Brand Name : ZOSBIO
Model Number : 2019-NCoV Neutralizing Antibody
Certification : CE BfArm
Place of Origin : Henan
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
The kit is used for the qualitative detection of neutralizing antibodies to novel coronavirus (2019-nCoV) in human serum, plasma, and whole blood samples.
Novel coronavirus (2019-nCoV) is a novel coronavirus belonging to the coronavirus of the genus β. Can cause viral pneumonia, the clinical manifestations are mainly fever, fatigue, dry cough, a few patients with nasal congestion, runny nose, sore throat and diarrhea and other symptoms. In severe cases, dyspnea and / or hypoxemia occur a week later, with the rapid progress of acute respiratory distress syndrome, sepsis shock, difficult to correct metabolic acidosis and blood clotting dysfunction.
Novel coronavirus has several structural proteins, including S (s), envelope (E), membrane (M), and nuclear capsid (N). Among them, spinin contains a receptor binding domain (RBD) responsible for identifying cell surface receptor angiotensin convertase 2 (ACE2). It was found that the 2019-nCoV spike protein RBD interacts strongly with the human ACE2 receptor, in turn leading to endocytosis and viral replication of the host cells within the lung.
A 2019-nCoV infection or vaccination triggers an immune response that produces antibodies in the blood. Secresecreted antibodies prevent virus infection, which exist in human circulating systems for months to years and quickly bind firmly to pathogens to prevent replication of the virus, with antibodies called neutralizing antibodies. The detection of neutralizing antibodies can determine whether people have the ability to prevent virus infection.
The kit consists of a test card and a sample buffer.
Test card: composed of aluminum foil bag, desiccant, test paper and plastic card. The test paper is composed of water absorbing paper, cellulose nitrate film, sample pad, binding pad and plywood. The cellulose nitrate membrane T line (detection line) package has ACE2 protein, C line (QC line) package is mass control line antibody, and R line (control line) package has control antibody containing 2019-nCOV antigen on the binding pad.
Sample buffer: phosphate, sodium nitride, etc.
2 ℃ ~30 ℃ Save, valid for 12 months.
Effective for 1h. after removing the aluminum foil bag
Product lot number: see the label for details.
Product failure date: see the label for details.
1. collected serum, plasma, or whole blood samples.
The sediment and suspended objects in the 2. samples may affect the experimental results and should be centrifuged.
3. Anticoagulant: No significant effect on using heparin, EDTA, and sodium citrate anticoagulant.
4. blood collection should be carried out by professional medical staff with preferred serum / plasma testing and whole blood samples available for rapid testing in emergency or special situations.
5. serum and plasma samples can be stored at room temperature beyond 8h,2 ℃ ~8 ℃ for 5 days, and under-20 ℃ for 6 months but to avoid repeated freezing and thawing. Whole blood samples shall not be frozen and shall not exceed 48 h. under 2 ℃ ~8 ℃
1.Invalid result: quality control line (C line) no reaction line, invalid detection, should be retested.
2. negative results: red band appears in test line (line T), and color show above or equal to control line (R line), mass control line (line C line) and control line (line R) show color.
3. positive results: no red band in test line (T line) or red band in test line (T line), but the color display was lower than control line (R line), mass control line (C line) and control line (R line).
1.This kit is qualitative detection and is only used for in vitro assisted diagnosis.
2. Make sure a proper sample is added for testing. Too much or too small a sample size can cause inaccurate results.
3. hemolysis, hyperlipidemia, jaundice and contaminated samples may affect the test results and these samples should be avoided.
4. The test results of this reagent are only for clinical reference only and shall not be used as the sole basis for clinical diagnosis and treatment. The final disease diagnosis should be made after comprehensive evaluation of all clinical and laboratory results.
1. This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
2. Make sure you add the right amount of samples for testing. Too many or too few samples may result in inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect test results and should be avoided.
4. The test results of this reagent are only for clinical reference and should not be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after a comprehensive evaluation of all clinical and laboratory results.
1. Analysis of specificity
1.1 Cross-reaction: The following types of antibodies were assessed with reagents and the results showed 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 Interference substances: The following concentrations were added in the specified concentration sample to assess their potential interference in the novel coronavirus (2019-nCoV) and in the antibody test program. The results showed that the various interfering substances do not disturb the test results of the 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. 2. clinical study: Listed Novel Coronavirus (2019-nCoV) IgG antibody detection reagent (colloidal gold method) was used as the comparative reagent, and 120 positive samples and 300 negative samples were selected respectively. The results were 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 used for in vitro diagnosis only.
2. This product is a disposable product, non-recyclable.
3. carefully before operation and conduct experimental operation in strict accordance with the reagent instructions.
4. avoids experiments in harsh conditions (such as high concentration of corrosive gases and dust containing 84 disinfectant, sodium hypochlorite, acid-alkali or acetaldehyde), and laboratory disinfection shall be conducted after the end of the experiment.
All samples of 5. and used reagents shall be considered potentially infectious and discarded in accordance with local regulations.
The 6. reagent should be used within the validity period of the outer packaging label. The test card should be used as soon as possible after being removed from the aluminum foil bag to prevent moisture exposure.
|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
CE Coronavirus Neutralizing Antibody Rapid Test Detection Card Sample Buffer Images