Atlas of TB Innovations: Mapping the Future

Truelyse

Truelyse™, a rapid sample preparation system by Molbio Diagnostics Limited, addresses this most persistent barrier in TB diagnosis. Designed to make TB testing faster, simpler, and more patient-friendly, especially for the key population, Truelyse uses oral swab-based testing to detect TB.

While sputum remains the standard specimen for pulmonary TB, reliance on sputum-based diagnosis often excludes key populations—children, older adults, people living with HIV, and immunocompromised patients—who are unable to produce an adequate sputum sample. As a result, nearly one in four people with TB—and a significantly higher proportion among children and PLHIV—risk being delayed or missed within the care cascade.

How it works:

Unlike conventional workflows that depend on complex extraction reagents and time-intensive processing, Truelyse uses high-frequency mechanical agitation to break open bacterial cells in about 90 seconds. This process efficiently releases nucleic acids that can be directly amplified on Truenat MTB Ultima, enabling a seamless and accelerated path from sample collection to TB detection, cutting down the sample-to-result time in half.

Truelyse at a Glance:

Oral swab-based TB testing with Truelyse and Truenat MTB Ultima offers significant advantages:

1. Enables non-invasive oral swab sampling for people unable to produce sputum
2. Rapid processing (about 90 seconds), helping shorten time-to-result
3. Designed for decentralised settings, including rural and resource-limited locations
4. Patient-friendly workflow, suitable for community-based screening

By expanding sample options and simplifying molecular workflows, Truelyse™ strengthens TB diagnosis in settings where traditional sputum-based testing often becomes a bottleneck. It is particularly valuable in pediatric TB and HIV–TB co-infection contexts and supports community screening and field-based diagnosis, helping bring molecular TB testing closer to where patients first seek care.

Conclusion:

Truelyse™ enables a more inclusive, decentralized, and practical approach to TB diagnosis at the point of care.

Autonomous Mobile AI Integrated UV-C Disinfection Robots

Autonomous Mobile AI Integrated UV‑C Disinfection Robot refers to mobile robots developed by Haystack Robotics, aimed at performing disinfection tasks in indoor environments using UV‑C light, with AI and robotics for automation. It comes under the category of filtration & disinfection innovations in India. These robots are meant to reduce infectious pathogens (viruses, bacteria, fungi, and spores) on surfaces and in air, without relying on chemical disinfectants. They are designed for hospitals, public spaces, offices, etc.

Key Features & Capabilities

Here are the main technical/functional features of the Haystack UVC robots:

Use Cases & Advantages:

1. Hospitals (patient rooms, operating theaters, ICUs, etc.) are places where consistent, high-level disinfection is critical. Public spaces, offices, schools, hotels, etc.
2. Places with high footfall and high-touch surfaces where manual cleaning may miss spots or be inconsistent.
3. Situations where chemical disinfectants are undesirable (due to residue, smell, safety, etc.).
4. Reduced human exposure to pathogens and to cleaning chemicals.
5. Labor cost/time savings: frees human staff from tedious, dangerous, or repetitive tasks.
6. Better coverage: due to mobility and AI-based attention to high-touch areas.

qXR

qXR is an AI-powered chest X-ray interpretation tool developed by Qure.ai. Trained on over 10 million scans, it provides pre-read assistance in less than a minute, detecting abnormalities across the lungs, heart, pleura, mediastinum, bones, and diaphragm. qXR has been deployed in over 100 countries across 4700+ sites, processing more than 35 million scans. It has achieved a 40% reduction in turnaround time for reporting by classifying normal X-rays with a 99% negative predictive value. The tool supports multilingual interfaces and can be deployed on the cloud or on-premise, making it adaptable to various healthcare settings globally.

1. Deployment Options
2. Flexible architecture: Available as cloud-based SaaS or on-premise installation, depending on hospital data policies and compliance requirements.
3. Interoperable: Fully compatible with DICOM standards, PACS, RIS, and HL7/FHIR integrations.
4. Scalable: Handles high-volume deployments across multi-site health systems and national screening programs.
5. Edge/Offline Use: Designed for regions with low connectivity—supports local processing and later sync.
6. AI–Human Collaboration:
7. qXR works as a radiologist’s AI assistant, automatically flagging and prioritizing abnormalities while providing visual heatmaps for transparency, allowing clinicians to quickly clear normal studies and focus attention on critical or suspicious cases.
8. Workflow Integration
9. Native integration: Embeds directly into existing radiology systems without altering established workflows.
10. PACS/RIS plugin: Automatically analyzes incoming X-rays and attaches AI results (PDF/DICOM SR or overlay) to the same study.
11. Automated routing: Enables case prioritization and structured reporting for both teleradiology and in-hospital radiology departments.
12. Multi-modality support: While optimized for chest X-rays, modules can be integrated alongside CT-based AI tools for holistic diagnostic environments.
13. Accuracy and Performance
14. Detection coverage: >30 chest pathologies, including tuberculosis, pneumonia, nodules, pleural effusion, cardiomegaly, pneumothorax, and fractures.
15. Processing speed: Average inference time <1 minute per CXR, even in high-throughput environments.
16. Clinical accuracy:
17. Sensitivity (for key findings like nodules, TB): ~84–90%
18. Specificity: ~60–70% for TB (depending on module and population)
19. AUC (aggregate): 0.9 in validation studies
20. Operational performance: Up to 40% reduction in reporting turnaround time (TAT) and significant backlog reduction in multi-site deployments.
21. Regulatory and Global Readiness
22. Certifications:
23. CE-MDR Class IIb certified (Europe)
24. FDA 510(k) cleared for select modules (e.g., lung nodules, pneumothorax triage)
25. WHO-endorsed in TB triage workflows
26. Compliant with HIPAA, GDPR, and other data privacy frameworks.
27. Deployed in over 100 countries and 4700+ sites, including hospitals, government TB programs, and teleradiology providers.
28. Validated on multi-ethnic datasets, ensuring generalizability across geographies.

