Researchers from IIT Kharagpur have developed a unique Rs. 2-paper strip that can perform various pathological tests by using a tiny drop of blood taken from a finger-prick
By: Neelam Jhangiani
It is estimated that diabetes, both type 1 and type 2, currently affects more than 195 million people worldwide. This figure is expected to rise to more than 330 million by 2030. Diabetes is a growing challenge in our country with an estimated 8.7% diabetic population in the age group of 20 and 70 years. To avoid the complications of diabetes, it is important to keep blood glucose levels under check and minimise the risk of hyperglycaemia, thereby preventing the complications of diabetes. From early detection and diagnosis of disease to individualised treatment plans based on a person’s unique genetic makeup, clinical lab testing is key to improving healthcare quality and containing long-term health costs.
Self-monitoring of blood glucose (SMBG) is an essential part of managing diabetes and can help both patients and their healthcare professionals better adjust to therapy and assess the responses to therapy. It allows to see the impact of the measures being taken for better control. Good control of blood glucose – detected by lab tests – can delay or prevent diabetes complications such as heart disease, stroke, blindness, kidney disease, amputation, and even death.
Researchers from IIT Kharagpur, led by Professor Suman Chakraborty of the Mechanical Engineering Department and his team have developed unique low-cost paper strips that can perform various pathological tests by using a tiny drop of blood taken from a finger-prick. It is integrated with a smartphone device for analytics and readout. The background research work has been supported by the Royal Academy of Engineering (UK), Department of Scientific and Industrial Research, Government of India (GoI), Department of Electronics and IT, GoI, Department of Science and Technology, GoI, Indian Council of Medical Research and the Ministry of Human Resources Development, GoI through the IMPRINT India initiative, in various stages.
Giving a closer look at the device, Prof. Suman Chakraborty speaks about the blood testing device and future projects in pipeline for the healthcare industry.
With other devices already in the market, how is your device different & more viable?
We have developed unique low-cost paper strips, which can estimate various blood parameters (Glucose, Hemoglobin) by using a single drop of finger-prick blood. Integrated with a smartphone device for analytics and readout, this device has been successfully tested on field, both in clinical environment and beyond where structured clinics do not exist. The device essentially comprises a paper strip, a smartphone, and a simple plastic box fitted with LED light for holding the smartphone and imaging with the same simultaneously.
The device is designed to harness the flow of blood from a source pad to a reaction pad via simply-printed tiny channels on paper by capillary action, and eventually manifesting the reaction in the form of a color change that corresponds to the quantification of a blood parameter such as glucose (sugar) and hemoglobin. While the device is designed to be generically applicable for detection of any diseases that produces such color signals in a body fluid (such as blood, urine, saliva), the device has been extensively validated for the specific determinations of blood glucose and hemoglobin, by comparing with the results from expensive benchmark laboratory setups.
Arguably, there are other devices available in the market for doing similar tasks. This device, however, is unique in many ways; first and foremost, the test-strip is made by simple printing of channels on a small piece of paper. This, along with a few drops of other chemicals, is the only consumable in the test, which makes it ultra-low cost (around 2 INR per strip). Moreover, in sharp contrast to other commonly available glucose measuring portable devices, this device first separates the watery part of blood, also known as plasma, from whole blood by integrating a unique miniature membrane filter with the same paper strip. This effectively separates plasma from whole blood and directly reports plasma glucose. On the other hand, most other available portable devices measure glucose from whole blood and use a statistical correlation to estimate plasma glucose based on that. Universal nature of such correlation, however, remains questionable. Notably, medical treatment guidelines are based on plasma glucose and not on whole blood glucose.
The team has also tested the device for blood hemoglobin level estimation, which is utterly significant to assess public health status in general and maternal and child health in particular. The device can reproduce established pathological results from a simple chemical protocol that produces a discernible and quantifiable color signal. Compared to other reported portable devices for hemoglobin estimation, this device is of significantly low-cost, implementable without any trained personnel at resource-limited settings and provides quantitative results comparable to the pathological results.
What makes it easier to use than its competitor products?
The detection method is virtually instrument-free and the only requirement is a smartphone, which is supposed to be pre-owned by the potential user. All the user needs to do is buy a plastic box prized at less than INR 1000 as a one-time investment. The only consumable here is the test strip with a price about INR 2. Just one drop of finger-prick blood is required on the designated spot of the strip followed by inserting the strip into the plastic box. The user protocol is extremely simple. The Smartphone app has been developed with enough intelligence so that a single touch on the app starts the mobile camera, takes images after a fixed interval and then processes by invoking the algorithm and finally displays the result in the screen without further intervention by the user.
On the other hand, most of the existing devices in the market are expensive in terms of affordability to the rural population. It requires multiple steps to perform the test for most of the detection methods which needs skilled/semi-skilled personnel.
What are the plans to commercialise the product? When is it expected to hit the market?
We have initiated many activities and taken various measures to commercialise our innovation. In that direction, we have started our baby-steps with field trial activities for transforming this laboratory prototype to a marketable product. In parallel, we are also setting up a pilot plant for mass manufacturing of the paper-strips and the plastic box.
On the marketing front, we have signed an agreement with a company for joint manufacture and sales of the blood glucose measuring device. As for the blood hemoglobin device, we are in touch with a few potential industrial partners and possibly come up with a suitable agreement soon. We expect these two devices to hit the market within 12-18 months’ time.
The product is targeted for the poor population, but news has it that the cost will only vary a bit in the commercial market. How will it be affordable in this case?
We have developed this technology primarily to provide better healthcare to the last mile population of the society. Therefore, our prime focus is to develop low-cost technology for medical diagnosis. However, any noble intention for helping the needy of the community requires a self-sustaining robust strategy with a proper socio-economic business model, which can fulfil both philanthropic responsibility and economic needs.
To do so, we will definitely set a price for the test within the affordable limit of the poorest section. We have already calculated the fabrication cost in the lab setup is within INR 2 per strip and less than INR 1000 per box. This cost will further go down with mass manufacturing. Therefore, we strongly believe that the cost of every test will be much less than the cost presently set by the pathological laboratories. The cost of each test with our device will be lesser than the existing POC devices. For example, the present-day Hemocue device cost is approximately INR 35,000 and INR 40 per cuvette.
Who all formed your core team for the project?
We have an interdisciplinary team of scientists and doctors with varied background and expertise. A brief detail of the core team is: Dr. Satadal Saha, Doctor, Dr B C Roy Super-speciality Hospital, IIT Kharagpur; Dr. Sudip Nag, Assistant Professor, Electronics and Electrical Communication Engg., IIT Kharagpur; Dr. Shantimoy Kar, Research Assistant, Bio-medical Engineering, University of Glasgow; Sujay Kumar Biswas, Research Scholar, School of Medical Science and Technology, IIT Kharagpur; Dr. Victor Pakira, Research Scholar, Advance Technology Development Center, IIT Kharagpur; Subhamoy Chatterjee, Research Scholar, Electronics and Electrical Communication Engg., IIT Kharagpur; Sampad Laha, MS, Mechanical Engineering, IIT Kharagpur; Vinay Manaswi Pedireddi, MS, Mechanical Engineering, IIT Kharagpur; and Pankaj Goyal, Department of Biotechnology, IIT Kharagpur.
Do you have any other products in the pipeline for the healthcare industry?
We have set a target to commercialise 8-10 technologies in the next two years. Laboratory prototype for all these technologies is already developed. We are currently performing field trials and validation for some technologies such as detection of oral cancer using thermal imaging technique. This device also in the advanced stage of development for setting out the sail for commercialisation.