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2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus

Henan Lantian Medical Supplies Co.,Ltd.

2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus

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 Coronavirus Neutralizing Antibody Rapid Test Virus

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-NCoV Coronavirus Neutralizing Antibody Rapid Test Virus

Intended Use


This biosensor will be used to detect neutralizing antibodies to the new coronavirus (2019 ncov) in human serum, plasma and whole blood samples.
2019 Coronavirus disease Corona Beer 2019 (NCOV) β, Geiryu Net is a new coronavirus. It causes viral pneumonia. Clinical symptoms include fever, dullness, and dry cough, and some patients have symptoms such as stuffy nose, runny nose, sore throat, and diarrhea. Severe dyspnea and / or hypoxemia usually occur within a week. In severe cases, it progresses rapidly due to acute dyspnea syndrome, infectious shock, metabolic acidosis, and impaired bleeding function.
The novel coronavirus has many structural proteins such as s, E, m, and n. The mitotic spindle contains a receptor binding domain (RBD) that identifies the cell surface. Receptor angiotensin converting enzyme 2 (ACE 2). The 2019 ncov tattoo protein RBD was found to have a strong interaction with the human ACE2 receptor and induce viral replication in host cells and lungs.
novel coronavirus infections and vaccinations provoke an immune response and produce antibodies in the blood. Once infected, it stays in the circulatory system for months to years. It binds quickly and closely to pathogens to prevent viral replication. This antibody is called a neutralizing antibody. Neutralizing antibody tests can determine if people can prevent infections.

Principle of Detection


This element is immunochromatography The test card includes quality control line C, detection line T and control line R. The sample (serum / plasma / whole blood) is capillarized after the sample is completed. The s-rbd binds to the ACE2 protein immobilized on the NC membrane, including the marker on the binding pad, and can detect the signal at the position of the T line. If neutralizing antibodies are present in the sample, the s-rbd antigen on the label is bound to the marker pad. Neutralizing antibodies interfere with the binding of s-rbd to ACE2 and reduce signal values. The T-ray signal value has a negative correlation with the content of neutralizing antibody. If the neutralizing antibody concentration is high enough, the t-line loses its color. The control line R and the horizontal control line C should be colored regardless of the color of the T line. Quality control line C is used for quality control. If the c-line does not have a color display, the test is invalid and the sample must be retested.

Main Components


The kit consists of a test card and sample buffer.
Test card: Consists of aluminum foil bag, desiccant, test sheet and plastic card. It consists of an absorbent, a nitrocellulose membrane, a sample pad, a lining, and a rubber plate. The T line (inspection line) of the nitrocellulose membrane is coated with the ACE2 protein, the c line (quality control line) is coated with the antibody of the quality control line, and the R line (control line) is coated with a large group of antibodies. The set pad is coated with 2019 ncov antigen.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


2-30 ℃ for 12 months.
The validity period of aluminum foil is 1 hour after opening.
Configuration number: see label for details.
Deadline: please refer to the label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. Precipitates and suspended matter in the sample affect the experimental results and must be removed by centrifugation.
3. Anticoagulant: The use of anticoagulants such as jellyfish skin, EDTA and sodium citrate has little effect.
4. Blood collection should be done by a medical professional. Priority is given to serum / plasma tests. In emergencies and special cases, the patient's entire blood sample can be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature should not exceed 8 hours. It can be stored at temperatures between 2 ° C and 8 ° C for 6 months, 5 days or shorter, up to 20 ° C, but repeated freeze-thaw cycles should be avoided. The freezing time of whole blood specimens should be 48 hours to 8 ° C or less.

Test Method


Please read the guide carefully before the exam. Allow all study agents to cool to room temperature before testing. The test should be conducted at room temperature.
1. Remove the test card from the test pack and use it within 1 hour.
Add the sample to the buffer solution (about 2 μl) and add the sample to the buffer solution (about 2 μl).
3. Reaction time at room temperature is 10 to 15 minutes. After 20 minutes, the result was invalid.

Interpretation of Test Results


2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus

Result judgment chart of test card:

1. Invalid result: There is no response line on the quality control line (C line). The test is invalid and needs to be re-experimented.
2. Negative result: Red streaks appear on the test line (t line), and the color development rate is higher than that of the control line (r line), quality control line (C line), and control line (r line).
3. Positive result: There is no red belt in the test line (t line), or there is a red belt in the test line (t line), but the color development rate is lower than that of the control line (r line) and the quality is deteriorated. Control line (C line) and control line (r line).

Limitation of Test Method


1. This device is used only for in vitro diagnosis.
2. Appropriate amount of sample must be added to perform the test. Too many or too few samples will result in inaccurate results.
3. Hemolysis, blood fats, jaundice, and contaminated samples can affect test results and should be avoided.
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 must be based on a comprehensive assessment of all clinical and laboratory results.

Product Performance Indicators


1. Specificity analysis
1.1 cross reaction: the following types of antibody evaluation were conducted for interference with reagents, and no cross reaction occurred.

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 new coronavirus (2019 ncov) neutralizing antibody test item evaluates the potential interference of the following substances by adding the following substances to a sample of a specific concentration. As a result, it was clarified that each interfering substance did not interfere with the detection result of the 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 and 300 negative samples were selected from Novell coronavirus (2019 nCoV) IgG test reagents (colloidal gold method) as controls. The results are summarized below.

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum

Positive Negative

2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus

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. This product cannot be used after it has been built.
3. Before you start, please read the operation manual carefully and experiment according to the reagent manual.
4. Do not conduct experiments in adverse environments such as disinfectants, sodium hypochlorite, alkali acid, acetaldehyde, other corrosive gases and dusty environments. After the experiment is over, the laboratory must be disinfected.
5. All samples and reagents used are considered potential contagious substances and should be disposed of in accordance with local regulations.
6. Reagents must be used within the expiration date indicated on the packaging. Use the sensor card to remove it from the aluminum foil bag as soon as possible to prevent moisture.

Company profile


2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus
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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