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Development of Smartphone Integrated Generic Microfluidic Devices for Rapid, Portable, and Affordable Point-of-Care Diagnostics

Primary Information

Domain

Environmental Science & Climate Change

Project No.

4429

Sanction and Project Initiation

Sanction No: 35-10/2016-TS-I

Sanction Date: 27/02/2017

Project Initiation date: 24/03/2017

Project Duration: 36 months

Partner Ministry/Agency/Industry

Indian Council of Medical Research (ICMR), Department of Health Research

Ministry of Health and Family Welfare, New Delhi.

Principal Investigator

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Suman Chakraborty
Department of Mechanical Engineering, IIT Kharagpur

Co-PIs

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Soumen Das
School of Medical Science and Technology, IIT Kharagpur

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Chandan Chakraborty
School of Medical Science and Technology, IIT Kharagpur

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Amit Agrawal
Department of Mechanical Engineering, IIT Bombay

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Ashis Kumar Sen
Department of Mechanical Engineering, IIT Madras

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T S Chandra
Department of Biotechnology, IIT Madras

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Dr. Anil Tarigopula
Consultant Pathologist, Apollo Hospitals, Chennai

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Sudip Nag
Department of Electronics & Electrical Communication Engineering, IIT Kharagpur

Host Institute

 

Scope and Objectives

Development of microfluidic devices for quantification of blood parameters

To realize bio-sensors for electrical signal generation and its integration with microfluidic platforms

Development of smartphone-based diagnostic applications/ software in the Android platform to analyze the biochemical/ electrical readouts

Validation of the results with the pathological/clinical references.

Deliverables

Low cost microfluidics-based diagnostic kits for dengue diagnosis

Paper-based microfluidic biosensors for diagnosing diabetes and anemia as two case studies

Smartphone attachment for stable image acquisition of microfluidic device

Android app with user-friendly interface to acquire and process captured signals for disease detection

Scientific Output

We have explored different blood plasma separation techniques for point-of-care applications like agglutination process, membrane based separation, salt based separation, etc. (IIT KGP)

By conducting several experiments, we have studied about the capillary filing dynamics through filter paper . (IIT KGP)

We have developed an user friendly smartphone app for colorimetric image analysis . (IIT KGP)

We have developed an understanding of the electrical properties contributed by various blood components such as whole blood, plasma, serum, and red blood cells are being investigated to develop an affordable paper and pencil biosensor for early diagnosis of diseases (IIT KGP)

We have developed a self powered standalone capillary based blood plasma separation device that provides 2.0 microlitre of plasma in 5 min. (IIT M)

We have completed a detailed literature review on micro devices capable of delivering platelet-rich plasma. This effort has led to an (invited) review article published in the Journal of the Indian Institute of Science. We have also developed the first version of a microfluidic device for delivering platelet-rich plasma. (IIT B)

Results and outcome till date

1. We have explored different blood plasma separation techniques for point-of-care applications like agglutination process, membrane-based separation, salt based separation, etc. (IIT KGP)
2. By conducting several experiments, we have studied about the capillary filing dynamics through filter paper. (IIT KGP)
3. We have completed fabrication of smartphone based paper sensors for colorimetric detection and quantification of anemia and diabetes from human blood (IIT KGP).
4. A 3D printed portable smartphone enclosure has been developed for integration of the paper sensor with the smartphone and stable image acquisition . (IIT KGP).
5. An android based smartphone app has been developed for colorimetric analysis of the acquired images and for subsequent result display (IIT KGP).
6. We have completed 2 field trial activities of our smart phone-based device. The first one at Salboni Super Specialty Hospital, West Bengal and the other one at a rural health kiosk at Barhra, Birbhum, West Bengal . Till now, we have tested more than 100 glucose and 100 haemoglobin samples .The accuracy of our device is well within the limits prescribed by WHO. (IIT KGP)
7. Technology transfer on Integrated blood plasma separation device for glucose detection on a single paper platform has already been agreed upon. Commercialization process for this device is currently in progress by collaborating with different (IIT KGP)
8. We have developed 'Medcolorimeter', a generic colorimetric signal detector for easy and rapid detection of biomarkers from blood, urine and saliva (IIT KGP).
9. We have participated in TechEx Exhibition at IIT Delhi on 4th August, 2019, where we have successfully demonstrated our innovated products on glucose detection, haemoglobin detection and Med colorimeter.
10. We have fabricated an inexpensive, rapid, bio compatible paper and pencil device for anemia detection using the impedance spectroscopy technique. Currently we are investigating the difference between plasma and serum of normal and diseased sample on paper and pencil device (IIT KGP).
11. We have developed a self powered standalone capillary based blood plasma separation device, a PDMS, micro channel that provides around two micro litre of plasma in five min (IITM).
12. We are developing the lateral flow assay to detect dengue NS1 antigen from sample blood based on colorimetry. Also, a surface plasmon resonance (SPR) based optical system is currently being developed for the detection of NS1 antigen. (IIT M)
13. The first version of a microfluidic device has been developed and fabricated by us. Initial results suggest that the developed micro device is able to meet the enrichment requirement of 3-8 fold increase in number of platelets with respect to the input sample. We are also performing biological tests on the obtained platelets to ensure that platelets are not activated upon passing through the micro device. We are also trying to improve the purity and yield of the obtained platelets. (IIT B)

