Introduction

DNA Healthcare Solutions has developed an End-to-End COVID Pandemic Response Solution. The solution includes direct PPE supply lines, an on-site EUA/FDA approved 30-minute RT-LAMP COVID test, off-site 24-hour laboratory solution, IT/LIMS, smartphone reporting and other components. In short, we designed this program to be as turnkey as possible and most importantly as stress free as possible.

Tests Intended Use

DNA Healthcare Solutions test is an innovative, high throughput, portable point-of-care test that can produce results for numerous samples simultaneously in 30 minutes. The test detects nucleic acids from the SARS-CoV-2 which produces a clear colorimetric reaction to determine positive or negative infection results for active RNA. The solution combines a unique single-use test where the swabbed sample is combining with reagents, primers and viral transfer medium and then utilizes a thermal heater. Through this process DNA Healthcare Solutions can process 3,000 specimens an hour.

Our Mobile App (currently available globally on Apple and Android app stores) can also be used as an optional tool for automated infection result report generation. After analysis, the app automatically generates a PDF result report with time, date, GPS location, test ID, reaction picture and also allows users to add more pictures, custom patient information and notes. The user then can then immediately send this result report via email or SMS as needed.

Additionally, if there is an overflow of specimens, DNA Healthcare Solutions has a High-Complexity, CLIA/CAP accredited molecular laboratory, DNA Healthcare Solutions, which will process the specimens. In the event that specimens are to be sent to DNA Healthcare Solutions, specimens will be packaged and shipped overnight according to CDC guidelines. The laboratory will report all specimens within 24-hours. DNA Healthcare Solutions has capacity of testing 18,000 COVID specimens daily.

Obtaining and Communicating Laboratory Results Within the Timeframe of Scope of Service

Our HIPPA compliant, cloud-based, Laboratory Information Management System (LIMS) includes a free Mobile App which provides a positive or negative COVID-19 result within 30-minutes after taking the test. With the COVID-19 test being smartphone-based, it enables us to auto-generate reports with time, date, pictures, virus information, GPS location, and more. The smartphone-based COVID-19 testing solution is available on Apple and Android platforms. Users are also able to access their results on our online portal. Each passenger will get a text message and email notification that their results are available with instructions on how to log into the online portal. All results are reported hourly to the appropriate public health authorities and CDA through the LIMS.

Conclusion

We are set up for the next Pandemic to create and run new panels on the same platform whatever that may be. According to Thermo Fisher, we have the most comprehensive Infectious Disease Panel the last four years running, which includes COVID-19, Malaria, Ebola and H5N8.

Widespread, secure and reliable testing is a proven, effective way to combat the spread of COVID-19. We recognize that this is a constantly evolving situation that will require a trusted team to deliver. Our collective experience backed by our rapid time to market will give you the crucial data and resources you need to track the spread of the virus and contain it.

DNA Healthcare Solutions delivers experienced, best-in-class healthcare, data and operational services to ensure your COVID-19 testing is executed with the highest levels of professionalism, flexibility, security and safety.

We want to thank you for taking the time to review our End-to-End COVID Pandemic Response Solution. Please feel free to contact us with questions or discuss our programs.