The at-home rapid molecular Detect Covid-19 Test is said to combine the sensitivity of a PCR lab test with the convenience and scalability of a typical rapid test
Detect’s rapid PCR-quality at-home Covid-19 test uses a comfortable nostril swab to make testing an easy part of the daily routine. (Credit: Business Wire)
Health technology firm Detect has secured an emergency use authorisation (FDA) from the US Food and Drug Administration (FDA) for its over-the-counter home use Covid-19 test.
The at-home rapid molecular Detect Covid-19 Test is said to combine the sensitivity of a PCR lab test with the convenience and scalability of a typical rapid test.
Detect’s advanced technology enables to detect SARS-CoV-2 at lower viral loads than antigen tests, thereby facilitating early detection to minimise pre-symptomatic spread.
Suitable for aged above two years, the Detect Covid-19 Test is designed for use entirely at home in one hour compared to traditional laboratory testing that consumes time.
According to the company, the Detect Covid-19 Test has shown a 97.3% overall agreement when compared to a highly sensitive PCR test in clinical studies.
It demonstrated a 90.9% sensitivity and 100% specificity when the test results were interpreted correctly, said the company.
The Covid-19 test is developed for use in schools and workplaces for regular screening programmes.
Detect founder Dr Jonathan Rothberg said: “The Detect Covid-19 Test brings laboratory accuracy into the home, helping to mitigate Covid-19 transmission and make everyday activities safe and anxiety-free again.
“As a complement to vaccines, highly accurate rapid testing will be critical as the pandemic becomes endemic. We developed the Detect Covid-19 Test to help people return to doing the things they love with the people they love in the safest way possible.”
Through mobile app-based instructions, users will be able to complete the test-taking process for the Detect Covid-19 Test.
The company is also developing an electronic travel pass system with an add-on telehealth service to make the results validated for travel and event entry.
The test finds and amplifies small segments of viral RNA with a limit of detection of 313 copies per swab. It will help identify all currently circulating variants of concern and variants of interest, including Delta.