THE ASSURE-100 RAPID COVID-19 AT HOME TEST KIT

Product Description

The ASSURE-100 Rapid COVID-19 Home Test is indicated for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen from direct shallow nasal swab samples, and for 'over-the-counter™ or at-home use, without the need for a prescription from a healthcare provider.

Rapid antigen tests are less expensive and faster than traditional polymerase chain reaction (PCR) tests, offering people an easy and low-cost way to protect family members, classmates, and co-workers during, especially important for the holidays. At-home rapid testing makes it possible for individuals to know their infection status quickly and monitor health over time.

Even as we see normal life and activities return in our communities, we™re not out of the woods. Across the country, many are still coping with COVID-19 impacts. As we enter the winter months ” with flu, respiratory syncytial virus (RSV), and COVID-19 on the rise ” we encourage everyone to boost their COVID-19 vaccination status to protect yourself and your family.

The FDA EUA for ASSURE-100 home tests enables serial asymptomatic testing, meaning that people can test themselves regularly to monitor their infection status at will. ASSURE-100 Home Test kits contain only three simple components “ a swab, vial, and test cassette “ making them easy to use and affordable. The shallow nasal antigen test delivers a result in 20 minutes. Clinical trials for ASSURE-100 over-the-counter use demonstrated an excellent lower limit of detection, sensitivity of 84.7% (positive percent agreement) and specificity of 100% (negative percent agreement) in patients suspected of COVID-19 infection.