Getein Biomedical - COVID-19 SARS-CoV-2 Total Antibody/ Neutralizing Antibody Rapid Test Kit (Immunofluorescence Assay)

Test Item: SARS-CoV-2 Total Antibody/ Neutralizing Antibody
Sample Type: Serum/ Plasma/ Whole Blood
Test Time: 15 min
Methodology: Immunofluorescence Assay

Intended Use

The SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay) is intended for in vitro qualitative detection of SARS-CoV-2 neutralizing antibody in serum, plasma or whole blood samples. The test is only used for professional and laboratory use, not for home testing.

About SARS-CoV-2

Specific antibodies will be produced within days to weeks as the immune system makes immune defense against the SARS-CoV-2 infection. Total antibody detection is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical symptoms and result of other diagnostic methods. The test result should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection. Total antibody may not be detected in the first few days of infection.

SARS-CoV-2 neutralizing antibody is a protective soluble protein secreted by adaptive immunizing cells after inoculation with SARS-CoV-2 vaccine or infection with SARS-CoV-2. These antibodies can specific bind with virus RNA 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.

Contents

1. For Getein1100

A box package contains 25 tests:

1. Getein SARS-CoV-2 Neutralizing Antibody test card in a sealed pouch with desiccant
2. Whole blood buffer: 1 bottle/box
3. Disposable pipette
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.

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

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.