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SARS-CoV-2 Coronavirus Neutralizing Antibody Rapid Test

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SARS-CoV-2 Coronavirus Neutralizing Antibody Rapid Test

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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) Storage Conditions And Validity


Intended Use


This kit is used for the qualitative detection of novel coronavirus (2019-nCoV) neutralizing antibodies in human serum, plasma and whole blood samples.
Novel coronavirus (2019-NCoV) is a novel coronavirus belonging to the genus β. Can cause viral pneumonia, clinical manifestations with fever, fatigue, dry cough, a few patients with nasal congestion, runny nose, sore throat and diarrhea and other symptoms. In severe cases, dyspnea and/or hypoxemia usually develop after a week, and in severe cases, rapid progression to acute respiratory distress syndrome, septic shock, refractory metabolic acidosis, and haemorrhagic dysfunction.
Novel coronavirus has several structural proteins, including spikes (S), envelopments (E), membranes (M), and nucleocapsids (N). The spikes contain a receptor binding domain (RBD) that recognizes the cell surface receptor angiotensin-converting enzyme 2 (ACE2). We found that RBD of the 2019-nCoV spike protein strongly interacts with the human ACE2 receptor, leading to endocytosis of host cells and viral replication in the lung.
2019-nCoV infection or vaccination triggers an immune response that produces antibodies in the blood. They remain in the body's circulatory system for months to years after infection and bind quickly and firmly to the pathogen, preventing the virus from replicating. These antibodies are called neutralizing antibodies. A neutralizing antibody test can determine whether a person has this ability to prevent infection.

Principle of Detection



This kit is immunochromatographic. 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 upward through capillary action at the sampling end. S-RBD containing markers in the binding pad binds to the ACE2 protein immobilized on the NC membrane, and the signal can be detected at the T line position. If there is a neutralizing antibody in the sample, it will bind to the labeled S-RBD antigen when passing through the labeling pad. The neutralizing antibody can prevent the binding of S-RBD to ACE2, resulting in a decrease in the signal value. The T-line signal value is negatively correlated with the neutralizing antibody content, and when the neutralizing antibody concentration is high enough, there is no color on the T-line. The control line R and quality control line C should be colored regardless of whether T line is colored or not. Quality control line C is used for quality control. If there is no color display on line C, the test is invalid and the sample must be re-tested.

Main Components


The kit consists of a test card and a 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, binding pad and rubber plate. Nitrocellulose membrane T line (test line) was coated with ACE2 protein, C line (quality control line) was coated with quality control line antibody, R line (control line) was coated with control antibody, and the binding pad contained marker labeled 2019-nCoV antigen.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


Store at 2℃ ~ 30℃ for 12 months.
The validity period of the aluminum foil bag is 1h after unpacking.
Batch No. : 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 experimental results, and should be removed by centrifugation.
3. Anticoagulants: the use of heparin, EDTA and sodium citrate anticoagulants had no significant effect.
4. Blood collection should be performed by medical professionals. Serum/plasma testing is recommended as a priority. In emergency or special circumstances, a 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 8h. They can be stored at 2℃ to 8℃ for 5 days and below -20℃ for 6 months, but repeated freeze-thaw cycles should be avoided. The whole blood sample shall not be frozen and stored at 2℃ ~ 8℃ for no more than 48h.


Test Method


Read the instructions carefully before the test. Restore all reagents to room temperature before testing. The test should be conducted at room temperature.
1. Take the test card out of the packaged reagent bag and use it within 1 hour.
2. Add 20μl sample (serum, plasma or whole blood) to the filling well of the test card, then add 2 drops (about 60μl) sample buffer, and start timing.
3. Reaction at room temperature for 10 ~ 15 minutes to read the results. The result was invalid after 20 minutes.


Interpretation of Test Results



Judgment diagram of test card results:
1. Invalid results: no reaction line appeared on the quality control line (line C), and the test was invalid, so the experiment should be redone.
2. Negative results: red bands appear on the test line (Line T), and the color rendering is higher than or equal to the control line (Line R), quality control line (Line C) and control line (Line R).
3. Positive result: no red band appeared on the test line (Line T) or red band appeared on the test line (Line T), but the color rendering was lower than that of the control line (Line R), and the quality control line (Line C) and the control line (Line R).

Limitation of Test Method



1. This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
2. Make sure you add the right amount of samples for testing. Too many or too few samples may result in inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect test results and should be avoided.
4. The test results of this reagent are only for clinical reference 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 potential interference of the following substances in the Novel Coronavirus (2019-nCoV) neutralizing antibody test program was evaluated by adding the following substances to a specified concentration sample. The results showed that all kinds of interfering substances did not interfere with the detection 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 study: 120 positive samples and 300 negative samples were selected by using the marketed Novel Coronavirus (2019-nCoV) IgG detection reagent (colloidal gold method) as the contrast reagent, and the results were 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 disposable product, which can not be recycled and reused after use.
3. Read the operation instructions carefully before operation, and carry out the experiment in strict accordance with the reagent instructions.
4. Avoid conducting the experiment in harsh environment (such as environment containing high concentration of corrosive gas and dust such as 84 disinfectant, sodium hypochlorite, acid and alkali or acetaldehyde). Laboratory disinfection should be carried out after the end of the experiment.
5. All samples and used reagents should be regarded as potentially infectious substances and disposed of in accordance with local regulations.
6. Reagents should be used within the validity period marked on the outer package. The detection card should be used as soon as possible after it is taken 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

Authorized representative in the

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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