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Biosensor Coronavirus Neutralizing Antibody Rapid Test 2C - 30C Storage Conditions

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Biosensor Coronavirus Neutralizing Antibody Rapid Test 2C - 30C Storage Conditions

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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) Interpretation Of Test Results


Intended Use


The biosensor is used to detect neutralizing antibodies of New Coronavirus (2019 ncov) in human serum, plasma and whole blood samples.
COVID-19 (2019-ncov) β It belongs to New Coronavirus in vivo. It can cause viral pneumonia. Clinical symptoms include fever, fatigue, dry cough, etc. some patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe cases of dyspnea and / or hypoxemia usually occur within a week. Severe cases will develop rapidly due to acute dyspnea syndrome, septic shock, maladaptive metabolic acidosis and hemorrhagic dysfunction.
New Coronavirus has many structural proteins such as s, E, m and n. Spindles include receptor binding domains (RBDS) that recognize the cell surface. Receptor angiotensin converting enzyme 2 (ACE 2). We found that RBD of 2019 ncov tattoo protein has a strong interaction with human ACE2 receptor, which can induce virus replication in host cells and lungs.
New Coronavirus infection or vaccination can trigger an immune response and produce antibodies in the blood. After infection, they will stay in the human circulatory system for months to years. In order to prevent virus replication, they will quickly and closely combine with pathogens. This antibody is called neutralizing antibody. Neutralizing antibody test can determine whether people have the ability to prevent infection.

Principle of Detection



This element is immunochromatography. The test card includes quality management line C, detection line T and control line R. The sample to be tested (serum / plasma / whole blood) diffuses upward by capillary action after the sample is finished. S-rbd, including the labeling on the binding pad, binds to ACE2 protein fixed on the NC membrane, and the signal can be detected at the T-line position. When neutralization antibody is present in the sample, the s-rbd antigen on the label is bound by the labeling pad. Neutralization antibody can prevent s-rbd from binding with ACE2 and reduce signal value. The signal value of T-line was negatively correlated with the neutralization antibody content. If the neutralization antibody concentration is high enough, T-line will not have color. Control line R and horizontal management line C shall be colored regardless of the color of T-line. Quality management line C is used for quality management. If the c-line does not have a color display, the test is invalid and the sample needs to be retested.

Main Components


The kit consists of a test card and a sample buffer.
Test card: composed of aluminum foil bag, desiccant, test strip and plastic card. The strip consists of absorbent, nitrocellulose membrane, sample pad, inner liner and rubber plate. The T-line (detection line) of nitrocellulose membrane was coated with ACE2 protein, the c-line (quality management line) was coated with antibody of quality management line, and the R-line (contrast line) was coated with antibody of large group. The combination pad was coated with 2019 ncov antigen.
Sample buffer: phosphate, sodium azide, etc

Storage Conditions and Validity


2-30 ℃ for 12 months.
The validity period of aluminum foil is 1 hour after opening.
Configuration number: see label for details.
Deadline: please refer to the label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. Precipitates and floats in the sample affect the experimental results and must be removed by centrifugation.
3. Anticoagulants: Jellyfish skin, EDTA, sodium citrate The use of anticoagulants has little effect.
4. Blood sampling should be done by a medical professional. Serum / plasma testing is the first choice. In case of emergency or special circumstances, the patient's whole blood sample can be used for rapid examination.
5. The storage time of serum and plasma samples should not exceed 8 hours at room temperature. It can be stored in 2 ° C ~ 8 ° C 6 months, 5 days or less, ~ 20 ° C, but repeated freeze-thaw cycles should be avoided. Freezing time of whole blood sample should not be less than 48 hours ℃ -8 ℃.

Test Method


Please read the guide carefully before the exam. Please lower all tested drugs to room temperature before testing. The test shall be conducted at room temperature.
1. Remove the test card from the packaged test bag and use it within 1 hour.
2. 20 μ Add l sample (serum, plasma or whole blood) into the filling hole of the test card, and then drop 2 drops (about 60 drops) μ l) Add sample buffer and start timing.
3. The reaction time was 10-15 minutes at room temperature. The result was invalid after 20 minutes.


Interpretation of Test Results



Result judgment chart of test card:
1. Invalid results: the quality management line (C line) has no response line, the test is invalid, and the experiment needs to be carried out again.
2. Negative results: the detection line (t line) appeared red band, and its color rendering was higher than that of control line (r line), quality management line (C line) and control line (r line).
3. Positive results: the test line (t line) had no red band, or the test line (t line) had red band, but the color development was lower than that of the control line (r line), and the quality was decreased. Control line (C line) and control line (r line).

Limitation of Test Method



This element is only used for in vitro diagnosis.
2. In order to test, it is necessary to add an appropriate amount of sample. Too many or too few samples will lead to incorrect results.
3. Hemolysis, blood lipid, jaundice and contaminated samples may affect the test results and should be avoided.
4. Reagent test results are only for clinical reference, can not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease must be based on a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators


1. Specificity analysis
1.1 cross reaction: the following types of antibody evaluation were conducted for interference with reagents, and no cross reaction occurred.


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 New Coronavirus (2019 ncov) neutralizing antibody test items, the potential interference of the following substances is assessed by adding the following substances in a specific concentration sample. The results show that all kinds of interfering substances will not interfere with the detection results of 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 study: 120% positive and 300 negative samples were selected from Novell coronavirus (2019 nCoV) IgG test reagents (colloidal gold method) as controls. The results are summarized below.


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 used only for in vitro diagnosis.

This product cannot be used after it is thrown away.

3. Before you start, read the operating guide carefully and follow the reagent guide to perform the experiment.

4. Do not conduct experiments in harsh environments such as disinfectants, sodium hypochlorite, acid-base, acetaldehyde, other corrosive gases, and dusty environments. After the experiment, it must be disinfected in the laboratory.

5. All samples and reagents used are considered potentially contagious substances and should be destroyed according to local regulations.

6. Reagents must be used within the shelf life marked on the outer package. Use the induction card as soon as possible to remove it from the aluminum foil bag and 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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