One Step Test for SARS-CoV-2 Antigen

(Colloidal Gold) (Saliva)

- For self-test

Intended Use

One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) is intended for the qualitative detection of SARS-CoV-2 antigens in human saliva samples. This test is used for individuals suspected of COVID-19 within the first seven days of the onset symptoms; such as headache, fever, cough, sore throat, loss of the sense of smell or taste shortness of breath, muscle pain. Meanwhile the test can also be applied for individuals without symptoms. Results are for the identification of SARS-CoV-2 antigen. 

This test is used for self-test.

About SARS-CoV-2

The novel coronaviruses belong to the β genus. SARS-CoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Use this test:

- If you want to test yourself.

- If you have symptoms similar to COVID-19, such as: e.g. headache, fever, cough, sore throat, loss of the sense of smell or taste, shortness of breath, muscle pain.

- If you are concerned about whether you are infected with COVID-19.

- Use of the test by persons under 18 years of age only under the supervision of an adult.

Contents

A kit contains:

Package specifications: 1 T/kit

1) SARS-CoV-2 antigen test card

2) Sample extraction solution

3) Disposable sampling swab

4) Disposable pipette

5) Biohazard sample bag

6) User manual: 1 piece/kit

Additional required material: clock/ timer/ stopwatch

Note: Do not mix or interchange different batches of kits.

Specifications

Operation

Test Results

1. Valid Test

Positive (+):

Two bands appear, one at the control area (C) and the other at the test line (T). The result indicates  the presence of SARS-CoV-2 antigen.

Negative (-):

A single band appears at the control area (C) and no other band at test line. The result indicates that the sample does not contain SARS-CoV-2 antigen or the concentration is below the limit of detection of the kit.

2. Invalid Test

If no band appears in the control area (C), the test result is invalid. The test should be repeated with a new test card and if the same situation reappears, please stop using this batch of products and contact your supplier.