Fastep At Home COVID-19 Antigen Test - 2 Tests per Kit (FDA - EUA #220191)

 Description

Your insurance provider may cover the cost of up to 8 tests per month. Contact your provider for their reimbursement procedure.

If you are a Medi-Cal patient. please order your tests here.

The FASTEP COVID-19 ANTIGEN HOME TEST is a rapid lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.  This test is authorized for Emergency Use by the FDA for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 14 years and older with symptoms of COVID-19 within the first six days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.

This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.

Benefits/Features

• 2 tests per kit
  
• Rapid results: Compare to standard RT-PCR tests which could take multiple days for patients to receive their results, Fastep Antigen tests will show results within 15-20 minutes;
• Easy to use: Testing can be easily administered in almost any environment without additional special equipment. Easy to transport with no special storage requirements, a test kit is all you need;
• Patient comfort: Straight forward nasopharyngeal swab collection with clinically proven high accuracy results;
• Can be used to test children as young as 2 years old;
• For use with and without COVID-19 symptoms;
• No need to send off to a lab to obtain results;
• Compact packaging - Test on-the-go, anywhere, anytime.

Clinical Features 

The performance of the Fastep Antigen Test was established in a prospective clinical study of symptomatic individuals using an EUA molecular test as a comparator method. The data from this study were analyzed using the minimum recommended number of low positives demonstrating that the test correctly identified 82.7% of positive samples and correctly identified 99.1% of negative samples. 

Kit Components

• 2 x Antigen Test Card 
• 2 x Sterilized Swab 
• 2 x Extraction Buffer Tube
• Quick Reference Instructions

Test Procedure and Interpretation

WARNING: Do not read the result before 15 minutes or after 30 minutes. Inaccurate test interpretations may occur.

Emergency Use Authorization