SHORT INTRODUCTION

The rapid antigen test is an in vitro diagnostic test that uses rapid immunochromatographic methods to qualitatively detect the novel coronavirus antigen in nasopharyngeal and oropharyngeal swabs. The identification is based on monoclonal antibodies against the novel coronavirus antigen. It will provide information for clinicians to prescribe correct medications.

This is an immunochromatographic membrane analysis method that uses monoclonal antibodies that are highly sensitive to the new coronavirus. The test device consists of the following three parts, namely sample pad, reagent pad and reaction membrane. The entire strap is fixed in a plastic device. The reagent membrane contains colloidal gold coupled with an anti-coronavirus monoclonal antibody; the reaction membrane contains a novel coronavirus secondary antibody and an anti-mouse globulin polyclonal antibody, which are pre-immobilized on the membrane. When the sample is added to the sample well, the dried conjugate in the reagent pad dissolves and migrates with the sample. If COVID 19 is present in the sample, the complex formed between the anti-COVID 19 conjugate and COVID 19 will be captured by the specific anti-New Corona monoclonal coated on the T area. Regardless of whether the sample contains this substance or not, the solution will continue to migrate and encounter another reagent (anti-mouse IgG antibody), which will bind to the remaining conjugate, resulting in a red line in the C area.

Features
A. High Sensitivity and Specificity
B. Available for professional and self test
C. PEI certification

D. Bfarm listed for both Self and professional Test

D. ANMAT Certified

Specimen collection and preparation

Wash your hands with soap.
Open the box and collect your own nasal cavity or saliva sample according to the manufacturer’s instructions included in the sample collection or test kit.
If you don’t collect samples as instructed, your test results may be incorrect.

Test procedure

Before testing, allow the test equipment, samples, buffers and/or controls to equilibrate to room temperature (15-30°C).
1. Bring the bag to room temperature before opening. Remove the test device from the sealed bag and use it as soon as possible.
2. Place the test equipment on a clean level surface. Turn the specimen collection tube upside down, squeeze 3 drops of the prepared specimen into the specimen hole (S) of the test box and start
Timer.
Please see the instructions below.

3. Wait for the colored line to appear. Read the results after 10 minutes. Do not interpret the results after 15 minutes.

INTERPRETATION OF RESULTS

-Positive (+) : Two colored lines appear.

One color line should always appear in the control line area (C) and another color line should appear in the T-line area.

* Note: The color intensity in the test line area may vary depending on the concentration of COVID-19 in the sample.

Therefore, any shade of color in the test line area should be treated as positive and recorded as positive.

Tell a healthcare provider about your positive test result and stay in contact with them during your illness. If your illness becomes severe, seek medical attention. To avoid spreading the virus to others.

-Negative (-) : A color line appears in the control line area (C).

There are no lines in the T-line region.

A negative test result means that SARS-CoV-2, the virus that causes COVID-19, was not found in your specimen. If you took the test while you had symptoms and followed all instructions carefully, a negative result means your current illness is probably not COVID-19.

However, it is possible for a test to give a negative result in some people who have COVID-19. This is called a false negative. You could also test negative if the specimen was collected too early in your infection. In this case, you could test positive later during your illness.

- Invalid: Control line does not appear.

Insufficient sample size or incorrect procedure technique are the most likely causes of control line failure.

Check the program and repeat the test with the new test.

If the problem persists, stop using the test suite immediately and contact your local dealer.

Company Profile

Hangzhou Immuno Biotech Co., Ltd. is a R&D based company located in Hangzhou. Immunobio is well known as a recombinant protein original designer and supplier in the upstream of in vitro diagnostic field. Immunobio is also a professional rapid test manufacturer who has advanced technology in veterinary diagnostic and human medical diagnostic industries. Immunobio has more than 30 authorized patents in IVD field and more than 20 under review.

To fight against the Vir, Immunobio has developed a series of rapid diagnostic test. In early February 2020, we released the IgG/IgM Antibody Rapid Test for the IgG and IgM antibodies testing. Then in September, Immunobio has successfully developed the Antigen Rapid Test to support the fast screening of antigen test. In December 2020, Neutralizing Antibody Rapid Test was developed in success, to indicate the protective status of the neutralizing antibodies in people’s blood.

Hangzhou Immuno Biotech Co., Ltd. is doing and will continue doing innovative research and development in the IVD medical diagnostic field. Immunobio will keep our promise to provide the innovative and competitive products for a healthy world.