LivoKid platform

Kidney and liver diseases are leading public health problems worldwide. The Global Burden of Disease study reported that the estimated overall prevalence of chronic kidney disease (CKD) is ~ 8–16%. This corresponds to approximately 500 million affected individuals, of whom a disproportionate 79% (388 million) reside in low-income to middle-income countries.  This in addition to the rapid rise in the rate of deaths attributable to CKD being a 41.5% increase from 1990 to 2017, with CKD ranked as the 10th leading cause of death by the World Health Organization in 2020. Although the exact burden of CKD has to be fully accounted for, it is estimated that incidence rates in low-income countries may be as much as four times higher than in developed nations. In addition, it is estimated that people of African descent get end-stage renal disease 20 years earlier than people of other ethnicities. Liver diseases, on the other hand, account for approximately 2 million deaths per year worldwide, with roughly half due to complications of cirrhosis and the other half due to viral hepatitis and hepatocellular carcinoma. Cirrhosis is currently the 11th most common cause of death globally and liver cancer is the 16th leading cause of death. The highest percentage of regional deaths due to liver disease was seen in Latin America, Middle East and North Africa, where Egypt reports some of the highest cirrhosis mortality rates in the world.

 These statistics highlight the need for early and accurate detection of kidney and liver diseases in low and middle-income countries, as well as establishing the mechanisms for appropriate management for screen-detected individuals. However, diagnostic laboratory testing has not been a priority for health care systems with limited resources.  In addition, unreliable diagnostic testing leads to unnecessary costs in an area that already has a shortage of resources, which ultimately affects patient care and adds a substantial burden on these countries’ economies.

 The main problems hindering the complete monitoring of kidney and liver biomarkers in low and middle-income countries are related to facility logistics, available technology and patient ease of mobility.  For example, in Egypt, the central agency for public mobilization and statistics revealed that Egypt owns approximately 1900 hospitals covering all governorates where the share of the population in hospitals reached 74.2232 thousand citizens per hospital. On the technical side, the presently utilized methods need various instruments that represent a significant capital cost, require maintaining, supervising and often expensive stocks of reagents. These instruments are typically positioned close to population centers, rendering them inaccessible to rural groups in remote areas. To operate such instruments, trained, qualified and experienced personnel are needed, however, they may be overworked or unavailable. Due to health staff shortages, such tasks are frequently transferred to skilled non-medical staff. From a health facility perspective, the process of transferring blood from a patient at a remote health facility to a central laboratory is time-consuming, costly, and ultimately impracticable. Unfortunately, blood samples are often collected late or transferred incorrectly, leading to erroneous results. From the patient perspective, monitoring kidney and liver health through biomarkers analysis often means repeated visits to the health facility that in turn means repeated travel, time and costs.

LivoKid platform is a multiplex sensing platform that could monitor different biomarkers for liver and kidney diseases in non-invasive biological fluids. We offer a portable smartphone integrated, paper-based electrochemical sensor including employing potentiometric and amperometric methods for monitoring of creatinine, uric acid, p-cresyl sulphate, indoxyl sulfate and bilirubin to detect and diagnose kidney and liver diseases in low-resource settings. The smartphone application allows the storage of the measured biomarker level and provides alerts according to reference ranges of the target biomarker.  The data obtained can be sent wirelessly to healthcare providers to better inform on updated diagnostic information in a timely manner to take proper intervention regarding diagnosis, prognosis and treatment.

Currently, validated analysis of the selected biomarkers is carried out in centralized laboratories employing non-enzymatic or enzymatic spectrophotometric techniques.  These methods, however, confront several technical challenges such as; (i) non-specificity of the test due to the interferences from endogenous species, (ii) The reaction may be sensitive to temperature and pH, (iii) the toxicity of some used reagents and (iv) sample cleanup considerations. With such a high disease burden and strong demand, there is an urgent and currently unmet need for the research and development of point of care diagnostics. Our solution is a 5-in-1 electrochemical sensing device that can be introduced as a mobile app integrated portable platform achieving the features proposed in the ASSURED guidelines (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and easily delivered). Our proposed system will use saliva and urine instead of blood. Saliva and urine samples are less intrusive and can be easy to obtain, even from the elderly and groups with problems during blood extraction. The process of sample collection would only take minutes and may be repeated based on need without side effects. The collection procedure is easy and can be performed by patients at home. Thus, these fluids are cost-effective approaches for the screening of large populations over a short time-scale and therefore can serve as an ideal surrogate diagnostic fluid.

LivoKid platform is primarily designed for use in low and middle-income countries.  We plan to start with Egypt, then as a second step move forward to reach more populations that battle the risk of kidney and liver diseases. According to public health institutions in Egypt, it was estimated that liver cirrhosis and chronic kidney diseases occupy the second and seventh leading causes of death and disability, where around 8-10 million persons are estimated to have liver diseases and 2 million individuals are suffering from chronic kidney diseases.

Currently our platform is in the proof of concept/development stage.  We aim to move forward in collaborating with different agencies to conduct routine surveys that include information on the selected diseases, provide insight at the national level into disease demographics, prevalence, and risk factors. By the end of 2024, we plan to implement our sensing platform into different hospitals and institutes (ministry of health, universities) sending the results to the cloud via the mobile applications. Ultimately, our target is to provide every at-risk patient access to our platform and provide the outcome data to healthcare providers and the National Egyptian Disease Surveillance System.

In summary, our solution monitors the kidney and liver functionality over at-risk population achieving a better rate of diagnosis that strengthens disease surveillance, early warning predictive systems that slow, or halt future disease prevalence.

