|
Tuberculosis (TB) remains a persistent global health challenge, particularly in low- and middle-income countries. Despite significant advances in treatment, the disease continues to claim millions of lives annually.
Central to the fight against TB is the global pharmaceutical industry, which plays a pivotal role not only in the development and distribution of anti-TB drugs but also in the innovation and deployment of diagnostic tools crucial for early detection and effective treatment.
One such groundbreaking innovation is the TBSend Card, developed by Wobble Base Bioresearch Private Ltd. This device addresses critical challenges in the TB diagnostics sample supply chain, providing a robust solution that could revolutionize TB management in resource-limited settings.
Global pharma industry & TB diagnostics
The global pharmaceutical industry has been at the forefront of TB diagnostics for decades, with significant investments in R&D leading to more accurate, cost-effective, and accessible diagnostic tools. Early and accurate diagnosis of TB is essential for effective treatment and prevention, yet traditional methods like sputum smear microscopy have limitations, particularly in sensitivity and specificity, especially for drug-resistant strains.
The advent of molecular diagnostics, such as the GeneXpert MTB/RIF test, has marked a significant advancement in TB diagnostics. These tests offer faster and more accurate results, crucial for timely and appropriate treatment. However, challenges remain, particularly in the accessibility and affordability of these advanced diagnostic tools in resource-poor settings, where the burden of TB is highest.
Logistical challenges in TB sample supply chain
The TB sample supply chain faces several significant logistical challenges, particularly in regions with inadequate infrastructure. Collecting, transporting, and analysing biological samples for TB testing often encounters barriers due to limited facilities and the vast distances between collection sites and diagnostic laboratories.
Maintaining sample integrity
Maintaining the integrity of TB samples during transportation is crucial. Any delays or improper handling can result in sample degradation, which compromises the accuracy of diagnostic results and leads to delayed treatment. Ensuring that samples remain viable and uncontaminated throughout the journey from collection to analysis is essential for reliable diagnostics.
Spillage and leakage risks
The transportation of biological samples poses a considerable health hazard, particularly concerning spillage and leakage. These issues not only risk contamination but also create significant health risks for those involved in handling and transporting the samples. Proper containment and secure packaging are critical to mitigating these risks and ensuring the safety of both the sample and personnel.
Infrastructure limitations
In rural and underserved areas, where healthcare infrastructure is often lacking, the challenges are exacerbated. The absence of reliable transport and storage facilities makes it difficult to manage TB samples effectively. Without proper infrastructure, the risks of sample degradation and mishandling increase, impacting the overall quality of TB diagnostics and patient care.
Overcoming logistical barriers
Addressing these logistical challenges is vital for enhancing TB management. Innovations in sample transportation and storage solutions are necessary to overcome the limitations of current systems. Developing more robust and practical solutions, such as the TBSend Card, can significantly improve the reliability of TB diagnostics by addressing the issues associated with sample transport and storage.
By overcoming these logistical barriers, it becomes possible to improve the accuracy and timeliness of TB diagnoses, particularly in regions where healthcare infrastructure is limited. Ensuring that patients receive prompt and effective care is crucial for controlling the spread of TB and ultimately achieving better health outcomes.
TBSend Card
The TBSend Card is a unique device that offers a solution to many of the challenges faced in the TB sample supply chain. It allows for the room temperature transportation, storage, and retrieval of nucleic acids (NA) over an extended period, ranging from 1 day to 6 years. This innovation is particularly valuable in regions where maintaining a cold chain is impractical.
One of the most significant features of the TBSend Card is its multi-level retrieval capability. The device supports sample retrieval at three levels:
Level 1: For use on CB NAAT platforms such as GeneXpert, which is widely used for rapid TB diagnosis and drug resistance testing.
Level 2: For endpoint and real-time PCR platforms, which are essential for various molecular diagnostic assays.
Level 3: For line probe assays (LPA), which are crucial for detecting drug-resistant TB strains.
Moreover, the TBSend Card includes an optional provision for whole genome amplification, a 10-minute one-pot protocol that offers ultra-high sensitivity, particularly valuable for LPA assays. This capability makes the TBSend Card a versatile tool that can support a wide range of diagnostic needs in TB management.
Development and funding of TBSend Card
The development of the TBSend Card began in 2015, supported by generous funding from the Bill & Melinda Gates Foundation and BIRAC, Government of India. This support has been instrumental in advancing the technology and ensuring its readiness for deployment in the field. The device is currently under the prestigious funding umbrella of the India Health Fund, part of the Tata Trust initiative, which further underscores its potential impact on TB diagnostics.
