Teams must produce tests that cost less than $15, including any material and reagent costs.
Teams with molecular/viral assays must achieve levels of sensitivity, specificity, and limits of detection that are close to, or greater than, clinical performances of current tests on the market. These are often >95% sensitivity and specificity, with a limit of detection (LoD) from 0.01-100 copies of virus per microliter, where lower LoD is better. However, these are guidelines, and all tests will be judged across to these metrics as well as all others.
Yes, the maximum turnaround time is 12 hours from sample to result. However, teams should strive to reduce turnaround times as much as possible.
Teams are permitted to sell their tests during the competition. However, teams must provide their tests to their on-site testing partners free of charge. Teams should ensure that they have enough testing supply to sufficiently perform on-site testing during the Pilot Round of the competition, including enough additional supply to account for product loss and other issues that may render tests inoperative.
English is the only language required during the competition. However, we encourage teams to create instructions in as many languages as possible as some of the pilot sites in the Pilot Round may be international.
No. Because the tests will be used for screening purposes (not diagnosis) and will not report patient-specific results (i.e. “participant A was positive for COVID-19”), FDA EUA authorization is not required. The tests in this competition can be classified as "Research Use Only" (RUO). Positive results would be reflexed (referred) to an official clinical test with the appropriate certification (i.e. CLIA) required for clinical diagnosis.
No. Unfortunately, XPRIZE cannot assist with getting teams’ tests covered by insurance providers.
No. Unfortunately, XPRIZE cannot assist with manufacturing or supply chain logistics. Teams are responsible for sourcing their materials and building their supply chains. However, XPRIZE will host a series of webinars where teams can ask each other for advice on these issues.
No. Teams are responsible for shipping their own test kits to clinical lab partners and ensuring they are delivered on time.
All data must be anonymized before being sent to the XPRIZE Data Collaborative.
Test results data should be sent directly to the XPRIZE Data Collaborative. Teams will be given a template file with instructions on how to input and send the data.
The only information that will be publicly released is the protocols, standard operating procedures, and validation results – information that is required for FDA EUA authorization, which is ultimately made public.
Teams will not be required to release intellectual property (IP), secrets, or other information that gives them a competitive advantage regarding the commercialization of their innovations. However, teams must include the cost of any and all proprietary components into the cost of their testing solution.
The deadline to register is September 8, 2020 18:59:59 UTC.
Competing in an XPRIZE is an exciting journey that often requires a commitment of time, expertise, and resources. Registration fees are required as a simple qualifier to ensure competitors will be able to obtain the appropriate resources to fully compete. All fees collected are used to support XPRIZE teams.
We welcome partners throughout all phases of the competition, whether you want to help recruit teams, support team success, secure an XPRIZE speaker or expert for your event, help scale winning solutions, or assist with testing operations. Contact [email protected] to learn more.
You can also follow the competition at xprize.org/covidtesting.