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- New rt-LAMP Assay for TB Detection: Researchers at SCTIMST have developed a novel, cost-effective rt-LAMP assay for early TB diagnosis.
- High Sensitivity and Specificity: Similar to GeneXpert and Truenat, it’s a molecular test detecting TB DNA at low concentrations (10 copies/microlitre).
- Overcomes Dye Inhibition: Uses Syto 16 fluorescent dye, resolving false negatives in earlier LAMP tests.
- Rapid Results: Provides results in 10-20 minutes, significantly faster than RT-PCR.
- Simplified Process: Works at a single temperature, unlike RT-PCR’s three temperature cycles.
- Enhanced Amplification: Uses six primers for faster, more specific DNA amplification.
- Cost-Effective: No probe is used, and the dye and primers are inexpensive.
- Open Platform System: Existing RT-PCR machines can be repurposed for TB diagnosis by programming them to run at one temperature setting.
- High-Throughput Testing: Allows processing of 96 or 384 tests in a single run.
- Validation and Approval: Licensed to industry, approved by CDSCO, being validated by ICMR, and evaluated by WHO’s HTAP (pending ICMR validation).
- Addresses Diagnostic Gap: Aims to replace reliance on sputum smear microscopy (used in 79% of presumptive cases in India).
- Supports TB Elimination: Enables faster case detection and improved public health outcomes, supporting India’s National TB Elimination Programme (NTEP).
- Superior Performance: Showed 89.36% sensitivity and 94.06% specificity compared with MRS.