Currently members of the team are involved in other projects dealing with water quality in rural areas in Egypt.  Briefly, these projects involve the determination of several chemicals of emerging concern in agricultural and other wastewaters and developing strategies for their removal.  Therefore, we are involved in several water sampling and awareness campaigns in rural communities that are underserved in healthcare access.   Our close proximity to these communities helps us to better understand and fully appreciate their unmet needs.   We plan to include input from members of these communities in order to achieve buy in for the design of the LivoKid platform proposed, which we feel would be very useful and well received by these communities.

We hope to be able to make a positive contribution to alleviate some of the significant difficulties that the healthcare sectors face in developing countries through this challenge. The financial support from this opportunity would help us work on the technology and develop a prototype in order to move forward with field deployment.  While we can work on the technical aspects, we hope winning this challenge will afford us more legitimacy to overcome potential resistance from official heath organizations needed in order to make this model a success.  We think that everyone should have access to the basic healthcare services and this could be achievable by technology breakthrough that act as an influential factor for this transformation.

As smartphone technology becomes more widely available, we expect it to have a significant impact on the global deployment of sensing platforms in terms of processing, communication and social networking. Mobile phone applications are the driving force for delivering health interventions because of the widespread adoption of phones, people’s tendency to carry their phones with them everywhere.

Here, we offer basic functions that make the solution LivoKid innovative; 

• The first sensing platform that can measure five biomarkers instantaneously either in saliva or urine.
• By using LivoKid platform, few microliters of saliva or urine samples can be precisely measured.
• Unlike other used test diagnostic assays which operate as single-use disposables, our sensor can be used more than several times with minimal deviations.
• Ease of use with minimal maintenance and minimal patient training
• High performance speed.

We believe that the advantages of our smartphone-based sensing diagnostics are highly correlated with better morbidity and mortality outcomes. Some of these advantages are; (a) early-stage accurate diagnosis, (b) better communication and monitoring of patients, (c) enabling better tracking of disease outbreaks.

Goals for the next year:

 Full validation of LivoKid platform will be performed to ensure its usability throughout system development process through two steps;

a.       Sensor validation according to IUPAC guidelines in terms of calibration protocol, response time, reversibility, resiliency, stability, reliability of real measurements (accuracy and validation) and selectivity.

b.      3-level evaluation of its usability to explore potential interactions between the user, task and system; (1) Evaluating assessment (test- retest, inter-method reliability, concurrent validity, convergent validity and divergent validity), (2) Intervention evaluation, (3) Reshaping evidence generation.

Goals for the next five years:

Expanding our market to other African countries (Egypt, Sudan, Libya) that do not have access to high quality healthcare centers. We believe that as the number of users increase, the detection power and interpretation of data will significantly raise, thereby making the application more robust and able to support clinical decision making.

• Achieving our platform's analytical performance goals (Percentage or number of tests with coefficient of variation of sensor).
• Tracking the sales of LivoKid sensors.
• Monitoring the Number of users through the data cloud.
•  Survey and interview in a real-world setting.
• Number of Partnerships supporting our platform.
• reviewing internal workflows.
• Number of rural areas LevoKid reach.

Our framework is outlined as following:

Activities:

• Offering an affordable, accurate and robust sensing platform for underserved communities.
• Collaboration with stakeholders to build up plans.
• Marketing activities through local promotors, social media and public outreach campaigns.

Outputs:

• The target population has access to livokid platform.
• improving the project operation.
• Raise awareness of the population.

Outcomes:

• Enhanced access to the platform with extended range of service.
• Positive patient-provider interaction.
• strong Health Information Systems.
• Health care delivery is improved through incorporated diagnosis and identification of patients allowing rapid treatment.

Impact:

• Improve kidney and liver health through elimination of gaps experienced by low- and middle-income countries in clinical testing and access to hospitals.

LivoKid platform involves interactions of different technologies to offer a full service. The core technology is smartphone connected to electrochemical sensing platform that sent data to cloud platform through the following steps:

1.  Data Acquisition:

It is performed by LivoKid platform employing potentiometric and amperometric techniques for monitoring of creatinine, uric acid, p-cresyl sulphate, indoxyl sulfate and bilirubin, then the sensor is connected to the network through the smart phone (an intermediate data aggregator).

2. Data Transmission

The system components are responsible of transmitting patient recording to the Healthcare data ideally in near real-time. Collected data is transmitted using Internet connectivity on the aggregator via cellular data connection or smartphone’s WiFi.

3. Cloud Processing

The system comprises three components: storage, analytics, and visualization. The system is designed for offloading data storage to the cloud which poses different pros such as accessibility and scalability by patient and health authorities, besides being used with analytics and visualization. By multiple measurements and data gathering over long time, pattern recognition and machine learning algorithms can recognize correlations between LivoKid measurements and diagnoses. we believe that the analysis and presentation of this mountain of data to healthcare providers in easily visuals can provide patients follow-up in a timely manner which greatly enhance health care and save costs.

Research team members (machine learning engineers, and data analysts) will be the primary data collectors through cloud-based platform which will allow storing and analyzing LivoKid data.

We believe that EDI concept in a team makes the members more engaged and productive, and it also helps them solve problems better since people with different perspectives mostly look at challenges in a different way. We incorporate EDI by:

• fostering diversity in the composition of team (students, scholars and highly experienced personnel) with gender equality.
• enabling team members to work in an inclusive and equitable research environment.
• emphasizing equality in mentoring, training, and access to opportunities.

To ensure our team knowledge of EDI, we start offering training for different EDI topics such as inclusive and accessible workplaces, cultural safety, reconciliation, intercultural competence, bias-awareness training, antiracism, discrimination, and conflict resolution.

For financial sustainability of LivoKid, we are relying on microfinance organizations, grants, soft loans, donations, profit-generating activities and sponsoring.