Quantiplus® MTB Fast Detection Kit

Quantiplus® MTB Fast Detection Kit

Developed by Huwel Lifesciences, the Quantiplus® MTB Fast Detection Kit is a rapid, extraction-free, open RT-PCR solution designed to overcome key diagnostic barriers. It delivers confirmatory TB results in under 40 minutes using standard PCR machines, eliminating the need for proprietary equipment and complex workflows. This makes Quantiplus® both affordable and scalable for decentralized TB testing.

Despite advances in molecular diagnostics, tuberculosis detection in India continues to face major barriers. High costs, proprietary closed systems, infrastructure demands, and limited geographic reach prevent widespread adoption.

Limitations of Existing Methods

1. Low sensitivity of smear microscopy: Misses nearly one-third of TB cases, leading to false negatives and delayed treatment.
2. Restricted access to molecular tests: High equipment costs, closed systems, and complex extraction workflows limit scale-up.
3. Underdiagnosis of pediatric and extrapulmonary TB: Conventional tests are poorly suited for non-sputum and paucibacillary samples.
4. Slow turnaround and contamination risks: Extraction-based workflows take over two hours and involve multiple handling steps.
5. Limited rural and last-mile reach: Infrastructure gaps and a shortage of trained personnel hinder deployment.

Key Features of the Quantiplus® MTB Fast Detection Kit:

1. Extraction-Free QLB Method: Achieves complete mycobacterial lysis and crude nucleic acid release in a single step.
2. Simplified Workflow: Direct addition of lysate into pre-aliquoted RT-PCR reagents eliminates the need for centrifugation, incubation, or multiple transfers—resulting in a contamination-free process.
3. Multiplex Design: Simultaneously amplifies three MTBC targets, ensuring specificity across seven complex species.
4. Limit of Detection: 100 IU/mL, validated on the NIBSC 1st WHO MTB DNA standard (Cat No. 20/152) and Qnostics panel (MTBEP01-B).
5. Wide Sample Compatibility: Supports sputum, tongue swabs, BAL, pus, CSF, pleural/ascitic/synovial fluids, urine, and culture specimens.
6. Universal Compatibility: Works with standard thermocyclers and is scalable to high-throughput labs or portable point-of-care PCR units.
7. Minimal Infrastructure Requirements: Only a bench-top heat block and open-system RT-PCR machine are needed.
8. Regulatory Approvals: Prequalified by ICMR, CDSCO-approved, and validated through third-party testing at Infexn Labs.
9. Proprietary Collection and Lysis Method: Patent filing for a swab-based method enabling direct TB capture and amplification.
10. User-Friendly Format: Comes in an 8-tube strip format with pre-aliquoted, ready-to-use reagents.

Proven Performance and Real-World Validation

Laboratory and ICMR-led evaluations have demonstrated strong diagnostic performance. The field study demonstrated 85.03% sensitivity, 91.64% specificity, and 90.08% overall diagnostic accuracy. Field feasibility studies in decentralized settings confirmed reliable performance, operational simplicity, and suitability for high-volume testing. A health technology assessment is underway to further support its potential for scale-up under the National Tuberculosis Elimination Programme (NTEP).

Enabling Access, Accelerating Impact

Priced at approximately ₹150 per test, Quantiplus® brings laboratory-grade molecular accuracy to the point of care. By enabling rapid, reliable, and affordable TB diagnosis in underserved settings, it empowers healthcare systems to detect cases earlier, initiate treatment faster, and reduce transmission—driving meaningful progress toward TB elimination.

Implementation Progress

Significant advancements include completed Quantiplus Nikshay interoperability (ICMR-approved for imminent rollout). State-level evaluations: Tamil Nadu (three district sites) and Uttar Pradesh (integration with ~85 COVID-era RT-PCR instruments). The Swaminathan Foundation supports uptake in Tamil Nadu and Odisha.

Key Initiatives

1. ACT Grants & PATH Feasibility Study: Deploys Quantiplus® kits and 100 UniAmp NAT Devices across 8 pilot sites; targets 4,000 tests to assess decentralized scalability.
2. Swasthya Nagaram Project (with The Union): Large-scale urban TB screening in Telangana; tests 30,000 community samples using Quantiplus® RT-PCR and portable X-ray.