Purdue iGEM Page

Proposed Implementation

End Users of cArgo: 2020 and Beyond

With the coronavirus pandemic, COVID-19 testing has been a large concern across the globe. Patients that experience symptoms of the virus don’t specifically know if they have COVID-19, or if they’re experiencing symptoms of a less malignant illness such as the common cold or the flu. People that want to obtain an answer to this question often times have to look outside of their home to get a Covid test. These tests are usually time inefficient (scheduling/lack of time slots) and uncomfortable (nasal swabs) for the patient, which leads to many people not getting tested and risking the possibility of infecting other people. The need to make coronavirus testing an easier process for the general public led our team to develop a device that allows users to test for coronavirus in the safety of their own home in a time efficient, comfortable, and simple manner. Users can deposit a saliva sample into our device, which will then give a positive or negative result in under an hour.

Benefits of Rapid, Saliva-Based, Point-of-Care Testing

This device will allow the general public, our target group, to have access to testing without having to stress about appointments, uncomfortable testing procedures, or going into the public not knowing if they have to quarantine. Due to the unique ability of our diagnostic device to operate outside of lab conditions, our device is primarily intended to be used to rapidly screen individuals for the indicated pathogen of interest. The complex nature and the potential risks associated with working with the materials contained in the device means that the device will likely need to be operated by a trained professional and is thus more suited for commercial or public health applications. This would include use in airports to prevent the spread of infectious diseases or in hospitals to protect vulnerable populations. However, in order to allow a larger fraction of the general public to use our device, we are hoping to release a simpler, more user-friendly version of our hardware in which our biologics operate similarly.

Future Implications

As the pandemic begins to die down along with the demand for testing, cArgo's function may seem less relevant to public health. However, we developed cArgo as an adaptable nucleic acid-based testing assay with an associated program that can be used by diagnostic researchers to quickly design compatible biological parts to detect a viral pathogen given a characteristic nucleic acid sequence. It is not at all limited to SARS-CoV-2. In the future, we propose that cArgo can be utilized in households everywhere to allow for quick symptomatic testing of any viral infection. This reinforces that our target demographic stays the same: the general public.

cArgo Safety Concerns

Although cArgo does not use volatile chemicals, the dominant safety concern related to our device is exposure to potentially hazardous reagents and biological samples. There are some buffer solutions inside the chip, and it is important that nothing leaks as it may be harmful to the user or the user's surroundings. Moreover, the saliva samples that are collected are potential biohazards, so used devices should ideally be collected, handled, and disposed of by trained medical professionals.

cArgo Regulatory Considerations

To distribute our final product, it must first be approved for sale by regulatory agencies, such as the FDA. In 2020, we talked to Frederick Gates who worked on regulatory affairs at Pfizer for 15 years. He gave us advice on how to make our device meet government regulations. The FDA is one of the key players in regulating medical devices and diagnostics. Under standard FDA review, it would take about 12 months for a diagnostics device to enter the market. The FDA CFR Title 21, Section 820 outlines the requirements for medical devices. From this interview, we made sure to be more aware of FDA regulations and make sure our device follows them as well as introducing a control into the design of our chip and conducting validation assays. The summary of the requirements of a medical device according to FDA regulations can be found below. We incorporated Gates's advice into the original design and will do so for any subsequent redesigns.

References

https://www.propublica.org/article/emergency-medical-responders-have-lacked-guidance-and-are-stretched-for-supplies-and-personnel-to-combat-coronavirus

https://www.nytimes.com/interactive/2020/03/17/us/coronavirus-testing-data.html