THE ASSURE-100 RAPID COVID-19 POC TEST
On February 28th, 2022, ASSURE-100 Rapid COVID-19 Tests were granted Emergency Use Authorization by the U.S. Food and Drug Administration.
The ASSURE-100 Rapid COVID-19 Test is indicated for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen from direct shallow nasal swab samples from individuals who are suspected of COVID-19 infection by the healthcare provider within the first eight (8) days of symptom onset.
Rapid, regular testing with guidance from healthcare professionals can help maintain the safe operation of schools, businesses, and large events or gatherings. Rapid antigen tests are less expensive and faster than traditional polymerase chain reaction (PCR) tests, providing accurate and reliable results within 20 minutes. ASSURE-100 Rapid COVID-19 Tests offer an easy and low-cost way to protect family members, classmates, and co-workers during, especially important for the holidays.
The ASSURE-100 Rapid COVID-19 Test EUA applicable settings include the following:
- H – Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M – Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W – Patient care settings operating under a CLIA Certificate of Waiver.
How Does the ASSURE-100 Rapid COVID-19 Test Work?
The ASSURE-100 Rapid COVID-19 Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. It provides accurate and reliable results within 20 minutes, allowing for widespread COVID-19 testing of symptomatic patients within the first eight days of symptoms. The ASSURE-100 Rapid COVID-19 Test is simple, fast, accurate and affordable, enabling a safe reopening for schools, businesses, and organizations around the world. ASSURE-100 was designed by scientists and engineers in Hawaii and is distributed worldwide.
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Info on U.S. FDA In Vitro Diagnostic EUAs
In vitro diagnostics (IVD) are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.
The ASSURE-100 Rapid COVID-19 Test is a SARS-CoV-2 IVD, used to quickly detect infection with the SARS-CoV-2 virus.
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there was a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves a novel coronavirus, now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the disease COVID-19.
On the basis of this determination, the Secretary of HHS subsequently declared that circumstances exist to justify the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19, pursuant to section 564 of the Act and subject to the terms of any authorization issued under that section.On February 28, 2022, ASSURE-100 Rapid COVID-19 Tests were granted Emergency Use Authorization by the U.S. Food and Drug Administration.
1. What is ASSURE-100?
The ASSURE-100 Rapid COVID-19 Test is a point-of-care rapid antigen test that uses an anterior nasal specimen to detect COVID-19, the disease caused by the SARS-CoV-2 virus. ASSURE is an acronym for: Accelerated Sensor Solution for Urgent Response to Epidemics.
2. Where was ASSURE-100 developed?
The ASSURE technology and ASSURE-100 rapid COVID-19 test was developed by Oceanit in Hawaiʻi and was put through testing and clinical trials in Hawaii and in other states across the US.
3. How do ASSURE-100 tests work?
ASSURE-100 uses shallow nasal specimens to detect COVID-19 using a lateral flow assay (LFA) test cassette. A shallow anterior nasal swab specimen is mixed with buffer solution and then poured into the well on the test cassette. ASSURE tests are visually read, and do not require an external device to interpret results.
4. Does ASSURE-100 detect the omicron, delta, and other variants?
Yes, clinical trial data showed that ASSURE-100 does detect the delta and omicron variants. Omicron clinical samples were confirmed via sequencing. Additionally, testing of the nucleocapsid proteins of the alpha, beta, and gamma variants demonstrated that ASSURE-100 detects these variants. Inactivated SARS-CoV-2 alpha and beta variants showed the same limit of detection as the original strain.
5. How quickly will ASSURE-100 detect a result if positive?
Results should be read at 20 minutes.
6. Where can I get ASSURE-100 tests?
ASSURE-100 POC test is sold directly to healthcare organizations and via authorized distributors. Under the current EUA, ASSURE-100 rapid COVID-19 POC test kits will be only sold for point of care use to organizations with a CLIA waiver.
For FDA Emergency Use Authorization (EUA) only. For more information click here.
The information on this page refers to the ASSURE-100 Rapid COVID-19 Test that has been authorized by the U.S. FDA under an emergency use authorization for use by CLIA and CLIA waived laboratories in Point of Care settings. The ASSURE-100 Rapid COVID-19 Test is for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner. The ASSURE-100 Rapid COVID-19 Test has not been FDA approved.