SCTIMST rt-LAMP Test for Early Tuberculosis Detection
Why in the news
A Kerala institute developed a molecular TB test said to match GeneXpert and Truenat on accuracy while costing less.
Key facts
- Sensitivity: spots DNA at 10 copies per microlitre.
- Single temperature: RT-PCR needs three settings.
- Real time: dye Syto 16 lets the reaction be tracked every minute.
- Speed: six primers, positive results in 10-20 minutes.
- Specificity: all six primers must bind first; no probes, which lowers cost.
Evaluation
| Item | Detail |
|---|---|
| Samples | 350 presumptive pulmonary TB sputum samples |
| Phases | Oct 2019-Mar 2020 and Jan 2023-Mar 2024 |
| Compared with | Microbiological reference standard, GeneXpert, smear test |
| Result vs reference | 89.36% sensitivity, 94.06% specificity |
Advantages
- Works on existing RT-PCR machines reprogrammed to one temperature.
- High throughput: 96 or 384 samples per run.
- Open-platform design for easy integration.
Approval status
- Licensed to industry and approved by CDSCO.
- ICMR validation in progress; the WHO Health Technology Access Pool is waiting on it.
India’s TB testing gap
- In 2023 about 79% of presumptive cases were diagnosed by sputum smear microscopy and 21% by molecular tests.
- Molecular facilities rose from 5,090 (2022) to 6,496 (2023), yet the National Strategic Plan 2017-2025 goal remains hard.
Exam angle
- Institute: SCTIMST, Thiruvananthapuram.
- Dye: Syto 16.
- Related terms: LAMP, GeneXpert, Truenat.