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2019 Beta-Cobs Covid-19 Neutralizing Antibody Test Kit For Whole Blood

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2019 Beta-Cobs Covid-19 Neutralizing Antibody Test Kit For Whole Blood

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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) Product Performance Indicators


Intended Use


The kit is used for the qualitative detection of 2019ncov neutralization
AB of human serum, plasma and whole blood samples.
As a new type of 2019β-cobs, it may cause viral pneumonia, and its main clinical symptoms are fever, fatigue and dry cough. Some patients will also be accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe cases often develop dyspnea and hypoxemia within a week, and rapidly develop into acute respiratory distress syndrome, septic shock, metabolic acidosis, and coagulopathy.
2019 NCOV has several structural proteins, including nail (S), envelop (E) and membrane.
(m) and nucleotide capsids (n). Among them, the spike protein contains a receptor binding domain (rbd), which is involved in the recognition of angiotensin converting enzyme 2 (ace 2) on cell surface receptors. Studies have found that the spike protein RBD of 2019 NCoV is very strong, and it interacts with human ACE 2 receptors, leading to endoplasmic cell apoptosis and virus replication in lung host cells.
In 2019, NCOV infection or vaccination will trigger an immune response and produce antibodies in the blood. The secreted antibodies can prevent viral infections. They exist in the human circulatory system several months to several years after infection, and quickly and reliably combine with pathogens in order to prevent virus replication. These antibodies are called neutralizing antibodies. The neutralizing antibody test can determine whether a person has the ability to resist viral infections.

Principle of Detection



The kit uses imno chromatography. The test card includes quality management line C, test line T, and reference line R. The test reagent (serum/plasma/whole blood) diffuses upward in the loading trap through capillary action, and the s-rbd of the binding pad manufacturer binds to the solidified aceo 2 protein on the nc membrane, and the signal can be detected at the position of the t line. If the neutralizing antibody is present in the sample, it will bind to the S-RBD antigen on the label when it passes through the label. The neutralizing antibody prevents S-RBD from binding to ACE 2, resulting in a decrease in signal value. The signal value of the 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 the T line. Regardless of whether the T line is colored, the reference line R and the quality management line C are colored. Quality Management Line C
If there is no color in the Uality control C line, the test is invalid and the sample must be tested again.

Main Components


The kit includes a test card and a sample buffer.
Test card: It is composed of aluminum foil bag, desiccant, test strip and plastic card. The test piece is composed of absorbent paper, nitrocellulose film, sample pad, adhesive pad, and rubber sheet. Nitrocellulose membrane T thread (detection thread) is coated with ACE 2 protein, C thread (quality control thread) is coated with AB protein, and R thread (reference thread) is coated with reference AB protein. The binding pad label is 2019 NCOV AB.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


2℃~ 30℃, the validity period is 12 months.

The validity period of the unpackaged aluminum foil bag is 1 hour.

Details: Please refer to the label.
Expiry date: Please refer to "Label" for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. The sediments and suspensions in the reagents have an impact on the experimental results and are removed by centrifugal separation.
3. Anticoagulant: heparin, EDTA, sodium citrate anticoagulant have no effect.
4. Blood collection should be done by professional medical personnel. It is recommended to give priority to serum and blood sample examinations. In emergency or special circumstances, the patient's whole blood sample can also be used for rapid testing.
5. Serum and plasma reagents should not be stored at room temperature for more than 8 hours. These 2 days can be stored for 5 days, the temperature reaches ℃ 8 ℃, and then the temperature reaches ℃ in the next 6 months, but repeated freezing and thawing cycles must be avoided. The whole blood sample cannot be frozen, and the temperature is 2℃~8℃ for more than 48 hours.

Test Method


Please read the instructions carefully before taking the exam. Please test all the reagents at room temperature to room temperature, and test at room temperature.
1. Take out the test card from the packaged reagent bag and use it within 1 hour.
2. Add L of the sample (serum, plasma or whole blood) in the loading well of the μ test card, followed by the start timing of adding 2 drops (approximately 60 drops of μL) of sample buffer.
3. Observe the result of the reaction for 10 to 15 minutes at room temperature. The result is invalid after 20 minutes.


Interpretation of Test Results



Explanation of the test card
1. Invalid result: The quality management line (line C) is invalid because there is no response line, and you need to retest.
2. Negative results: the red band is displayed on the test line (T line), and the color rendering is represented by the standard line (R line), the quality management line (C line) and the reference line (R line).
3. Affirmative result: display the red band on the test line (T line), color-code the red band of the test line (T line) from the reference line (R line) and the quality management line (C line), and put the reference line ( R line) coloring.

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: Due to the interference of reagents, the following types of antibodies were evaluated, and no cross-reactions occurred as a result.


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 the new coronavirus (2019ncov) neutralizing antibody test project, the potential interference of the following substances is evaluated by adding the following substances to a sample of a specific concentration. All kinds of interfering substances will not interfere with the test results of the 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 research: Use the 2019 ncov igg ab test reagents (colloidal gold method) that have been on the market as comparison reagents, and select 120 positive reagents and 300 negative reagents as tests. 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 biological in vitro diagnosis.
2. It cannot be used after being voided.
3. Before starting, please read the operating instructions carefully and follow the reagent instructions.
4. Disinfectant, sodium hypochlorite, acid and alkali solution, acetaldehyde, other corrosive gases and environment in harsh environment. After the experiment, it needs to be disinfected in the laboratory.
5. All samples and reagents used are potentially infectious and must be destroyed in accordance with local regulations.
6. Reagents must be used within the validity period indicated on the outer packaging. Remove the card from the aluminum foil bag to 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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