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OEM ODM Covid Neutralizing Antibody Test Kit For Covid-19

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OEM ODM Covid Neutralizing Antibody Test Kit For Covid-19

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Brand Name : ZOSBIO

Model Number : 2019-NCoV Neutralizing Antibody

Certification : CE BfArm

Place of Origin : Henan,China

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 : twelve months

Sample requirements : Serum, plasma or whole blood

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2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Limitation Of Test Method


Intended Use


This kit is used for qualitative detection of 2019 ncov neutralization
Antibodies in human serum, plasma and whole blood samples.
As a new type, 2019 ncov is a kind of β- Cov. It may cause viral pneumonia, and the main clinical symptoms are fever, fatigue and dry cough. Several patients are accompanied by nasal congestion, runny nose, throat pain, diarrhea and other symptoms. Severe cases often develop respiratory distress and / or hypoxemia after a week, and serious cases rapidly progress to acute respiratory distress syndrome, septic shock, difficult metabolic acidosis, and coagulation dysfunction.
2019 ncov has several structural proteins such as spike (s), envelope (E), and membrane
(m) and Nucleocapsid (n). Among them, the spike protein contains a receptor binding domain (RBD) involved in the recognition of angiotensin converting enzyme 2 (ACE2) on the cell surface receptor. Research shows that the RBD of the 2019 ncov spike protein strongly interacts with the human ACE2 receptor and causes endocytosis and virus replication in the host cells of the lung.
2019 NV infection or vaccination causes an immune response that produces antibodies in the blood. Secreted antibodies can prevent viral infections. They exist in the human circulatory system for several months to several years after infection, and quickly and securely bind to the pathogen to prevent viral replication. These antibodies are called neutralizing antibodies. Neutralizing antibody tests can determine if a person has the ability to prevent viral infections.

Principle of Detection



This element is immunochromatography. Test cards include quality control line C, detection line T, and control line R. The sample of the test (serum / plasma / whole blood) diffuses upward by capillary phenomenon after the sample is finished. S-rbd, which contains a binding pad sign, can be coupled to the ACE2 protein immobilized on the NC membrane 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 by a labeling pad. Neutralizing antibodies may prevent s-rbd from binding with ACE2 and reduce the signal value. The T-line signal value had a negative correlation with the neutralizing antibody content. If the neutralizing antibody concentration is high enough, the T line does not color. Control line R and horizontal control line C are colorized regardless of the color of the T line. Quality control line C is used for quality control. If the c-line has no color display, the test is disabled and the sample must be retested.

Main Components


The kit consists of a test card and a sample buffer.
Test cards: aluminum foil bag, desiccant, test strip and plastic cards. The strip is made up of absorbent, nitrocellulose membrane, sample pad, inner liner and rubber plate. The T line (detection line) of the nitrocellulose membrane was coated with the ACE2 protein, the C line (quality control line) was coated with the antibody of the quality control line, and the R-line was coated with a large antibody. Group. Combination pad is coated with 2019 ncov antigen.
Sample buffer: phosphoric acid, sodium azide

Storage Conditions and Validity


12 months at 2 to 30 degrees Celsius.
Aluminum foil is valid for 1 hour after opening.
Configuration number: see the label for more information.
Deadline: please refer to the label for details.

Sample Requirements


1.Collect serum, plasma, or whole blood samples.
2.The precipitates and floats in the sample affect the experimental results, so they must be removed by centrifugation.
3.Use of anticoagulant: jellyfish skin, EDTA, sodium citrate anticoagulant has little effect.
4.Blood sampling should be done by a medical specialist. Serum / plasma test is the first choice. In case of emergency or special circumstances, you can perform rapid inspection using the whole blood sample of the patient.
5.Storage time of serum and plasma samples should not exceed 8 hours at room temperature. 2 ° C-8 ° Within 6 months, 5 days ° You can save it in C, but do not repeat the freeze thaw cycle. The freezing time of all blood samples must be 48 hours to 8 degrees Celsius.

Test Method


Read the instructions carefully before testing. Return all reagents to room temperature before the test. Examinations should be performed at room temperature.
1. Take the test card from the packaged reagent bag and use it within 1 hour.
2. Test well loading well μ Add a sample of L (serum, plasma, or whole blood) and then μ Add a sample buffer and start timing.
3. The result will be disabled after 20 minutes.


Interpretation of Test Results



Interpretation of test cards
1. Invalid results: the quality control line (C line) is invalid because there is no reaction line, and you need to do the test again.
2.Negative results: the red band appears in the test line (t line), the color rendering performance is the standard line (r line), the quality control line (C line) and the reference line (r line).
3.Positive results: the red band is not displayed on the test line (t line), and the red band of the test line (t line) is color coded from the reference line (r line) and the quality control line (C line), and the reference line (r line) is color coded.

Limitation of Test Method



This element is only used for in vitro diagnosis.
2. If the sample is too many or too small, the result is false.
3. Hemolysis, blood lipids, jaundice, and contaminated samples should be affected because they may affect the test results.
4.The results of a reagent test are for clinical reference and cannot be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease should 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.


SNItemCross reactionSNItemCross reaction
1Endemic human coronavirus OC43No10EnterovirusNo
2Endemic human coronavirus HKUINo11EB virusNo
3Endemic human coronavirus NL63No12Measles virusNo
4Endemic human coronavirus 229ENo13Human cytomegalovirusNo
5Influenza A virusNo14RotavirusNo
6Influenza B virusNo15NorovirusNo
7Respiratory syncytial virusNo16Mumps virusNo
8AdenovirusNo17Varicella-zoster virusNo
9RhinovirusNo18Mycoplasma pneumoniaeNo

1.2 interfering substances: in New Coronavirus (2019 ncov) neutralizing antibody test items, the potential interference of the following substances is assessed by adding the following substances in a specific concentration sample. The results show that all kinds of interfering substances will not interfere with the detection results of reagents.


Interfering substancesConcentrationInterfering substancesConcentration
Bilirubin≤50mg/dLTriglycerides≤15mmol/mL
Hemoglobin≤5g/LCholesterol L≤500mg/d
Rheumatoid factor≤500IU/mLHuman total IgG≤14mg/mL
Ribavirin0.4mg/mLFluticasone0.5mg/mL
Oxymetazoline10mg/mLDexamethasone5 mg/mL
Histamine hydrochloride10mg/mLTriamcinolone acetonide5mg /mL
Tobramycin1mg/mLLevofloxacin0.2 mg/mL
Oseltamivir1mg/mLAzithromycin0.1 mg/mL
Zanamivir1mg/mLCeftriaxone0.4 mg/mL
Arbidol0.5mg/mLMeropenem0.2 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

PositiveNegative

Positive1155120
Negtive5295300
Sum120300420
Sensitivity95.83%, (95%CI: 90.62%~98.21%)
Specificity98.33%, (95%CI: 96.16%~99.29%)

Precautions


This product is only used for in vitro diagnosis.
Cannot be used after disposal.
3. Before you begin, read the operation guide carefully and follow the reagent guide.
4. Disinfectant, sodium hypochlorite, acid-base, acetaldehyde, other corrosive gas, and environment in a harsh environment. After experimentation, it is necessary to disinfect in the laboratory.
5. All samples and reagents used are potentially potentially contagious and must be destroyed according to local regulations.
6. The reagent must be used within the validity period listed in the outer package. Use the guidance card as soon as possible to remove the card from the aluminum foil bag and prevent moisture.

Company profile


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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