The TBSend Card is currently undergoing a rigorous biosafety study at a premier ICMR institute in the country. This study is a critical prerequisite before the device can be considered for widespread use. Following the completion of the biosafety study, the TBSend Card will be subjected to a country-wide multi-centric field trial, funded by the India Health Fund.
These trials will evaluate the device's performance across diverse real-world settings, ensuring that it meets the necessary standards for large-scale deployment. The outcomes of these trials are essential for validating the TBSend Card's effectiveness and ensuring its readiness for implementation on a broader scale.
Current TB sample transportation and storage solutions
TB continues to be a global health challenge, especially in regions with limited resources. Accurate and timely diagnosis is crucial for effective TB management, and a significant aspect of this process is the proper transportation and storage of biological samples. The integrity of samples from the point of collection to the laboratory is vital to ensure accurate diagnosis, particularly in detecting drug-resistant TB strains. This review explores the current solutions available in the industry for TB sample transportation and storage, highlighting their strengths, limitations, and potential areas for improvement.
Traditional sample transportation methods
Historically, TB sample transportation has relied heavily on conventional methods, such as cold chain systems, where samples are kept refrigerated or frozen during transit. This method is effective in preserving the viability of samples, particularly for sputum and other biological materials that are prone to degradation at room temperature. However, maintaining a cold chain can be challenging, especially in remote or resource-limited areas where access to electricity and reliable refrigeration is limited.
Strengths
Preserves sample integrity: Cold chain systems are effective in maintaining the viability of TB samples, which is crucial for accurate diagnostic results.
Widely adopted: Cold chain logistics are well-established and commonly used across various medical and research fields, making them a standard practice in TB sample transportation.
Limitations
Logistical challenges: Maintaining a cold chain requires reliable infrastructure, including continuous power supply and proper storage facilities, which may not be available in remote areas.
High costs: The need for refrigeration, specialized packaging, and temperature monitoring increases the overall cost of transportation, making it less feasible for widespread use in low-income regions.
Limited reach: Cold chain-dependent solutions are less accessible in regions with poor infrastructure, limiting their effectiveness in those areas most affected by TB.
DBS and dried sputum technologies
To address the challenges of cold chain logistics, alternative methods such as Dried Blood Spot (DBS) and dried sputum technologies have been developed. These methods involve collecting samples on specially treated paper, which allows them to be dried and stored at room temperature for extended periods.
Strengths
Room temperature storage: DBS and dried sputum samples can be stored and transported at room temperature, eliminating the need for refrigeration and reducing logistical challenges.
Cost-effective: These methods are generally less expensive than cold chain systems, as they do not require specialized equipment or continuous power supply.
Extended sample stability: Dried samples can remain stable for extended periods, making them suitable for long-distance transportation and storage.
Limitations
Limited applicability: While effective for some types of diagnostic tests, DBS and dried sputum samples may not be suitable for all TB diagnostic methods, particularly those requiring large volumes of high-quality DNA or RNA.
Potential for sample degradation: Although dried samples are generally stable, they may still be susceptible to environmental factors such as humidity and temperature fluctuations, which can affect the quality of the results.
Requires specific processing: The use of dried samples often requires additional steps during laboratory processing, which can increase the complexity of the diagnostic workflow.
Advanced molecular transport media
With the advancement of molecular diagnostics, new transport media have been developed to stabilize nucleic acids (DNA and RNA) during transportation. These media are designed to preserve the integrity of the genetic material at room temperature, allowing for more accurate molecular testing, even after extended periods.
Strengths
Nucleic acid preservation: Advanced molecular transport media effectively stabilize nucleic acids, making them suitable for high-sensitivity molecular tests such as PCR and GeneXpert.
Room temperature stability: These media eliminate the need for cold chain logistics, simplifying the transportation process and reducing costs.
Compatibility with multiple diagnostic platforms: Many of these transport media are compatible with a range of diagnostic platforms and increasing their versatility in TB diagnostics.
Limitations
Higher cost: Advanced molecular transport media are generally more expensive than traditional transport methods, which may limit their use in low-resource settings.
Limited availability: These solutions are often not as widely available as traditional methods, particularly in remote or underserved regions.
Processing requirements: The use of molecular transport media may require specific protocols and equipment in the laboratory, adding complexity to the diagnostic process.
TBSend Card - a revolutionary solution
Among the current innovations in TB sample transportation and storage, the TBSend Card stands out as a promising solution. The TBSend Card is a unique device that allows for the room temperature transportation, storage, and retrieval of nucleic acids over extended periods. The device is designed to address many of the limitations of traditional and alternative methods by offering a robust, versatile, and cost-effective solution.
