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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
This kit is used for the qualitative detection of novel coronavirus (2019-nCoV) neutralizing antibodies in human serum, plasma and whole blood samples.
Novel coronavirus (2019-NCoV) is a novel coronavirus belonging to the genus β. Can cause viral pneumonia, clinical manifestations with 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 usually develop after a week, and in severe cases, rapid progression to acute respiratory distress syndrome, septic shock, refractory metabolic acidosis, and haemorrhagic dysfunction.
Novel coronavirus has several structural proteins, including spikes (S), envelopments (E), membranes (M), and nucleocapsids (N). The spikes contain a receptor binding domain (RBD) that recognizes the cell surface receptor angiotensin-converting enzyme 2 (ACE2). We found that RBD of the 2019-nCoV spike protein strongly interacts with the human ACE2 receptor, leading to endocytosis of host cells and viral replication in the lung.
2019-nCoV infection or vaccination triggers an immune response that produces antibodies in the blood. They remain in the body's circulatory system for months to years after infection and bind quickly and firmly to the pathogen, preventing the virus from replicating. These antibodies are called neutralizing antibodies. A neutralizing antibody test can determine whether a person has this ability to prevent infection.
The kit consists of a test card and a 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 plate. Nitrocellulose membrane T line (test line) was coated with ACE2 protein, C line (quality control line) was coated with quality control line antibody, R line (control line) was coated with control antibody, and the binding pad contained marker labeled 2019-nCoV antigen.
Sample buffer: phosphate, sodium azide, etc.
Store at 2℃ ~ 30℃ for 12 months.
The validity period of the aluminum foil bag is 1h after unpacking.
Batch No. : See label for details.
Expiration date: see label for details.
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample may affect the experimental results, and should be removed by centrifugation.
3. Anticoagulants: the use of heparin, EDTA and sodium citrate anticoagulants had no significant effect.
4. Blood collection should be performed by medical professionals. Serum/plasma testing is recommended as a priority. In emergency or special circumstances, a patient's whole blood sample can also be used for rapid testing.
5. Serum and plasma samples should not be stored at room temperature for more than 8h. They can be stored at 2℃ to 8℃ for 5 days and below -20℃ for 6 months, but repeated freeze-thaw cycles should be avoided. The whole blood sample shall not be frozen and stored at 2℃ ~ 8℃ for no more than 48h.
Read the instructions carefully before the test. Restore all reagents to room temperature before testing. The test should be conducted at room temperature.
1. Take the test card out of the packaged reagent bag and use it within 1 hour.
2. Add 20μl sample (serum, plasma or whole blood) to the filling well of the test card, then add 2 drops (about 60μl) sample buffer, and start timing.
3. Reaction at room temperature for 10 ~ 15 minutes to read the results. The result was invalid after 20 minutes.
Judgment diagram of test card results:
1. Invalid results: no reaction line appeared on the quality control line (line C), and the test was invalid, so the experiment should be redone.
2. Negative results: red bands appear on the test line (Line T), and the color rendering is higher than or equal to the control line (Line R), quality control line (Line C) and control line (Line R).
3. Positive result: no red band appeared on the test line (Line T) or red band appeared on the test line (Line T), but the color rendering was lower than that of the control line (Line R), and the quality control line (Line C) and the control line (Line R).
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 evaluated for interference 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 |
8 | Adenovirus | No | 17 | Varicella-zoster virus | No |
9 | Rhinovirus | No | 18 | Mycoplasma pneumoniae | No |
1.2 Interfering Substances: The potential interference of the following substances in the Novel Coronavirus (2019-nCoV) neutralizing antibody test program was evaluated by adding the following substances to a specified concentration sample. The results showed that all kinds of interfering substances did not interfere with the detection results of this reagent.
Interfering substances | Concentration | Interfering substances | Concentration |
Bilirubin | ≤50mg/dL | Triglycerides | ≤15mmol/mL |
Hemoglobin | ≤5g/L | Cholesterol L | ≤500mg/d |
Rheumatoid factor | ≤500IU/mL | Human total IgG | ≤14mg/mL |
Ribavirin | 0.4mg/mL | Fluticasone | 0.5mg/mL |
Oxymetazoline | 10mg/mL | Dexamethasone | 5 mg/mL |
Histamine hydrochloride | 10mg/mL | Triamcinolone acetonide | 5mg /mL |
Tobramycin | 1mg/mL | Levofloxacin | 0.2 mg/mL |
Oseltamivir | 1mg/mL | Azithromycin | 0.1 mg/mL |
Zanamivir | 1mg/mL | Ceftriaxone | 0.4 mg/mL |
Arbidol | 0.5mg/mL | Meropenem | 0.2 mg/mL |
2. Clinical study: 120 positive samples and 300 negative samples were selected by using the marketed Novel Coronavirus (2019-nCoV) IgG detection reagent (colloidal gold method) as the contrast reagent, and the results were summarized as follows:
2019-nCoV IgG Ab detection reagent (colloidal goldmethod) |
Sum | |||
Positive | Negative | |||
Positive | 115 | 5 | 120 | |
Negtive | 5 | 295 | 300 | |
Sum | 120 | 300 | 420 | |
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, which can not be recycled and reused after use.
3. Read the operation instructions carefully before operation, and carry out the experiment in strict accordance with the reagent instructions.
4. Avoid conducting the experiment in harsh environment (such as environment containing high concentration of corrosive gas and dust such as 84 disinfectant, sodium hypochlorite, acid and alkali or acetaldehyde). Laboratory disinfection should be carried out after the end of the experiment.
5. All samples and used reagents should be regarded as potentially infectious substances and disposed of in accordance with local regulations.
6. Reagents should be used within the validity period marked on the outer package. The detection card should be used as soon as possible after it is taken out of the aluminum foil bag to prevent moisture.
Do not re-use |
| Store at 2℃~30℃ | |
Consult instructions for use | In vitro diagnostic medical device | ||
Batch code | Use-by date | ||
Keep dry | Keep away from sunlight | ||
Authorized representative in the European Community | Manufacturer |
ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD
Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA
Tel:+86-371-55016575
Email:zosbio@zosbio.com
Web:www.zosbio.com
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
SARS-CoV-2 Coronavirus Neutralizing Antibody Rapid Test Images |