rt-LAMP Assay

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
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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,
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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.