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SARS-CoV-2 Neutralizing Antibody Test

Vaperon™ SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit is intended for the identification of individual's adaptive immune response to SARS-CoV-2.

SARS-COV-2 Neutralizing antibody Detection Kit

Intended Use

Vaperon™ SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold) is an immunochromatographic assay, used to visually detect the total neutralizing antibodies in human serum, plasma or whole blood specimen with high sensitivity and specificity.

Vaperon™ SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit is intended for identifying individuals with adaptive immune response to SARS-CoV-2, indicating recent or prior infection or vaccination. The SARS-COV-2 Neutralizing antibody test kit should NOT be used to diagnose acute SARS-CoV-2 infection.

Why Neutralizing Antibodies Matter

Neutralizing antibodies are the subpopulation of the antibodies secreted by the immune cells after the invasion of the COVID-19 or injection of vaccine, which are specific to the receptor-binding domain (RBD) of the SARS-COV-2 virus, and can block the cellular infiltration and viral replication. In this sense, the neutralizing antibodies, either incurred by virus or vaccination, is the first ladder of "soldiers" in human body, which fight against the COVID-19 virus.

Vaperon™ SARS-COV-2 Neutralizing antibody kit

Vaperon™ is a new trade name, which Atlas Link Technology Co., Ltd specially adopted for the new SARS-COV-2 Neutralizing antibody detection kit; brand name application in process.

SARS-CoV-2

Novel coronavirus pneumonia (Coronavirus Disease 2019, short as COVID-19) is an infectious disease caused by SARS-COV-2 infection. On February 11, 2020, the International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2.

SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M) and nucleocapsid (N). The spike protein (S) contains a receptor-binding domain (RBD), which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ACE2). It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor, leading to endocytosis into the host cells of the deep lung and viral replication.

COVID-19 Neutralizing Antibody Test: Specimen Collection, Packing, Principle...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
COVNA 503 SARS-COV-2 Neutralizing Antibody Test serum/WB/plasma 20 Bulk: 1200 PCS
Boxed: 55 Boxes
How to Use

SARS-COV-2 Neutralizing Antibody Test

General Information

(IVD Kit »-» Respiratory Tract Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:COVNA 503
Description:SARS-COV-2 Neutralizing Antibody Test
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:100%
Specificity:100%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:20 Tests
Box Dimension:15.5 * 12.5 * 6.5 CM
Kits per CTN:55 Kits
Carton Dimension:53 * 44 * 35 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.082 CBM
GW per CTN (Boxed):13.3 KG
GW per CTN (Bulk):14.5 KG

Materials Provided in the Test Kit

  • Test Cassettes (20×)
  • Assay Diluent [5ml/bottle] (1×)
  • Alcohol Prep Pad (20×)
  • Sterile Disposable Self-spring Lancet (20×)
  • Blood Transfer Pipette (20×)
  • Instruction for Use (1×)

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Whole Blood Collection

For COVID-19 IgG/IgM rapid test and SARS-COV-2 Neutralizing antibody test, finger tip whole blood can be collected on the point of care with the lancets included in the test kits.

Clean the area to be lanced with an alcohol swab.

Squeeze the end of the fingertip and pierce with the self-spring lancet.

Collect the blood with the mircro pipetter to the mark for about 10 µl of blood; and add the blood into the sample well of the test cassette.

If not tested in the field, whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

serum/WB/plasma Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage.

Don’t freeze and thaw the specimens repeatedly.

Prior to testing, bring frozen specimens to room temperature slowly and naturally, and shake the specimen to mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle