Fastep® COVID-19 Antigen Pen Home Test

For general information on COVID-19, including the symptoms of COVID-19, infection control precautions, and other information please check the CDC COVID-19 webpage (see links provided in “Where can I go for updates and more information?” section at the end of this document) or your local jurisdiction’s website for the most up to date information.

• The Fastep® COVID-19 Antigen Pen Home Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two (2) years or older.
• The Fastep® COVID-19 Antigen Pen Home Test is authorized for individuals with symptoms of COVID-19 within the first six (6) days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
• There is a higher chance of false negative results with antigen tests than with laboratorybased molecular tests due to the lower sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 as compared to a molecular test, especially in samples with low viral load.

A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and therefore the individual being tested is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in determining individual diagnosis and patient management decisions and should follow current CDC guidelines.

The Fastep® COVID-19 Antigen Pen Home Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks could include the following: a needless recommendation for the patient to isolate that might limit contact with family or friends and the ability to work, delayed diagnosis and treatment for the true infection causing the patient’s symptoms, potentially increased likelihood that the patient could contract COVID-19 2 | P a g e from other potentially COVID-19 positive patients isolated in the same areas, unnecessary prescription of a treatment or therapy, needless monitoring of close contacts for symptoms, or other unintended adverse effects.

All healthcare providers must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

A negative serial test result for this test means that SARS-CoV-2 antigens was not present in the specimen above the limit of detection. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions (such as discontinuation of isolation precautions). Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids.

The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day six (6) of illness may be more likely to be negative compared to a RT-PCR assay. Therefore, negative results from patients with symptom onset beyond six (6) days should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of an individual’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the individual’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing or testing with molecular methods should be considered by healthcare providers in consultation with public health authorities.

Risks to a patient of a false negative test result include delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of COVID-19 spread within the community, or other unintended adverse events.

For additional recommendations regarding infection control, refer to CDC’s Ending Isolation and Precautions for People with COVID-19: Interim Guidance (see links provided in “Where can I go for updates and more information?” section).

The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between August 2022, and January 2023. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

Serial testing of individuals whose initial test result is negative assists in identifying infected individuals earlier and facilitate timely infection control practices. A negative test result does not rule out infection but repeat testing over three days for symptomatic individuals or five days for asymptomatic individuals with at least 48 hours between tests may decrease the risks of false negative results.

An initial negative test result should be the first of a minimum of two tests. An asymptomatic individual undergoing serial testing who obtained two or more negative test results may require ongoing serial testing or confirmatory testing, depending on patient history and potential exposures. An asymptomatic individual undergoing serial testing who obtained one or more positive results indicates that SARS-CoV-2 antigen is present in the patient’s sample but does not rule out coinfection with other pathogens.

For additional recommendations regarding confirmation of antigen test results, please refer to the CDC’s Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community (see links provided in “Where can I go for updates and more information” section).

The U.S. FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

An IVD made available under an EUA has not undergone the same type of review as an FDAapproved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless the declaration is terminated or authorization is revoked sooner

Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases here: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/medical-device-databases. A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization.

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088

CDC WEBPAGES:

General: https://www.cdc.gov/coronavirus/2019-ncov/index.html

Symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html

Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html

Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html

Isolation Precautions in Healthcare Settings: https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

Infection Control: https://www.cdc.gov/coronavirus/2019-ncov/php/infection-control.html

Discontinuation of Isolation: https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html

Antigen Testing: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html

FDA WEBPAGES:

General: www.fda.gov/novelcoronavirus

EUAs: (includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas

Serial Testing: https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-stepsreduce-your-risk-false-negative-results-fda-safety

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