1.

1. All the individuals on the team are focusing more on being able to complete the main lab procedures independently
2. Personally, I have been taking on more responsibility the longer I have been on the team. Currently, our lead senior in the lab, Maria Lancia, is certifying me to teach the procedures to others on the team, so cumulatively, we can be more efficient in the lab.
3. Additionally, I have become much more adept at working as a team since joining the Sickle Cell Group. Collaborating on presentations and grant papers have allowed me to adapt these skills. 
4. I have always been a keen listener to others ideas, but I have realized to trust my own ideas more as well.
5. I have become more effective in problem solving and problem framing as well. Finding a way towards approaching and solving complex problems is a key skill in the lab, while making presentations and more.
6. Each member of the team has been assigned to present about what the project is about, lab protocols, purpose of our project, and/or protocols to external systems we use like ImageJ. We do this in our weekly meeting with Professor Cheng and our senior member Maria to ensure that everyone is on the same page and absorbing this information.
7. All of our subgroups have to be on the same page to efficiently deliver results. For example, analyzing test line intensities, we need to make a lab schedule, go to the lab and run the experiment while following protocols, then send them to the ImageJ team for analysis.
8. I have realized the importance of having background cultural knowledge. In high school, I modified a “Hippo Roller” to create electricity while being rolled to purify the water inside. I did not take the cultural aspects when prototyping the implementation of this device.
9. Additionally, I have realized that to understand the true scope of our project, we need not only read previous articles from our team, but also previous articles regarding Sickle Cell Anemia and Lateral Flow Devices.
10. I have also improved on my procrastination since joining the group. Many of my team members like to work ahead of schedule, so they have helped me be accountable for completing my work earlier.

2. 

Roles:

Our team’s role is to successfully develop and administer a lateral flow immunoassay test strip in order to diagnose sickle cell disease (SCD) in Sierra Leone. The organizations and individuals (listed in “Relationships” below) identified the absolute need for a low-cost, screening device and have shown interest in what our solution proposes.

Relationships:

The project has gone through multiple stages of prototype designs to the design we have today with our PI, Professor Cheng, and GSIF coordinator, Khanjan Mehta. The team has also validated this device and has received feedback through the connections we have established with World Hope International, Sickle Cell Care Awareness Network (SCCAN) and Dr. Ranju Gupta together with partnerships within Sierra Leone including Masanga Hospital and Dr. Cheedy Jaja. We would also like to acknowledge Lehigh Global Social Impact Fellowship (GSIF), Lehigh Technical Entrepreneurship, Lehigh Valley Health Network and VentureWell E-team for bringing us this far along our work.

Procedures/Work in Progress as of Now:

So far, the team has a successful diagnostic test strip established. The novel device schematics, the “E-junction”, is capable of running on only a single drop of blood without a dilution step. The process is efficient and only takes 15 minutes to run. Currently, the diagnostic device is being tested using purified HbA and HbS, and also HbA blood samples from a local blood bank in Bethlehem. Our team has been awarded the Stage 1 grant of $5,000 offered by VentureWell E Team, the Davis Foundation’s Peace Prize, been selected as finalists for the Global Health track in the John Hopkins Healthcare Design Competition, invited to publish our year’s IEEE article onto a special issue indexed by SCOPUS called Multidisciplinary Sciences and Engineering organized by Advances in Science, Technology and Engineering Systems Journal (ASTESJ), received acceptance for this year’s IEEE GHTC Conference, and received acceptance for BMES 2020 Conference. We are currently under review for the NIH Tech Accelerator Challenge (NTAC) and DEBUT by VentureWell.

In the lab, we are currently running optimization tests to maximize the test line intensities. ImageJ software is used to quantify the test line intensities from these direct binding tests. Variations of the test line position on the test strip, as well as the location of one test line with respect to another test line, are being studied. Three test lines were printed with the HbA antibody on to the test strip at different locations relative to the absorbance pad. By doing this, we are seeing if there are possible indicators that inhibit or decrease the test line intensities. Test line intensities are conducted for the current prototype in order to measure for accuracy analysis with ImageJ software.

Current Goals and Milestones:

As our lateral flow device is improved and developed over time, our team plans to write publications. To do so, we are looking into journals to understand what our targeted audience wants to see from our research. For instance, in-depth concepts about our diagnostic device’s design, outcome, specificity, and sensitivity. Our experiments will be planned based on our target journal and two main focuses discussed in our publication will be design versus clinical tests versus field considerations. Some publications the team is considering as of right now are Lab on the Chip, and the Journal of Hematology. 

Another goal the team is looking at is quality control. As a team, we must figure out the shelf-life and storage of the test strips (by itself or with the blood sample + running buffer + antibody). Possible storage we are looking into is the development of a casing. Other aspects to consider are also the effects of humidity, temperature and other possible constraints (dehydration). 

After establishing quality control, we are currently working on optimizing the production of test strips. An automated repetitive system for the printing mechanism has been slowly developed alongside the diagnostic device. The system will consist of a conveyor belt and functionality programmed by an Arduino with Matlab. The goal is to create a motor-driven belt in which it could transport the strips of Nitrocellulose membranes down the conveyor. The Nitrocellulose membrane strips will reach a point, where it will trigger a light sensor (Photocell or Light Dependent Resistor Sensor), causing a chain reaction to enable an attached syringe press (propped up by a 3D printed stand) to pump the antibody solution onto the strip.

Next Steps and Larger Goals:

We aim to return to Sierra Leone in August of 2021 in order to conduct the alpha testing phase of the diagnostic device. To conduct this testing, we aim to collaborate with Dr. Jaja who has IRB approval to run studies on current SCD screening devices, SickleSCAN®. As we work under his guidance, an estimate of 10-20 devices will be tested to validate its usability. 

We are planning to launch our product in Sierra Leone in Summer 2023. By cross-referencing a population density map and a map of all the public hospitals in Sierra Leone, we have constructed an ordered list of hospitals where we will introduce our device. One year after launch, we expect to be implemented in 10 densely populated hospitals encompassing many areas of the country. Two years after launch, we expect to be in 25 hospitals, and three years after launch, we expect to be in at least 50 hospitals diagnosing 75% of the newborns. 

The device will be implemented into the standard operating procedures (SOP) of care in target hospitals where the hospital staff will issue the single-step test for SCD and Sickle Cell Trait (SCT) when a child is born. 

Five years from launch, the venture will be sustainable and autonomous from our input as we will shift our focus to look at the intellectual side: strategic gaps, false positives/negatives. The project will be absorbed into the Sierra Leone Ministry of Health which will continue screening for SCD/SCT for newborns because they have the authority and funds to sustain our venture.