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Societal benefit and impact anticipated

A major part of rural population in the developing countries are still deprived of quick and reliable healthcare amenities due to the improper infrastructures .The inhabitants, have to mainly rely on diagnostic centers in faraway towns. A lot of effort and time is required to take a patient to such diagnostic center for testing. By the time the pathological result of the medical tests are received, in many cases, the patient may reach a very severe condition. Along with this , the increasing cost of medical tests is also a major concern for the common mass. In this scenario, a portable, rapid and point-of-care technology for bed-side testing is extremely valuable, especially in the context of rural society of the developing countries.
Through this project, we are developing point-of-care diagnostic devices which give rapid and reliable results from a single drop of blood, even in rural resource-limited settings. Along with this, our device will be extremely low-cost , simple and can be operated easily without any trained personnel. Hence, our aimed diagnostic device has immense potential to improve the condition of rural healthcare scenario in the developing nations.

Next steps

We will complete further field trials at Salboni hospital for validation of glucose and hemoglobin detection process. By next month, we have planned to complete validation of at least 50 more glucose samples and 30 hemoglobin samples.

We will carry out filed trials at rural health kiosks to test the adaptability of our device in conditions of extreme climate and poor infrastructure.

We will mobilize the commercialization process of our device and scale up mass fabrication by suitable tie ups with different MSMEs.

We will concentrate on addressing regulatory approval issues.

Publications and reports

1. Laxmi, V., Tripathi, S., Joshi, S.S., Agrawal, A., Microfluidic techniques for platelet separation and enrichment: a review, Journal of the Indian Institute of Science, Vol. 98, pp. 185 200, 2018.
2. Sujay Biswas, Soumya Bandyopadhyay, Shantimoy Kar, Nirmal Kumar Som and Suman Chakraborty 'Anemia Diagnosis on a Simple Paper-based Assay' bioRxiv, 439224

Patents

We have already filed the following two patents regarding the glucose and haemoglobin detection devices:
1) System for estimation of plasma glucose by integrated paper-based device and method thereof. (File number: 201931030435)
2) Smartphone based blood haemoglobin estimation system (File number: 201931030430)

The following patent is under the process of filing:
1) MedColorimeter - A device for colorimetric detection of bio and non-bio analytes

Scholars and Project Staff

At IIT KGP,
1. Subhamoy Chatterjee, PhD under Prof. Suman Chakraborty.
2. Sampad Laha, MS under Prof. Suman Chakraborty
3. Vinay Manaswi, MS under Prof. Suman Chakraborty

At IITB,
1. Vijai Laxmi, PhD under Prof. Amit Agrawal

At IIT M,
1. 1 Project Associate has been appointed under Prof Ashis Kumar Sen.

Challenges faced

Any other relevant information

Technology transfer on Integrated blood plasma separation device for glucose detection on a single paper platform has already been agreed upon. Commercialization process for this device is currently in progress.

Other information

1) Technology transfer on Integrated blood plasma separation device for glucose detection on a single paper platform has already been agreed upon. Commercialization process for this device is currently in progress.
2) Below are some links of news on our innovated devices that recently published in various media.

Financial Information

  • Total sanction: Rs. 31672800.00 lakhs

  • Amount received: Rs. 23716000.00 lakhs

  • Amount utilised for Equipment: 4900000.00 lakhs

  • Amount utilised for Manpower: Rs. 3516631 lakhs

  • Amount utilised for Consumables: 2123657.16 lakhs

  • Amount utilised for Contingency: 782248 lakhs

  • Amount utilised for Travel: Rs. 238039 lakhs

  • Amount utilised for Other Expenses: Rs. 4076168.84 lakhs

  • Amount utilised for Overheads: 4187023 lakhs

Equipment and facilities

Equipment purchased:

a) High-End GPU workstation (1 NOS at IIT KGP) b) Workstation ( 1 NOS at IIT B) b) 3D printer ( 1 NOS at IIT KGP) c) UV-Vis Spectrophotometer (1 NOS at IIT KGP) d) Spectrometer ( 1 NOS at IIT M) e) Weighing balance ( 1 NOS at IIT M) f) PC ( 1 NOS at IIT M) g) DIC Prism Slider (microscope optics) ( 1 NOS at IIT M) h) Precision Metering Instrument ( 1 NOS at IIT M) i) Vacuum aspiration system ( 1 NOS at IIT M) j) Processor for Work station (1 NOS at IIT KGP) k) 32 GB DDR4 RAM (4 NOS at IIT KGP) Facilities created: i. Fabrication of the paper-based microfluidic device at IIT KGP. ii. Smartphone adapter fabrication using 3D Printer at IITKGP iii. Resource for image processing facility at IITKGP iv. Facility to handle blood at IITB and IIT KGP

 

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