Frequently Asked Questions

These FAQs are intended to answer questions about the ASSURE-100 rapid COVID-19 point-of-care test kit.

What does ASSURE stand for?

ASSURE is an acronym, standing for: Accelerated Sensor Solution for Urgent Response to Epidemics.

Where was ASSURE developed?

The ASSURE technology was developed in Hawaiʻi and put through testing and clinical trials in the USA

What is ASSURE-100?

ASSURE-100 is a point-of-care (POC) rapid antigen test that uses an anterior nasal specimen to detect COVID-19, the disease caused by the SARS-CoV-2 virus.

How do ASSURE-100 tests work?

ASSURE tests use swabbed specimens to detect COVID-19 using a test cassette, similar to a home pregnancy test. ASSURE-100 uses a shallow nasal swab specimen that is mixed with buffer solution. This mixture is then dropped on the test cassette. ASSURE tests are visually read, and do not require a device or lab to interpret results.

Who should use this test?

The ASSURE-100 rapid test is for patients who are suspected of exposure to COVID-19 and should be administered by a healthcare provider within the first 7 days of symptom onset, or within 2-9 days of exposure.

Does ASSURE-100 detect the new delta variant? Other variants?

Yes, inactivated SARS-CoV-2 alpha and beta variants showed the same limit of detection with ASSURE as the original strain. Additionally, testing of the nucleocapsid proteins on the alpha, beta, gamma, and delta variants demonstrated that ASSURE-100 detects these variants.

Further testing will be conducted as additional clinical samples and inactivated virus variant strains become available.

Does ASSURE-100 inadvertently detect other coronaviruses (like SARS-CoV or MERS-CoV) as positive?

No, unlike other rapid antigen tests, the ASSURE-100 Rapid COVID-19 Test has demonstrated that it is highly specific and does not falsely detect other coronaviruses as positive.  It has been wet-tested with Human coronavirus 229E, oc43, nl63, SARS-CoV, and MERS-CoV.

ASSURE had no cross-reactivity when tested with a panel of coronaviruses, high prevalence disease agents, and normal or pathogenic flora. ASSURE had no interference when tested with a panel of coronaviruses, high-prevalence disease agents, normal or pathogenic flora, household substances, and nasal medications.

How quickly will ASSURE-100 detect a result if positive?

A positive result can be read on ASSURE-100 in as little as 5 minutes. A negative result should not be read before 20 minutes. Results should not be read after 30 minutes.

How do I know if the result is positive or negative?

To check for a positive result, examine the window in the ASSURE-100 test cassette. First confirm if a reddish control line is present. If a control line AND a second reddish line, even a faint one, appear in the cassette window, your test returned a positive result. A negative result will have only one reddish line, where the cassette reads “control.”

How do I know if my test result is invalid?

If your test cassette window has no visible line by the “control,” then your test is invalid. Please repeat the test with a new ASSURE-100 test kit.

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