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Next Generation Rapid TB LAM Test for Mass Screening of TB in Urine and Other Body Fluids.

TB is an infectious airborne disease, whose main etiologic agent is MTb. Although TB is present in every country in the world, this disease mainly affects low-income and vulnerable populations. TB is among the 10 leading causes of death in the world, and the first as an infectious agent in HIV Positive patients. In 2019, TB was responsible for over 1 million deaths. WHO estimates that one-fourth of the world's population is infected with MTb.


Presently existing LAM urine test (Alere, Abbott, USA) has higher sensitivity & specificity, mainly in HIV co-infected TB patients, while its sensitivity and specificity are very less in active TB patients 17-40% average 26 percentage. We propose an improved version of a visual, qualitative, rapid, and affordable test (LAM-Based TB test) for mass screening of TB in urine. Tests are rapid, and results can be interpreted in 10 minutes. The proposed tests are suitable for doctors’ clinics and resource-constrained areas, and no refrigeration is required during storage and transportation. Lipoarabinomannan (LAM) is a potential marker of active tuberculosis (TB). The test is based on the detection of mycobacterial lipoarabinomannan (LAM) antigen in body fluids (blood and sputum etc) that can be used as a potential point of care test for tuberculosis (TB). LAM antigen is a lipopolysaccharide present in mycobacterial cell walls, which is released from metabolically active or degenerating bacterial cells and appears to be present only in people with active TB disease.


Urine-based testing would have advantages over sputum-based testing because urine is easy to collect and store, and lacks the infection control risks associated with sputum collection. This rapid Test is a membrane-based test for the rapid detection of cell wall antigen in urine. Our proposed TB test (detection of antigen in Urine) is rapid (20-25 minutes compared to 8 to 12 weeks for routine culture), low cost and affordable (compared to USD20 for Gene Xpert), do not require equipment, they are point of care easy to use tests and only small amount of sample is needed for the test. The tests can be performed in rural and resource settings where pathology labs or TB labs are not available.


We have completed clinical validation of Rapid Tests in urine samples of TB and HIV co-infected TB patients at one site (Fiocruz, Recife, Brazil) under the BRICS Project. As a result, we found higher accuracy than Alere LAM (Abbott) and FujiLAM (Japan) TB tests. Further, investigations and validation studies are going on in Fiocruz, Rio De Janeiro, Brazil to increase its accuracy and make it suitable for mass screening of TB in adult as well as pediatric TB populations in rural and resource-constrained areas of India, China, Brazil, and South Africa (High Burden Countries).

Highly Oxygenated Aerosol Controlled (HOAC) Combo Device For COVID-19 and Airborne Diseases (TB).

HOAC Device – A Breakthrough from AIIMS Raipur

Utility Patent Granted | Year of Invention: 2021


A Closed-System, Single-Patient, Non-Electronic Device for Safer TB & Airborne Disease Management

Developed by frontline healthcare professionals at AIIMS Raipur, the HOAC (Highly Oxygenated Aerosol Controlled) Device is a low-cost, disposable, and non-electronic medical innovation designed to transform lung therapy, infection control, and sputum diagnostics for TB and airborne disease patients.


This multifunctional closed-system device integrates five core respiratory therapies in one:


  1. Bio-aerosol controlled nebulization
  2. Incentive spirometry
  3. Active sputum sampling
  4. Oxygen mask therapy
  5. Non-Rebreather Mask (NRBM) oxygen delivery


It is purpose-built for both hospital and community settings, where infection control and patient recovery must go hand-in-hand.


Addressing Unmet Needs in TB & Airborne Disease Care

In TB care, productive cough and sputum collection are essential for diagnosis—but these increase infection risk when done in open areas like PHCs and CHCs. Similarly, nebulization and spirometry, while proven to reduce pulmonary complications and pleural effusion, are often avoided in TB and airborne patients due to the high risk of aerosol generation.


The HOAC device solves these challenges by enabling:


  1. Safe and contained nebulization for drug delivery without spreading aerosols
  2. Closed-system spirometry that supports lung rehabilitation even in oxygen-dependent TB patients
  3. Active sputum collection with built-in aerosol control, ideal for TB testing centers
  4. Enhanced safety during patient transfer using HOAC’s oxygen mask modes, preventing cross-infection during routine care


Key Features


  1. Non-Electronic & Disposable – Safe for use in low-resource, high-risk environments
  2. Closed Bio-Aerosol Control – Smart expiratory outlet uses basic physics: upward air expulsion and downward gravitational absorption using a dry sponge-based filter to reduce contaminated moisture
  3. Five-in-One Modular System – Nebulizer (HOAC-N), Spirometer (HOAC-IS), Sputum Sampling Mask (HOAC-SM), NRBM (AC-NRBM), and Face Mask (AC-FM)
  4. Clinically Designed at AIIMS Raipur – Based on real-time patient needs, especially during COVID-19 and TB peaks


