), Molbio Diagnostics and Indian Council of Medical Research (ICMR), announced that the WHO has endorsed three of their rapid molecular Truenat assays for initial diagnosis of tuberculosis (TB) and subsequent detection of rifampicin resistance in adults and children with signs and symptoms of pulmonary TB.
Both, TrueNat MTB and TrueNat MTB Plus detect mycobacterium tuberculosis bacteria for TB diagnosis, while TrueNat MTB-RIF Dx identifies resistance to rifampicin, the most commonly used first-line treatment.
All three tests are run on the portable, battery-operated TrueNat device and provide results in less than an hour.
Drug-resistant TB also poses a particular threat, with growing resistance to rifampicin and other drugs that treat TB. TB remains the leading cause of death among infectious diseases worldwide and accounts for around 10 million cases and 1.5 million deaths in 2018. In the same year, around half a million new cases of rifampicin-resistant TB were reported.
The TrueNat test uses real-time micro polymerase chain reaction (PCR) technology. This Verna-based company has also prepared and received ICMR approval for their TrueNat Beta CoV test used for testing of the presence of the novel Corona virus, Covid-19.
TrueNat is developed by Bigtec Labs, the R&D subsidiary of Molbio Diagnostics.
ICMR conducted multicentre validation of TrueNat MTB and TrueNat MTB-RIF Dx assays followed by the feasibility study under the national programme and found them to be on par with the internationally recognized molecular assays in terms of sensitivity and specificity, and detection of rifampicin resistance.
TrueNat assays have now been incorporated into the India National TB Elimination Programme (NTEP) after recommendations from the ICMR.
The CEO of Molbio Diagnostics, Sriram Natarajan expressed his delight at this development. “We are thrilled to have WHO endorsement of TrueNat as a point-of-care platform that would help universal access to TB molecular diagnostics in countries with endemic TB. India has already leveraged the power of TrueNat to decentralise TB detection, and we look forward to working with other national TB programmes to help achieve their TB elimination goals.”
