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2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test

Henan Lantian Medical Supplies Co.,Ltd.

2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test

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

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2019 Beta-Cobs Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test

Intended Use


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.

Principle of Detection


This kit uses imno chromatography. The test card contains quality control line C, test line T and reference line R. The test reagents (serum / plasma / whole blood) diffuse upward into the loading trap by capillary action, and the binding pad maker s-rbd binds to the hardened aceo 2 protein on the nc membrane and signals at the t-line position. Can be detected. If a neutralizing antibody is present in the sample, it binds to the s-rbd antigen on the label as it passes through the label. Neutralizing antibodies block the binding of s-rbd to ACE 2 and reduce signal values. The T-ray signal value has a negative correlation with the content of neutralizing antibody. If the antibody concentration is high enough in the middle, there is no color in the T line. Whether or not the T line has a color, the reference line R and the quality control line C have a color. Quality control C line
If there is no color on the C line, the test is invalid and the sample must be tested again.

Main Components


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.

Storage Conditions and Validity


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.

Sample Requirements


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.

Test Method


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.

Interpretation of Test Results


2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test

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).

Limitation of Test Method


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.

Product Performance Indicators


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

2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test

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%)

Precautions


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.

Company profile


2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test
Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise engaged in the research and development, production and operation of in vitro diagnostic products. The in vitro diagnostic products developed by the company cover POCT series, microbial series, biochemical series and immune series reagents and supporting instruments.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.


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