SARS-CoV-2 Neutralizing Antibody Fast Test Kit

 (Immunofluorescence Assay)

Intended Use

SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative detection of SARS-CoV-2 neutralizing antibodies in human serum, plasma, venous whole blood or fingertip blood.

About SARS-CoV-2 Neutralizing Antibodies

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 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.

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.

Contents

1. For Getein1100/Getein1180

Package specifications: 1 test/box, 5 tests/box, 25 tests/box

1) Getein SARS-CoV-2 Neutralizing Antibody test card in a sealed pouch with desiccant

2) Sample diluent

3) Capillary pipet

4) User manual: 1 piece/box

5) SD card: 1 piece/box

2. For Getein1600

Package specifications: 2×24 tests/kit, 2×48 tests/kit

1) Sealed cartridge with 24/48 Getein SARS-CoV-2 Neutralizing Antibody test cards

2) User manual: 1 piece/box

Materials required for Getein1600:

1) Sample diluent: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

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

Specifications

Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1180 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

Operation

Clinical Application

1. The test is for in vitro diagnostic use only.

2. The test results of this kit are for clinical reference only. 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. This test is 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.