Tests have been validated using clinically positive and negative patient samples. (Specificity 97.7% to 100%) Test results for accuracy can be provided upon request (for account holders only).
We currently have one USA manufactured test. All others are manufactured in China and subject to both the Chinese and USA FDAs. All manufacturers are approved by the Chinese FDA and three have received EUA authorization. The others currently hold the USA FDA’s non-EUA status. (Registered and awaiting FDA clearance)
These tests can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Many recent studies show that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important.
Although the test is ideally suited for hospitals, clinics and test laboratories, they can also be effectively deployed in businesses, schools, airports, train stations, cruise ships or other places where crowds are gathering. Rapid test kits have the potential to become a compelling force in the fight against this global threat.
Watch the video below to see how the test is performed: