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ZOSBIO 2019-Ncov Neutralization Antibody Test Kit

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ZOSBIO 2019-Ncov Neutralization Antibody Test Kit

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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

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2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Principle Of Detection


Intended Use


This kit is used for the qualitative detection of new coronavirus (2019-nCoV) neutralizing antibodies in human serum, plasma, and whole blood samples.
The new type of coronavirus (2019-nCoV) is a new type of coronavirus, belonging to the beta genus of coronaviruses. It can cause viral pneumonia. The clinical manifestations are mainly fever, fatigue, and dry cough. A few patients are accompanied by nasal congestion, runny nose, sore throat and diarrhea. Severe cases often develop dyspnea and/or hypoxemia within a week, and severe cases rapidly progress to acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, and coagulation dysfunction.
The new coronavirus has several structural proteins, including spikes (S), envelope (E), membrane (M) and nucleocapsid (N). Among them, the spike protein contains a receptor binding domain (RBD), which is responsible for recognizing the cell surface receptor angiotensin converting enzyme 2 (ACE2). Studies have found that the RBD of the 2019-nCoV spike protein strongly interacts with the human ACE2 receptor, which in turn leads to the endocytosis and virus replication of host cells in the lung.
2019-nCoV infection or vaccination will trigger an immune response and produce antibodies in the blood. The secreted antibodies can prevent virus infection. They will exist in the human circulatory system for months to years after infection, and will quickly and firmly bind to pathogens to prevent virus replication. These antibodies are called neutralizing antibodies. Neutralizing antibody testing can determine whether people have this ability to prevent viral infections.

Principle of Detection



This kit uses immunochromatography. The test card contains quality control line C, test line T and control line R. The sample to be tested (serum/plasma/whole blood) diffuses upwards by capillary action at the sample end, and the binding pad contains S-RBD and NC membranes containing markers On the immobilized ACE2 protein binding, the signal can be detected at the position of the T line. If there is a neutralizing antibody in the sample, it will bind to the labeled S-RBD antigen when it flows through the labeling pad. The neutralizing antibody can prevent the binding of S-RBD to ACE2, causing the signal value to decrease, and the T-line signal value and neutralization The antibody content is negatively correlated. When the neutralizing antibody concentration is high enough, the T-line will not show color. Regardless of whether the T line is colored or not, the control line R and the quality control line C should be colored. The quality control line C is used for quality control. If the C line has no color, it means that the test is invalid and the sample must be tested again.

Main Components


The kit consists of a test card and 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, bonding pad, and rubber sheet. Nitrocellulose membrane T line (detection line) is coated with ACE2 protein, C line (quality control line) is coated with quality control line antibody, R line (control line) is coated with control antibody, and the binding pad contains markers 2019-nCOV antigen.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


It can be stored at 2 ℃ to 30 ℃ for 12 months.
After the aluminum foil bag is unsealed, it is valid for 1 hour.
Product batch number: see label for details.
Expiration date: see label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample may affect the results of the experiment and should be removed by centrifugation.
3. Anticoagulant: The use of heparin, EDTA and sodium citrate anticoagulant has no significant effect.
4. Blood collection should be performed by professional medical personnel. It is recommended to give priority to serum/plasma testing. In emergency or special circumstances, the 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 8 hours. They can be stored at 2°C to 8°C for 5 days, and at -20°C they can be stored for 6 months but avoid repeated freezing and thawing. Whole blood samples should not be frozen and stored at 2℃~8℃ for no more than 48h.


Test Method


Read the instruction manual carefully before testing. Please return all reagents to room temperature before the test, and the test should be performed at room temperature.
1. Take out the test card from the packaged reagent bag and use it within 1 hour.
2. Add 20μL of sample (serum, plasma or whole blood) to the sample hole of the test card, and then add 2 drops (about 60μL) of sample buffer to start timing.
3. Read the result when reacting at room temperature for 10-15 minutes. The read result is invalid after 20 minutes.


Interpretation of Test Results



Test card result judgment icon:
1. Invalid result: the quality control line (line C) has no response line, and the test is invalid. The experiment should be repeated.
2. Negative result: A red band appears on the test line (T line), and the color is higher than or equal to the control line (R line), and the quality control line (C line) and control line (R line) are colored.
3. Positive result: there is no red band on the test line (T line) or red band on the test line (T line), but the color is lower than the control line (R line), the quality control line (C line) and the control line (R Line) color development.

Limitation of Test Method



1. This kit is a qualitative test and is only used for in vitro auxiliary diagnosis.
2. Make sure to add an appropriate amount of sample for testing. Too much or too little sample size may cause inaccurate results.
3. Hemolysis, lipemia, jaundice and contaminated samples may affect the test results, and these samples should be avoided.
4. The test results of this reagent are for clinical reference only, 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.

Product Performance Indicators


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.


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: The following substances were added to the specified concentration samples to evaluate their potential interference in the new coronavirus (2019-nCoV) neutralization antibody test project. The results show that various interfering substances will not interfere with the test results of this reagent.


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 research: Using the marketed new coronavirus (2019-nCoV) IgG antibody detection reagent (colloidal gold method) as a comparison reagent, 120 positive samples and 300 negative samples were selected for testing. The results are summarized as follows:


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


1. This product is only used for in vitro diagnosis.
2. This product is a one-time use product, after use, it cannot be recycled and reused.
3. Read the instruction manual carefully before operation, and carry out the experimental operation in strict accordance with the reagent manual.
4. Avoid conducting experiments in harsh environments (such as environments containing 84 disinfectant, sodium hypochlorite, acid-base or acetaldehyde and other high-concentration corrosive gases and dust) conditions. Laboratory disinfection should be performed after the experiment.
5. All samples and reagents after use should be regarded as potentially infectious substances, and should be disposed of in accordance with local regulations when they are discarded.
6. Please use the reagents within the validity period indicated on the outer packaging, and use the test card as soon as possible after taking it out of the aluminum foil bag to prevent moisture.

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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

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European Community

Manufacturer

Basic Information


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


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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