One Step Test for SARS-CoV-2 Total Antibody/ Neutralizing Antibody

 (Colloidal Gold)

Intended Use

SARS-CoV-2 Neutralizing Antibody Rapid Test is intended for in vitro qualitative detection of SARS-CoV-2 neutralizing antibodies in human serum, plasma, venous whole blood or fingertip blood.

The SARS-CoV-2 neutralizing antibodies are protective antibody produced by the human body after inoculation with novel coronavirus vaccine or infection with novel coronavirus. The kit is used to monitor the presence of neutralizing antibodies in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus, it can be used to evaluate the immune effect after vaccination or whether neutralizing antibodies are produced in human body after infection with novel coronavirus, it should not be used to diagnose acute SARS-CoV-2 infection.

For professional use only.

About SARS-CoV-2 Neutralizing Antibody

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a worldwide pandemic with millions infected. The immune responses of human body to the severe COVID-19 have been well studied, and a number of antibody-based assays have been developed for serological studies. Moreover, the study of the neutralizing antibody that targets at a special structural protein of the SARS-CoV-2 is of interest.

Infection by the SARS-CoV-2 or immunized by vaccine against SARS-CoV-2 will induce immune responses, such as the production of antibodies in the blood. These antibodies can specifically bind with virus receptor binding domain (RBD) to block the binding of RBD with angiotensin-converting enzyme 2 (ACE2) on human cells surface, thus prevent the virus or its genetic material into the human cell and virus infection. These antibodies are named neutralizing antibodies.

Contents

A kit contains:

Package specifications: 25 tests/box

1) GeteinSARS-CoV-2 Neutralizing Antibodytest card in a sealed pouch with desiccant

2) Sample diluent

3) Capillary pipet

4) User manual: 1 piece/box

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

Specifications

Operation

Sample type:

1. Venous Blood

2. Fingertip Blood           

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 neutralizing antibodies.

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 neutralizing antibodies.

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.

Clinical Application

1. The test is for in vitro diagnostic use only. The test results of this kit are for clinical reference only.

2. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment response.

3. SARS-CoV-2 neutralizing antibody testing can be used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, it should not be used to diagnose acute SARS-CoV-2 infection.