Impact at a Glance


  1. Reduces bio-aerosol transmission and hospital-acquired infections
  2. Improves drug delivery efficiency and lung recovery
  3. Supports safer sputum sampling in diagnostic centers
  4. Consolidates fragmented therapies into one simple, disposable tool
  5. Enables standardized TB care even in rural and high-burden settings



From Frontline Service to Biomedical Innovation

This device was invented in 2021 by Arokiaraj U, Senior Nursing Officer at AIIMS Raipur (with doctors' support), who turned the hardship of treating patients in suffocating PPE kits and overcrowded ICU wards during the COVID-19 pandemic into an opportunity for meaningful, scalable healthcare innovation.


The HOAC device is now entering the fundraising and prototype development stage, followed by pivot studies and clinical validation, paving the way for large-scale deployment across India.

truGnom™

truGnom™ by Ruhvenile® Biomedical (www.ruhvenile.com) offers a transformative solution in the fight against tuberculosis (TB), addressing critical challenges in molecular diagnostics and research of any specimen.

Overcoming Limitations in TB Diagnostics

Modern molecular diagnostics, such as PCR, RT-PCR, NGS, and WGS, require high-quality, stable genetic material from diverse sample types. However, conventional transport and preservation media often face challenges, including microbial revival, cold chain dependency, and sample degradation, leading to unreliable results.​

How truGnom™ Addresses These Challenges

  1. Immediate Microbial Inactivation: truGnom™ neutralizes and lyses microbes upon collection, ensuring no further lysis is required for preserved samples. This immediate action prevents microbial revival and maintains sample integrity.
  2. Enhanced Nucleic Acid Yield: The medium achieves a 2.5–3X increase in nucleic acid isolation from any specimen, compatible with a diverse range of commercially available DNA and RNA extraction kits. ​
  3. Cold Chain Independence: truGnom™ eliminates the need for cold chain logistics for the first 72 hours post-collection, facilitating sample transport in resource-limited settings.​
  4. Long-Term Stability: It ensures long-term DNA/RNA stability for up to five years at -80°C, preserving the integrity of genetic materials for extended periods.​

Impact on TB Research and Public Health

By providing a reliable and efficient medium for specimen transportation and preservation, truGnom™ enhances the accuracy of molecular diagnostics and research reproducibility. Its adoption can significantly improve diagnostic accuracy and research outcomes, contributing to global efforts to end TB.​


Current users: Clinical sample Users: PGIMER, Chandigarh | AIIMS, Delhi | SKIMS, Srinagar | AIIMS, Bhopal | KEM Mumbai | MNC Chennai | IPGMER Kolkata | SGPGI Lucknow | SMS Jaipur | RIMS Manipur | Medical college, Thiruvananthapuram | NCL Pune & more Institutes…

Currently, all the above-mentioned 11 hospitals across India are using truGnom™ for immediate analysis and also genetic material preservation, followed by analysis of gallbladder tissue and associated specimens for deep and accurate analysis.

Dr LalPath lab also tested truGnom for their daily work and found it superior in terms of sample transportation, microbes’ inactivation, removing lyses step, accurate, reproducible, and reliable data. We are working with them to make a business deal.

We are ready to serve our indigenous patented product truGnom of any quantity if you want to adapt new technologies!

For more information on truGnom™ and its applications in TB diagnostics and research, please visit www.ruhvenile.com | info@ruhvenile.com | +91 8587033367 | +91 11 3501 7209

TBSend Card: Sputum Transport, Storage, and Electricity-Free DNA Release Device

The TBSend Card is a cylindrical device designed for the safe collection, preservation, and transportation of sputum samples for nucleic acid testing. It houses a chemically coated stack of filter cards and can be opened from both ends as well as from the side.To use the device, sputum is added to a buffer-filled vial, mixed well, and then spotted onto the filter card through one end of the device. Once processed, the sample can be safely transported at room temperature. The preserved nucleic acids remain stable on the cards, which should be stored at room temperature, for over six years without degradation.For nucleic acid extraction, an elution buffer is added through the other end of the device, and the device is placed on a rack for a minute. The nucleic acid-containing buffer (~1.4 mL) is then collected through the side opening. This eluted sample can be directly loaded onto a GeneXpert cartridge or any other CB-NAAT assay system.For other nucleic acid amplification tests (NAATs), the 1.4 mL eluate is processed by adding a binding buffer and magnetic beads, followed by mixing and washing on a magnetic rack. The final nucleic acid extract (3050 c2b5L) can then be used in various diagnostic platforms, including qPCR, endpoint PCR, isothermal assays, and line probe assays.The entire process is electricity-free, requires no centrifugation, and is suitable for remote and resource-limited settings. Importantly, the device ensures biosafety during sample handling, transport, and storage.

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