Boson COVID-19 Antigen Home Test - 2 Test Cards

Description

The Rapid COVID Antigen Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 years or 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 with symptoms of COVID-19 within the first 6 days of symptom onset, or 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 swab samples from individuals aged 2 years or older when tested twice over three days with at least 24 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

• Rapid results: Compare to standard RT-PCR tests which could take multiple days for patients to receive their results, Boson Antigen testers 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;
• Requires just 1 test;
• 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 for “On-The-Go” testing.

Clinical Features 

The performance of the Rapid SARS-CoV-2 Antigen Test Card 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

• 2x Antigen Test Card 
• 2x Sterilized Swab 
• 2x Extraction Buffer Tube
• 1x 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