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COVID-19 Neutralizing Antibody Rapid Test Immunochromatography Storage Conditions

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COVID-19 Neutralizing Antibody Rapid Test Immunochromatography Storage Conditions

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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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(COVID-19) Neutralizing Antibody Rapid Test (Immunochromatography) Storage Conditions And Validity


Intended Use


The kit is used for qualitative detection of 2019-nCoV neutralization technology

Antibodies in human serum, plasma and whole blood samples.

As a new machine, 2019-nCOV is a kind of β-COV. It can cause viral pneumonia, and its main clinical manifestations are fever, fatigue and dry cough. A few patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe cases usually have dyspnea and/or hypoxemia one week later, and severe cases will rapidly develop into acute respiratory distress syndrome, septic shock, intractable metabolic acidosis and coagulation dysfunction.

NCoV in 2019 has several structural proteins, including spike (S), envelope (E) and membrane
(m) and nuclear contact (n). Peak protein contains a receptor binding domain (RBD), which is responsible for recognizing angiotensin converting enzyme 2(ACE2) on cell surface receptor. It is found that RBD of spike protein in 2019-nCoV interacts strongly with human ACE2 receptor, which leads to endocytosis of lung host cells and virus replication.

2019-n cobaltous acid virus infection or vaccination will trigger an immune response and produce antibodies in blood. These secreted antibodies can prevent virus infection. They will exist in human circulatory system for several months to several years after infection, and will combine with pathogens quickly and firmly to prevent virus replication. These antibodies are called neutralizing antibodies. Neutralizing antibody test can determine whether a person has the ability to prevent virus infection.

Principle of Detection



The kit uses immunochromatography. The test card includes quality control line C, test line T and reference line R. The sample to be tested (serum/blood/whole blood) diffuses upward at the loading well through capillary action. The S-RBD of the binding pad manufacturer binds with ACE2 protein fixed on NC membrane, and detects the signal at the position of T line. If the neutralizing antibody exists in the sample, it will bind to the labeled S-RBD antigen when flowing through the labeled pad. Neutralizing antibody can prevent S-RBD from binding to ACE2, which leads to the decrease of signal value. The signal value of T line is negatively correlated with the content of neutralizing antibody. When the concentration of neutralizing antibody is high enough, there is no color on T line. The reference line r and the quality control line c should be colored, whether the t line is colored or not. The 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 retested.

Main Components


The kit consists of a test card and a sample buffer.
Test card: It consists of aluminum foil bag, desiccant, test strip and plastic card. The test strip consists of absorbent paper, nitrocellulose membrane, sample pad, adhesive pad and rubber sheet. T-line (test line) of nitrocellulose membrane is coated with ACE2 protein, C-line (quality control line) is coated with Ab, R-line (reference line) is coated with reference Ab, and the bonding plate contains the label 2019-nCoVAb.
Sample buffer: phosphate, sodium azide, etc.


Storage Conditions and Validity


Keep it at 2℃~30℃ and set the validity period to 12 months.

The validity period of the aluminum foil bag is one hour.

LotNo.: for details, see the label.
Expiry date: see the label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in samples may affect the experimental results and should be removed by centrifugation.
3. Anticoagulants: heparin, EDTA and sodium citrate had no significant effect.
4. Blood collection should be carried out by professional medical personnel. It is recommended to give priority to serum/plasma test. In case of emergency or special circumstances, the whole blood sample of patients can also be used for rapid detection.
5. The storage time of serum and plasma samples at room temperature shall not exceed 8 hours. They ..
It can be stored at 2℃ to 8℃ for 5 days and below -20℃ for 6 months, but repeated freeze-thaw cycles should be avoided. Whole blood samples should not be frozen and stored at 2℃~8℃ for no more than 48 hours.

Test Method


Please read the instructions carefully before testing. Please reduce all reagents to room temperature before the test, and the test should be carried out at room temperature.
1. Take out the test card from the packaged reagent bag and use it within one hour.
2. Add 20μL sample (whole serum and plasma), then add 2 drops (about 60μL) of sample buffer, and then start timing.
3. Please read the results when reacting for 10-15 minutes at room temperature. After 20 minutes, the result is invalid.

Interpretation of Test Results



Figure for judging test card results:

1. invalid result: there is no reaction line on the quality control line (line c), which is invalid, and the test should be carried out again.
2. Negative result: the red band appears on the test line (T line), the color 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 results: the test line (T line) has no red band, which is smaller than the reference line (R line), and the quality control line (C line) and reference line (R line) are colored.

Limitation of Test Method



1. This kit is used for qualitative detection, only for in vitro auxiliary diagnosis.
2. Make sure to add an appropriate number of samples for testing. Too much or too little sample size may lead to inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect the test results, so these samples should be avoided.
4. The test results of this reagent are for clinical reference only, and should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis should be made after comprehensive evaluation and laboratory results of all clinical practices.

Product Performance Indicators


1. Analysis of specificity
1.1 1.1 Cross-reaction: The following types of antibody interference reagents were evaluated, and the results showed that there was 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: Add the following substances to the samples at specific concentrations to evaluate their potential interference in 2019-nCoV and Ab test projects. 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 research: 120 positive samples and 300 negative samples were selected for detection with the listed 2019-nCoVIgGAb detection reagent (colloidal gold method) as the comparative reagent. The research 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 disposable and cannot be recycled and reused.
3. Read the instructions carefully before operation, and carry out experimental operation in strict accordance with the reagent instructions.
4. Avoid testing under severe environmental conditions (including 84 kinds of disinfectants, sodium hypochlorite, high concentration corrosive gases such as acid and alkali or acetaldehyde and dust). After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be regarded as potentially infectious substances and disposed of according to local laws and regulations.
6. Reagents should be used within the validity period marked on the outer packaging. After taking it out of the aluminum foil bag, use the test card as soon as possible to prevent moisture.

Logo interpretation




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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