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BetaCoronavirus Sars-Cov-2 Neutralization Antibody Test Immunochromatography

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BetaCoronavirus Sars-Cov-2 Neutralization Antibody Test Immunochromatography

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Brand Name : ZOSBIO

Model Number : 2019-NCoV Neutralizing Antibody

Certification : CE BfArm

Place of Origin : 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)

Package specification : 1Test/kit,5Tests/kit,10Tests/kit,20Tests/kit,25Tests/kit,50Tests/kit,100Tests/kit.

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)


Intended Use


The kit is used for the qualitative detection of 2019-nCoV neutralizing Ab in human serum,plasma, and whole blood samples.
As a new type, 2019-nCOV is a kind of β-COVs. It can cause viral pneumonia, with main clinical manifestations of fever, fatigue and dry cough. A few patients are accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases often develop
dyspnea and/or hypoxemia after a week, and those at serious condition rapidly progress to acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, and coagulation dysfunction

Principle of Detection



The kit uses immunochromatography. The test card contains quality control line C, test line T and reference line R. The sample to be tested (serum/ plasma/ whole blood) diffuses upwards by capillary action at the loading well, and S-RBD of the maker in the binding pad binds to the immobilized ACE2 protein on the NC membrane, and the signal can be detected at the position of T line. If there is neutralizing antibody in the sample, it will bind to the labeled S-RBD antigen when flowing through the labeling pad. The neutralizing antibody can prevent the binding of S-RBD toACE2,resulting in a decrease in the signal value, and 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 reference 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 foruality control. If there is no color display on C line, the test is invalid and the sample must bere-tested

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. Among them, the test strip is composed of absorbent paper, nitrocellulose membrane, sample pad,binding pad and rubber sheet. The nitrocellulose membrane T line (test line) is coated

with ACE2 protein, the C line (quality control line) is coated with Ab on quality control line, the R line (reference line) is coated with reference Ab, and the binding pad contains marker-labeled 2019-nCoV Ab.
Sample buffer: Phosphate, sodium azide, etc.

Storage Conditions and Validity


Keep it at 2℃ ~ 30℃, and the validity period is set at 12 months.
The validity period is an hour for aluminum foil bag being unpacked.
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, andshould be removed by centrifugation.

3. Anticoagulant: Heparin, EDTA and sodium citrate anticoagulant have no significant effect.

4. Blood collection should be performed by professional medical personnel. It is recommended to give priority to serum/plasma test. In emergency or special circumstances, the patient's whole blood sample can also be used for rapid test.

5. Serum and plasma samples should not be stored at room temperature for more than 8h. They can be stored for 5 days at 2℃ to 8℃ and for 6 months below -20℃, but repeated freeze-thaw cycles should be avoided. Whole blood samples should not be frozen and it should be stored at 2℃~8℃ for no more than 48h


Test Method


Read the instructions carefully before testing. Please return all reagents to room temperature before testing, and the test should be performed at room temperature.

1.Take out the test card from the packaged reagent bag and use it within an hour.

2.Add 20μL of sample (serum, plasma or whole blood) to the loading well of the test card, then add 2 drops (about 60μL) of sample buffer and then start timing.

3. Read the result when reacting at room temperature for 10-15 minutes. The result is invalid after 20 minutes


Interpretation of Test Results



Interpretation of test card:

  1. Invalid result: It is invalid with no reaction line on the quality control line (C line), and the test should be carried out again.
  2. Negative result: A red band appears on the test line (T line), and the color rendering is higher than or equal to the reference line (R line), and the quality control line (C line) and reference line (R line) are colored.
  3. Positive result: No red band appears on the test line (T line), or the red band on the test line (T line) is less coloring than the reference line (R line), and the quality control line (C line) and the reference line (R Line) are colored.

Limitation of Test Method



  1. This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
  2. Make sure to add an appropriate amount of sample for test. Too much or too little sample volume may result in 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

1.1Cross 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

1.2Interfering substances: The following concentrations of substances were added to the samples at the specified concentrations to evaluate their potential interference in 2019-nCoV neutralization Ab test project. The results showed that all kinds of interfering substances did 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 study: Using the marketed 2019-nCoV IgG Ab 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 gold

method)


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 disposable, which cannot be recycled and reused.
  3. Read the instructions carefully before operation, and carry out the experimental operation in strict accordance with the reagent instructions.
  4. Avoid conducting experiments in bad environmental conditions (the environments containing 84 disinfectant, sodium hypochlorite, high-concentration corrosive gases such as acid and alkali or acetaldehyde, and dust). Laboratory disinfection should be carried out after 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 test card should be used as soon as possible after being 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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