REDUCED COST

ELISA READER

INFECTIOUS DISEASES

MEMBERS:

CHAITY CHAKRABORTY

NISHAT TASNIM

LABIBA ISLAM SALSABIL

MD ASIB RAHMAN

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BANGLADESH UNIVERSITY OF ENGINEERING AND TECHNOLOGY

DEPARTMENT OF BIOMEDICAL ENGINEERING

Problem statement

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RDT Test kit

False positive/ False negative result

Wrong treatment

Accuracy: 75-80%

Doctor suggests Elisa

Elisa reader not available , samples sent to IEDCR/BSMMU for testing

Reports get delayed by 2/3 days

Possibilities of sample contamination

Increase in price of test

Accuracy : 95 – 98%

Situation 1:

Situation 2:

ELISA – Enzyme linked immuno- sorbent Assay

solution

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We are in a mission to make a reduced-cost ELISA setup to eradicate the problem of wrong treatment due to false positive/false negative results and make highly accurate Elisa tests accessible for every citizen at a very low-cost saving their lives, money and time.

So, our solution is to make a reduced-cost ELISA reader which will be

• Accurate
• Easy to operate 
• Providing access to accurate diagnosis to all classes of people.

Commercial Elisa Reader

Reduced cost Elisa Reader

2 lakhs – 50 lakhs BDT

Prototype: 4000 BDT/34 USD

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Design Description

This is how our final product looks like!!

Design Components

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• Our final design incorporates a Dimmable 5600K USB video light with a wavelength filter to target disease-specific wavelengths. 
• The light traverse samples, reaching the GY-30 (BH1750) light intensity sensor, linked to an Arduino UNO. 
• Absorbance is displayed on an LCD/serial monitor, calculated using internal code grounded in Beer-Lambert's Law. 
• A manual filter paper changer is included. 
• Our device's wavelength range: 380 – 740 nm. 

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• Disease presence is determined via absorbance compared to predefined cut-off values:  
• Absorbance < Cut-off value -NO DISEASE 
• Absorbance > Cut-off value -DISEASE PRESENT 
• Higher absorbance signifies greater disease severity. 

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How this design works?

Risk Analysis:

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• Disease samples: Timely testing after sample preparation is crucial to avoid contamination.
• Light source: Regular intervals between tests are necessary to avoid overheating of the light source.

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Novelty that we're adding to this design:

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• Our novelty lies in-
• Cost reduction
• Light-weight and portable design
• Elisa reader-Spectrometer dual properties
• Our device can be used for diagnostic and laboratory purposes in low-resource settings.

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Major Technical Challenges and how we solved them

Experimental Study

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During experimental stages, we've tested our device using Curcumin samples and at the prototype stage, our device could detect the changes of concentration for tested Curcumin samples.

Testing Curcumin samples with prototype

Clinical Study for Evaluation

Testing the device with proper samples of HBsAg positive and negative patients-

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Sample Preparation

Test kit used for ELISA test of HBsAg

Includes:

• Positive and negative Control
• Enzyme conjugate
• Buffer solution
• Color A and Color B
• Stop solution

Samples after adding Enzyme conjugate

Stirring the samples at 37°C

Adding Color solutions A & B

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Sample Preparation

Positive samples becoming yellow after addition of Stop solution to the wells. Negatives samples remain colorless. 

We wait for 1 hour(30 mins with stirring) after Enzyme conjugate, the wash the solution using was buffer solution 5 times.

After washing away the test samples, we then add color solutions to the remaining bound antigen-antibody complex inside the wells, for better visualization.

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Video Demonstration of the test procedure!

To watch a detailed video demonstration, click here

Results Analysis

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We tested more that 150 HBsAg samples and obtained the results for our device.

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Statistical Analysis of Results

Figure: Confusion matrix showing the TP,TN,FP and TN

Here, we assumed that Commercial ELISA Reader gives 100% accurate results, so no false positive or false negative results. Whereas there are some FP and FN results for out ELISA Reader. 

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Statistical Analysis of Results

Figure: Box plot comparing results from our ELISA reader and Commercial ELISA Reader

Assuming the data collected from BSMMU is 100% accurate, this box plot shows our range of True positive, True negative, False positive, False negative.

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Statistical Analysis of Results

Performing Mann-Whitney U test

For analyzing statistical significance of the results, we performed the Mann-Whitney U test for 95% confidence interval. For this level of confidence, if the p-value is less that 0.05 than we can say that there is a statistically significant difference between the two groups data. 

From the test, we found our p-value to be 0.414, much greater that 0.05. Such higher p-value is suggesting that there is not enough evidence to conclude a significant difference between the data from our device and ones from the commercial ELISA Reader.  

Environmental Impact and Sustainability

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TARGET MARKET

Our ELISA test setup will target individuals who are affected by infectious diseases and require testing for accurate diagnosis.

Over the past five years, there have been 175,259 

reported cases of dengue outbreak .

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Financial analysis

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• In the perspective of Bangladesh, our cost-analysis, including DGDA approval fees, indicates that we will reach the break-even point after selling 73 products. 
• Our sales target is 100 products in the 1st year, increasing by 50 units annually.

With a 15% profit per unit in year 1 and 28.33% profit per unit in year 2, our fixed per unit MRP or Revenue will be set at 20,000 BDT. For detailed profit margin calculations, please refer to the provided link.

Competitive analysis

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Future Plan

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Some appreciations from respected Dr. Srebash Paul sir,�Contagious Diseases Hospital 

"It is a great opportunity for me to congratulate Nishat, Labiba, and Chaity for their extraordinary efforts. They approached me a few months ago with some brilliant ideas for working on infectious diseases. I also share my views with them. It was beyond my imagination what they did in reality. I firmly believe that this ELISA device may bring revolutionary change to our medical industry. I think this device will be very helpful for the health sector in low-resource areas like Bangladesh. I am excited to see the final outcome of this project. I am confident God will bless them with a very bright future."

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Acknowledgements

To all the teachers, mentors of our faculty and doctors who have helped us immensely throughout our journey.

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Thank you!

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# for any references  click here.

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