Strengths
Extended stability: The TBSend Card ensures the stability of samples for up to 6 years at room temperature, making it ideal for long-term storage and transportation over long distances.
Multi-platform compatibility: The device supports sample retrieval at three levels, making it compatible with a wide range of diagnostic platforms, including C NAAT (such as GeneXpert), endpoint and real-time PCR, and line probe assays.
Cost-effective and easy to use: The TBSend Card eliminates the need for refrigeration and specialized transport, reducing costs and making it accessible even in low-resource settings.
Whole genome amplification capability: The device includes an optional provision for whole genome amplification, a 10-minute one-pot protocol that enhances sensitivity, particularly for line probe assays, making it a powerful tool for detecting drug-resistant TB strains.
Limitations
Ongoing validation: While the TBSend Card shows great promise, it is still undergoing validation through biosafety studies and multi-centric field trials. Widespread adoption will depend on the outcomes of these studies.
Initial adoption and scale-up: Like any new technology, the initial adoption and scale-up of the TBSend Card will require significant investment and collaboration with global and national health organizations and pharmaceutical companies.
Impact on TB diagnostics and public health
The TBSend Card has the potential to significantly impact TB diagnostics, particularly in resource-limited settings. By addressing the challenges of sample collection, storage, and transport, the device can improve the accuracy and timeliness of TB diagnosis, which is critical for effective disease management.
The ability to transport samples at room temperature without compromising their integrity is a major advantage, especially in remote areas where refrigeration and specialized transport facilities are unavailable. This feature can help extend diagnostic services to underserved populations, facilitating earlier detection and treatment of TB cases.
Furthermore, the TBSend Card's support for advanced molecular diagnostics, including whole genome amplification, makes it a powerful tool in the fight against drug-resistant TB. By enabling more sensitive and accurate testing, the device can help guide appropriate treatment regimens and prevent the spread of resistant strains.
The transportation and storage of TB samples remain critical challenges in the global effort to control and eliminate tuberculosis. Traditional cold chain methods, while effective, are often impractical in resource-limited settings, leading to the development of alternative solutions such as DBS, dried sputum technologies, and advanced molecular transport media. Each of these methods has its strengths and limitations, and the choice of solution often depends on the specific context and diagnostic needs.
The TBSend Card represents a significant advancement in this field, offering a practical, versatile, and cost-effective solution that could revolutionize TB sample transportation and storage. As the device undergoes further validation, it has the potential to fill critical gaps in the TB diagnostic supply chain, particularly in regions with limited infrastructure.
The future of TB diagnostics will likely involve a combination of these methods, tailored to the needs of specific populations and healthcare systems. Continued innovation and collaboration within the global pharmaceutical industry will be essential to ensuring that these solutions are accessible and effective in the fight against tuberculosis.
Role of pharma industry in scaling up innovations
For innovations like the TBSend Card to reach their full potential, the global pharmaceutical industry must play a key role in scaling up production and distribution. Pharmaceutical companies have the expertise and resources to ensure that such devices are manufactured at scale and distributed to regions where they are most needed.
Collaboration between Wobble Base Bioresearch and larger pharmaceutical companies can facilitate the integration of the TBSend Card into existing TB control programs. These partnerships can also help secure additional funding and support from global health organizations, ensuring that the device is available to all regions with a high burden of TB.
Moreover, the pharmaceutical industry can contribute to raising awareness about the importance of innovative TB diagnostics and the need for improved sample supply chains. Advocacy for the adoption of tools like the TBSend Card is essential for achieving the global goal of eliminating TB as a public health threat.
Conclusion
The ongoing battle against TB requires innovative solutions that address the complex challenges of diagnosis and treatment. The TBSend Card represents a significant advancement in TB diagnostics, offering a practical and effective solution to the challenges of the TB sample supply chain. With its unique capabilities for sample storage, transport, and retrieval, the TBSend Card has the potential to transform TB diagnostics, particularly in resource-limited settings. As the device moves through biosafety studies and field trials, its successful deployment could mark a turning point in the global effort to control and ultimately eliminate TB.
The global pharmaceutical industry has a critical role to play in supporting the scale-up and distribution of the TBSend Card, ensuring that this innovative solution reaches the populations that need it most. By fostering collaborations and advocating for the adoption of new technologies, the industry can help drive progress in the fight against TB, bringing us closer to a world free from this devastating disease.
(Dr Pratap N Mukhopadhyaya is director of Innovations
& Discovery, Krishna H Goyani serves as the People Lead &
Daisy Patel is senior research member of the MTB Group
at Wobble Base Bioresearch Private Ltd)
|