The Promise of IIT’s One-rupee Diagnostic Device

By Ikyatha Yerasala

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A group of researchers from IIT Kharagpur, led by Professor Suman Chakraborty have developed a low-cost diagnostic device which can estimate blood parameters by using a single drop of finger-prick blood. The team, that aims to tackle the prevalent problem of anaemia in the country, talks to Ikyatha Yerasala about their device and more…

 
 

A pregnant lady in rural West Bengal is feeling rather weak and is unable to figure out the reason for her fatigue. She’s also utterly terrified as she isn’t able to find easy access to a diagnostic centre or a doctor who can reveal to her the cause of her exhaustion. Little does she know that she may be anaemic, and could be iron deficient too. IIT Kharagpur’s latest invention could be a blessing for pregnant women like her who don’t have easy and affordable access to blood testing. With anaemia in pregnant women being a major factor associated leading maternal and foetal complications, a group of inventive researchers from IIT Kharagpur led by professor Suman Chakraborty decided to create a distinctive low-cost diagnostic device that uses a single drop of finger-prick blood to estimate blood parameters. With India having a very high percent of women suffering from anaemia; particularly in the reproductive age group (51%), iron-deficiency being the leading cause, professor Chakraborty and his team recognised the importance of an easy-to-use affordable device. “We started establishing and operating E-health clinics in remote rural areas in West Bengal and encountered many women clearly suffering from clinical anaemia; but had no access to diagnostic tests except at a huge cost and inconvenience of travelling far to a diagnostic centre. This motivated us to start working on a device that would be easy-to-use, work accurately under rural circumstances, is affordable and did not need highly-skilled operators,” says the team.

Distinctive design

The team has developed low-cost paper strips which can estimate various blood parameters (Glucose, Haemoglobin etc) by using a single drop of finger-prick blood. Integrated with a smartphone device for analytics and readout, the 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. It’s 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 colour change that corresponds to the quantification of a blood parameter such as glucose (sugar) and hemoglobin. “While it’s designed to be generically applicable for detection of any diseases that produces such colour signals in a body fluid (such as blood, urine, saliva), the device has been extensively validated for the specific determinations of blood glucose and haemoglobin, by comparing with the results from expensive benchmark laboratory setups,” they state.

Also, 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 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 whereas 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 whole blood glucose,” share the group of researchers have also tested the device for blood haemoglobin level estimation, which is 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 colour signal. Compared to others, 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. We have adopted a detection method which is virtually instrument-free and requires only a smartphone. The user protocol is  simple; requires a single drop of finger-prick blood and a drop of reagent on the paper-based reaction chamber,” reveals the team.

Weather test

To ensure that the device can stand extreme weather, the team set out to test their invention in three environmental conditions including extreme ones. The first test was done tested with a large number of blood samples in a controlled lab environment and compared the result with gold-standard pathological results. “Next, we performed our first field trial at the Salboni Super Speciality Hospital in West Midnapore district of West Bengal about 160 km away from Kolkata. The performance of the device was very impressive without proper laboratory setup in uncontrolled temperature and humid condition. The second field trial was performed in a village Barhra in Birbhum district of West Bengal. We set our camp in a primary school in extreme environmental condition with heavy dust, high humidity (>70%) and soaring temperature (>36°C) which can be termed as extreme point-of-care situation. For both glucose and haemoglobin estimation, the result of our devices was closely matching with the result obtain by Accuchek and Hemocue devices.” The device, in its validation stage, has been used in one of the rural hospitals, while commercialization for open use is under process.

Changing the face of diagnosis

While the device is being hailed for being low-cost, Professor Chakraborty and his team insist that the focus should be taken away from the single-point agenda of ‘low-cost’. “The issues at play are – ease-of-use, simplicity, operability under difficult rural weather conditions, accuracy, less requirement of consumables, easy maintenance; and then, finally, affordability. These conditions are to be achieved through deep science research and innovating a whole new way of diagnostic tests that will deeply penetrate into the mass market and create access to healthcare for the wider Indian population. 80% of current diagnostic technologies are imported at a huge cost which require highly skilled staff, complex consumable requirement and accurate climatic conditions to work. This is why over 70% Indians do not have access to healthcare. Our device will transform the health eco-system by creating access and affordability, facilitating earlier disease detection and improving societal health indices,” they maintain.

 
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