This kit is intended to be used for the qualitative detection of SARS-CoV-2 antigen in human respiratory specimens, sputum and other samples. This kit uses cellulose membrane immunochromatography technology. Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection with SARS-CoV-2.

Test principle

The kit adopts cellulose membrane immunochromatography technology and applies the principle of membrane chromatography double antibody sandwich method to detect the SARS-CoV-2 antigens in human samples. The product consists of sample well and detection area on the Detection Strip.

The Detection strip contains coated anti-SARS-CoV-2 monoclonal antibody, colloidal gold particles labeled with anti-SARS-CoV-2 monoclonal antibody, and goat anti-mouse polyclonal antibody. When SARS-CoV-2 antigens are present in the sample, the SARS-CoV-2 antigens will combine with the colloidal gold-labeled anti-SARS-CoV-2 monoclonal antibody, it will be captured by the coated anti-SARS-CoV-2 monoclonal antibody. When the viral antigen crosses the T region of detection line, it will be captured by the coated anti-coronavirus monoclonal antibody, which will gather and develop color in the detection area.

Conversely, if SARS-CoV-2 antigens are not present in the sample or the antigen titer is below the limit of detection, there will be no color band appearance on the detection line and the result will be negative. Regardless of whether the sample contains antigens of the SARS-CoV-2, a color band should appear on the quality control region (C region)line of the detection area. The quality control band is the standard for judging whether the inspection process is normal and it also serves as the internal control standard for the Detection Strip.

COVID-19 RAPID ANTIGEN TEST

The COVID-19 rapid antigen test detects protein fragments specific to the

Coronavirus. Rapid antigen testing is a faster way to detect if you have a current

COVID-19 infection. Rapid antigen testing may be helpful for those who want

quick results to meet a testing requirement for an event or travel. For example,

this test can be used if you plan to visit a location or establishment that requires

testing prior to arrival. Testing requirements vary by location and may change

over time. This test requires a nasal or nasopharyngeal swab. With our product

testing, results may come back in as soon as 10 – 15 minutes.

Common COVID-19 symptoms include fever, cough, and shortness of breath.

How the test works?

A sample is collected through a nasal or throat swab and mixed with

a solution. The solution is then placed onto an indicator device that may

detect the presence of the virus that causes COVID-19.

Test Purpose: Used to detect an active infection.
Sample Type: Nasal or Nasopharyngeal Swab
Results Time: 10 – 15 Minutes*

(Wait times may vary depending on volume)

【When should I use a rapid antigen test?】

If you are a close contact, you can use an rapid antigen test for your initial and day

6 test. You can also purchase and use rapid antigen tests from us:

• before entering a high risk setting, e.g. healthcare or aged care
• before going out where there may be crowds
• before going to work, especially if it is a critical worksite
• to provide reassurance if you have no symptoms but are feeling anxious

or worried.

Accessing rapid antigen tests

If you are not a close contact, rapid antigen tests are sold commercially in

supermarkets and pharmacies.

Note: The components in the kits of different batch numbers are not interchangeable.

The materials and instruments necessary for the test but not provided are as follows:

Lancet;

Absorbent paper or similar material;

Timer;

Micropipette corresponding to the range;

Laboratory safety protection equipment such as disposable gloves, etc.

【RESULTS ANALYSIS】

The interpretation of visual interpretation results (as shown below):

1. The results can be read directly by naked eyes as shown in the figures below:

Positive result: a visible band

can be seen in both line C and line T.

2. Negative result: A visible band can be seen in line C only.

3. Invalid result: A visible band cannot be seen in line C, and the test must be

repeated using a new strip.

【MANAGEMENT OF RESULTS】

【REPORTING YOUR RESULT】

You are legally required to report all positive rapid antigen test results. You must

report your positive result if you get your test from a designated RAT Collection

Point, from a retail outlet, from your workplace or through any other means

(i.e. over the internet).

You can also report negative and invalid test results to help provide a full picture

of rates of COVID-19 testing in the state.

【WHAT DO I DO IF I HAVE A POSITIVE RESULT?】

【WHAT DO I DO IF I HAVE A NEGATIVE RESULT?】

If you are a close contact with no COVID-19 symptoms and test negative, you do not

need to get a PCR test to confirm your result.

If you have COVID-19 symptoms and test negative, you must get a PCR test to

confirm your result. Rapid antigen tests are not as sensitive as PCR tests, which

means that just because you have a negative result in a rapid antigen test, it does

not mean that you do not have COVID-19.

【STORAGE CONDITIONS AND SHELF LIFE】

Stored at 2°C ~ 30°C, and kept away from direct sunlight.

The validity period is 12 months.

After the aluminum foil bag is opened, the Detection Strip should be used within 1 hour.

The Sample Diluent Buffer should be capped immediately after usage.

Usage after the date of expiration is not recommended.

The date of manufacture & expiration is indicated on the label and package.

【FACTORY WORKSHOP】

【EXPORTER】

Magnus Internationa Limited

F12, New City Internationa Mansion A, 234 Huapao Ave.

Liuyang, Hunan Province 410300 China

Contact: Goodwellmedical@gmail.com

【AUTHORIZED REPRESENTATIVE】

Lotus NL B.V.

Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.

【PRODUCT AND STANDARDS】

【FAQ】