COVID-19(SARS-CoV-2) Antigen Home Test with EUA Certification

In the USA, this product has not been FDA cleared or approved ; but has been authorized by FDA under an Emergency Use Authorization.

EUA Number : EUA220400

A.Intended Use

The Bio-Self™COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.

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 adult-collected anterior nasal(nares) swab samples from individuals aged 2 years or older.This test is authorized for individuals with symptoms of COVID-19 within the first 7 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.

B. Advantage&Features

1. Sensitivity :96.2% 

2. The pathogen can be detected at the initial stage of infection

3. Short TAT and simple operation.

4. No professional technicians and equipment are required, and the test can be completed in 15 min.

5. Home use.

6. Personal test.

7.Safe for individuals aged 2 years or older

C. Specification

1 Test/Kit;

2 Tests/Kit;

5 Tests/Kit;

20 Tests/Kit

D. Operation Process

Unpack components ,and place on a flat,clean surface.

E.Result Read

F. Product Qualification（by Sept.13th,2023）