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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 Beta-Cobs Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test
Composition : Detection card, sample buffer
Storage conditions : 2℃~30℃
term of validity : twelve months
Sample requirements : Serum, plasma or whole blood
This kit is for qualitative testing of 2019ncov neutralization
Antibodies for serum, plasma and whole blood samples
The new β cobs can cause viral pneumonia, and the main clinical symptoms are fever, fatigue, and dry cough. Some patients have stuffy nose, runny nose, sore throat, and diarrhea. Severely ill patients usually develop dyspnea and hypoxemia within a week and rapidly progress to acute respiratory distress syndrome, infectious shock, metabolic acidosis, and blood clot disorders.
The 2019 NCOV has several structural proteins such as nails, embedding and membranes.
(m) Nucleotide capsid (n). Of these, spinodon contains a receptor-binding domain (rbd) involved in the recognition of cell surface receptors for angiotensin converting enzyme 2 (ace 2). The 2019 NCoV spinoprotrusion RBD was found to be highly potent, interacting with human ACE 2 receptors, causing endoplasmic reticulum apoptosis and viral replication in lung host cells.
In 2019, NCOV infection or vaccination will provoke an immune response and produce antibodies in the blood. The secreted antibody prevents viral infection. They are present in the human circulatory system months to years after infection and rapidly and reliably bind to pathogens to prevent viral replication. These antibodies are called neutralizing antibodies. A neutralizing antibody test determines whether a person can resist a viral infection.
The kit includes a test card and a sample buffer.
Test card: Consists of aluminum foil bag, desiccant, test sheet and plastic card. The test piece consists of a water-absorbent paper, a nitrocellulose membrane, a test piece pad, an adhesive pad and a rubber piece. The cellulose nitrate membrane is coated with ACE 2 protein on the T line (detection line), AB protein on the C line (quality control line), and AB protein on the R line (control line). The binding pad label is 2019 NCOV AB.
Sample buffer: Phosphate, sodium azide, etc.
It is valid at 2 ° C to 30 ° C for 12 months.
The aluminum foil unwrapped bag is valid for 1 hour.
Details: See label.
Validity period: See Label.
1. Collect serum, plasma or whole blood samples.
2. Precipitates and suspensions in the reagents affect the experimental results and should be removed by centrifugation.
3. Anticoagulants: Heparin, EDTA, sodium citrate anticoagulants do not work.
4. Venipuncture is performed by a professional medical staff. We recommend that you give priority to serum and blood tests. In emergencies and special cases, a patient's entire blood sample can also be used for rapid testing.
5. Serum and plasma reagents should not be stored at room temperature for more than 8 hours. It is stored at 8 ° C for 5 days for these 2 days and then reaches 80 ° C for 6 months, but repeated freeze-thaw cycles should be avoided. Whole blood specimens cannot be frozen and should be stored at 2 ° C to 8 ° C for 48 hours or longer.
Please read the instructions carefully before the test. Test all reagents from room temperature to room temperature.
1. Remove the test card from the packaged reagent bag and use it within 1 hour.
2. Add L sample (serum, plasma, or whole blood) to the loading hole of the μ test card, and add 2 drops (about 60 drops μL) of sample buffer over time.
3. Observe the reaction for 10 to 15 minutes at room temperature. After 20 minutes, the result was invalid.
Test card description
1. Invalid result: The quality control line (C line) is invalid. There is no response line and it needs to be retested.
2. Negative result: The red band is displayed on the test line (T line), and the color development is displayed on the standard line (R line), quality control line (C line), and reference line (R line).
3. Positive result: A red band is displayed on the test line (T line), and the red band from the reference line (R line) and quality control line (C line) to the test line (T line) is color-coded and used as the standard. Color the line (R line).
This device is used only for in vitro diagnostics.
2. If there are too many or too small samples, the result will be false.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be affected as they can affect test results.
4. Reagent test results are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. The final diagnosis of this disease should be based on a comprehensive assessment of all clinical and laboratory results.
1. Specificity analysis
1.1 Cross-reaction: Due to the interference of reagents, the following types of antibodies were evaluated, and no cross-reactions occurred as a result.
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: In the new coronavirus (2019ncov) neutralizing antibody test item, the potential interference of the following substances is evaluated by adding the following substances to the sample of a specific concentration. Various interfering substances do not interfere with the detection results of the reagents.
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: The already commercially available 2019 ncov igg ab detection reagent (colloidal gold method) is used as a control reagent, and 120 positive reagents and 300 negative reagents are selected as detection reagents. The results can be 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 used only for in vitro diagnosis.
2. It cannot be used after it is disabled.
3. Before you start, read the operating instructions carefully and follow the reagent instructions.
4. In corrosive environment, acidic, sodium hypochlorite and other corrosive gases. After the experiment, the laboratory needs to be disinfected.
5. All samples and reagents used are potentially contagious and must be disposed of in accordance with local regulations.
6. Reagents must be used within the shelf life specified on the package. Remove the card from the aluminum foil bag to prevent moisture.
2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test Images |