Brand Name : ZOSBIO
Model Number : 2019-NCoV Neutralizing Antibody
Certification : CE BfArm
Place of Origin : Henan,China
MOQ : To be negotiated
Price : To be negotiated
Supply Ability : 10000 Kit/Kit per Day
Delivery Time : To be negotiated
Packaging Details : Kit
Product name : 2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography)
Composition : Detection card, sample buffer
Storage conditions : 2℃～30℃
term of validity : 12 months
Sample requirements : Serum, plasma or whole blood
This kit is used for the qualitative detection of new coronavirus neutralizing antibodies in human serum, plasma and whole blood samples.
The 2019-new coronavirus is a new type of coronavirus, which belongs to β-coronavirus. It can cause viral pneumonia, and the main clinical manifestations are fever, fatigue, and dry cough. A small number of patients will also have symptoms such as nasal congestion, runny nose, sore throat and diarrhea. Critical cases often develop dyspnea and/or hypoxemia after a week, and critical cases rapidly develop into acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, and coagulopathy.
The new coronavirus has a variety of structural proteins, such as envelope protein (S), envelope protein (E) and membrane protein
Among them, the spike protein contains a receptor binding domain (RBD), which is responsible for recognizing angiotensin converting enzyme 2 (ACE2) on cell surface receptors. The study found that the 2019-n coronavirus spike protein RBD strongly interacts with human ACE2 receptors, which in turn leads to host cell endocytosis and virus replication in the lung.
New coronavirus infection or vaccination will trigger an immune response and produce antibodies in the blood. The secreted antibodies can prevent viral infections. After infection, they stay in the body's circulatory system for months to years, and quickly and firmly bind to the pathogen to prevent virus replication. These antibodies are called neutralizing antibodies. A neutralizing antibody test can determine whether a person can prevent viral infections.
This kit uses immunochromatography. The test card contains quality control line C, test line T and reference line r. Test samples (serum/plasma and whole blood) capillary action load, binding and S-RBD manufacturer pad binding to fix ACE2 in the NC membrane protein, which can detect and signal the position line. If there is a neutralizing antibody in the sample, then when it flows through the labeled pad, it will bind to the labeled S-RBD antigen. The neutralizing antibody can prevent the binding of S-RBD to ACE2, resulting in a decrease in signal value. The t-line signal value is negatively correlated with the content of neutralizing antibody. When the concentration of neutralizing antibody is high enough, the t-ray is colorless. Regardless of whether the t line is colored or not, the reference line R and the quality control line C are colored. Adopt quality control line C line
Quality Control. If there is no color display on the C line, the test is invalid and the sample must be tested again.
The kit consists of a test card and sample buffer.
Test card: It is composed of aluminum foil bag, desiccant, test strip, and plastic card. The test strip is composed of absorbent paper, nitrocellulose membrane, sample pad, binding pad, and rubber sheet. The nitrocellulose membrane T line (detection line) covers the ACE2 protein, the C line (quality control line) covers the quality control line, the R line (reference line) covers the reference Ab, and the binding pad contains the label 2019-nCoVAb.
Sample buffer: phosphate, sodium azide, etc.
The storage temperature is 2°C~30°C, and the validity period is 12 months.
The validity period of the aluminum foil bag is 1 hour.
Production batch. : See the label for details.
Deadline: See the label for details.
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended solids in the sample may affect the experimental results and should be removed by centrifugation.
3. Anticoagulant: heparin anticoagulant, EDTA anticoagulant and sodium citrate anticoagulant have no obvious effect.
4. The blood collection work should be carried out by medical professionals. It is recommended to give priority to serum/plasma testing. In emergency or special circumstances, a patient's whole blood sample can also be used for rapid testing.
5. Serum and plasma samples are stored at room temperature for more than 8 hours. He/she/them
It can be stored for 5 days at 2-8°C, and for 6 months at below 20°C, but repeated freezing and thawing should be avoided. Whole blood samples should not be frozen and should be stored at 2°C~8°C for no more than 48 hours.
Test card explanation:
1. Invalid result: the non-response line on the quality control line (line C) is invalid and should be tested again.
2. Negative results: the test line (T line) is displayed as a red strip, the color is higher than or equal to the reference line (R line), and the quality control line (C line) and the reference line (R line) are colored.
3. Positive result: there is no red band on the test line (T line), the color of the red band on the test line (T line) is smaller than the reference line (R line), and the quality control line (C line) and the reference line (R line) are colored.
1. This kit is used for qualitative testing and is only used for in vitro auxiliary diagnosis.
2. Make sure to add the appropriate number of samples for testing. Too much or too little sample size will lead to inaccurate results.
3. Hemolysis, lipids, jaundice and contaminated samples may affect the test results and should be avoided.
4. The test results of this reagent are for clinical reference only, and should not be used as the only basis for clinical diagnosis and treatment. After a thorough evaluation of all clinical and laboratory results, a final diagnosis should be made.
1. Analysis of specificity
1.1 1.1 Cross-reaction: The following types of antibody interference reagents were evaluated, and the results showed that there was no cross-reaction.
|SN||Item||Cross reaction||SN||Item||Cross reaction|
|1||Endemic human coronavirus OC43||No||10||Enterovirus||No|
|2||Endemic human coronavirus HKUI||No||11||EB virus||No|
|3||Endemic human coronavirus NL63||No||12||Measles virus||No|
|4||Endemic human coronavirus 229E||No||13||Human cytomegalovirus||No|
|5||Influenza A virus||No||14||Rotavirus||No|
|6||Influenza B virus||No||15||Norovirus||No|
|7||Respiratory syncytial virus||No||16||Mumps virus||No|
1.2 Interfering substances: Add the following substances to the samples at specific concentrations to evaluate their potential interference in 2019-nCoV and Ab test projects. The results showed that all kinds of interfering substances did not interfere with the test results of this reagent.
|Interfering substances||Concentration||Interfering substances||Concentration|
|Rheumatoid factor||≤500IU/mL||Human total IgG||≤14mg/mL|
|Histamine hydrochloride||10mg/mL||Triamcinolone acetonide||5mg /mL|
2. Clinical research: 120 positive samples and 300 negative samples were selected for detection with the listed 2019-nCoVIgGAb detection reagent (colloidal gold method) as the comparative reagent. The research results are summarized as follows:
2019-nCoV IgG Ab detection reagent (colloidal goldmethod)
|Sensitivity||95.83%, (95%CI: 90.62%～98.21%)|
|Specificity||98.33%, (95%CI: 96.16%～99.29%)|
1. This product is only used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Read the operating instructions carefully before operation, and perform experimental operations in strict accordance with the reagent instructions.
4. Avoid testing under harsh environmental conditions (including 84 kinds of disinfectants, sodium hypochlorite, acids, alkalis, acetaldehyde and other high-concentration corrosive gases, dust, etc.). After the experiment, laboratory disinfection should be carried out.
5. All samples and reagents used should be considered as potentially infectious materials and handled in accordance with local regulations.
6. The reagent should be used within the validity period indicated on the outer packaging. The test card should be used as soon as possible after being taken out of the foil bag to prevent moisture.
|Do not re-use|| |
|Store at 2℃～30℃|
|Consult instructions for use|| |
In vitro diagnostic medical
|Batch code|| |
|Keep dry|| |
|Keep away from sunlight|
Authorized representative in the
ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD
Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
COVID-19 Neutralizing Antibody Rapid Test Kit Immunochromatography Images