Rapid SARS-CoV-2 Antigen Test Card (Health Canada Authorization)

1. Product Introduction

The Rapid SARS-CoV-2 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 (nares) swab samples from individuals aged 14 years or older, or with adult-collected anterior nasal (nares) swab samples from individuals aged 2 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 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.

2.   FAQ

Q: WHAT IS SERIAL TESTING?  

A: Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. Serial testing (i.e. testing every day or every other day) is more likely to detect COVID-19. Testing should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.  

Q: WHAT IF YOU TEST POSITIVE?

A: A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result. Your healthcare provider will work with you to determine how best to care for you based on your test result, medical history, and symptoms.

Q: IS THERE OTHER INFORMATION AVAILABLE DESCRIBING THE PERFORMANCE OF THIS TEST?

A: Yes. Please see the Healthcare Provider Instructions for Use available at www.bosonbio.com for additional information. The performance of this test is still being studied in patients without signs and symptoms of respiratory infection and for serial screening. Performance may differ in these populations.

3.   Company Introduction

Xiamen Boson Biotech Co., Ltd., as a specialist of in vitro diagnostic kits field was founded in 2001, develops and manufactures high-quality point of care and other immunoassay test kits for the world-wide market. Our factory is operated strictly under ISO 13485 and GMP guidelines. Our product lines provide immunoassays in various formats to detect infectious diseases, cardiac markers, drugs of abuse, fertility hormones and tumor markers. Many of our products have been approved by the China NMPA and are CE certified.

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