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2019-NCoV Neutralizing Antibody Rapid Test ( Immunochromatography ) Main Components

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2019-NCoV Neutralizing Antibody Rapid Test ( Immunochromatography ) Main Components

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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) Main Components

Composition : Detection card, sample buffer

Packing Specification : 1Test/kit,5Tests/kit,10Tests/kit,20Tests/kit,25Tests/kit,50Tests/kit,100Tests/kit.

validity period : 12 months

Expiration date : See label for details.

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2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Main Components

Intended Use


The kit is used for the qualitative detection of New Coronavirus neutralizing antibodies in human serum, plasma and whole blood samples.
2019- New Coronavirus is a kind of New Coronavirus. β Coronavirus. It can cause viral pneumonia. The main clinical manifestations are fever, fatigue and dry cough. A few patients will also have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases usually develop dyspnea and / or hypoxemia after one week. Critical cases rapidly develop into acute respiratory distress syndrome, septic shock, uncorrectable metabolic acidosis and coagulation disorder.
New Coronavirus has a variety of structural proteins, such as envelope protein (S), envelope protein (E) and membrane protein.
Among them, spike protein contains a receptor binding domain (RBD), which is responsible for recognizing angiotensin converting enzyme 2 (ACE2) on cell surface receptors. It was found that the 2019-n coronavirus spike protein RBD interacted strongly with human ACE2 receptor, resulting in host cell endocytosis and virus replication in the lung.
New Coronavirus infection or vaccination can trigger immune responses and produce antibodies in the blood. Secreted antibodies can prevent viral infection. After infection, they will stay in the human circulatory system for months to years, and quickly and firmly combine with pathogens to prevent virus replication. These antibodies are called neutralizing antibodies. Neutralizing antibody tests can determine whether a person can prevent viral infection.

Principle of Detection


The kit uses immunochromatography. The test card includes quality control line C, test line T and reference line R. the capillary action load and binding of test samples (serum / plasma and whole blood) are combined with s-rbd manufacturer's pad. ACE2 is fixed in NC membrane protein to detect the position line and send a signal. If there is a neutralizing antibody in the sample, it will bind to the labeled s-rbd antigen when it flows through the labeling pad. Neutralizing antibody can prevent s-rbd from binding to ACE2, resulting in the decrease of signal value. The signal value of T-line was negatively correlated with the content of neutralizing antibody. When the antibody concentration is high enough, T-ray is colorless. The reference line R and the quality control line C are colored regardless of whether the T line is colored or not. Adopt product pipeline C
Quality Control. If there is no color display on the C line, 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 is composed of aluminum foil bag, desiccant, test strip and plastic card. The test strip is composed of absorbent paper, nitrocellulose film, sample pad, bonding pad and rubber plate. Nitrocellulose membrane t line (detection line) covers ACE2 protein, C line (quality control line) covers quality control line, r line (reference line) covers reference AB, and the binding pad contains label 2019 ncovab.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


The storage temperature is 2 ℃ ~ 30 ℃, and the validity period is 12 months.
The validity period of aluminum foil package is 1 hour.
Production batch.: See label for details.
Deadline: see the label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended solids in the sample may affect the experimental results and should be removed by centrifugation.
3. Anticoagulation: heparin anticoagulation, EDTA anticoagulation and sodium citrate anticoagulation have no obvious effect.
4. Blood collection shall be carried out by medical personnel. It is recommended to give priority to serum / plasma testing. In emergency or special cases, the patient's whole blood sample can also be used for rapid detection.
5. Serum and plasma samples were stored at room temperature for more than 8 hours. He / she / they
It can be stored at 2-8 ℃ for 5 days and below 20 ℃ for 6 months, but repeated freezing and thawing should be avoided. Whole blood samples should not be frozen and should be stored at 2 ℃ to 8 ℃ for no more than 48 hours.

Test Method


Please read the instructions carefully before testing. Return all reagents to room temperature before testing and test at room temperature.
1. Take out the test card from the packaged reagent bag and use it within one hour.
2. Replace 20 μ L sample (serum, plasma or whole blood) is added into the filling hole of the detection card, and 2 drops (~ 60 ml) are added μ 50) , start timing.
3. React at room temperature for 10-15 minutes and read the results. Invalid after 20 minutes.

Interpretation of Test Results


Test card Description:
1. Invalid result: the non response line (line C) on the quality control line is invalid and should be retested.
2. Negative result: the test line (t line) is displayed as a red bar, 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: there is no red band on the test line (t line), the color of the red band on the test line (t line) is less than the reference line (r line), and the quality control line (C line) and reference line (r line) are color.

Limitation of Test Method


1. This kit is used for qualitative detection and only for in vitro auxiliary diagnosis.
2. Ensure that an appropriate number of samples are added for testing. Too much or too little sample size will lead to inaccurate results.
3. Hemolysis, lipid, jaundice and contaminated samples may affect the 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 only basis for clinical diagnosis and treatment. The final diagnosis shall be made after a thorough evaluation of all clinical and laboratory results.

Product Performance Indicators


1. Specificity analysis
1.1.1 Cross-reaction: The following types of antibody interfering reagents were evaluated and no cross-reaction was found.

SN Item Cross reaction SN Item Cross reaction
1 Endemic human coronavirus OC43 No 10 Enterovirus No
2 Endemic human coronavirus HKUI No 11 EB virus No
3 Endemic human coronavirus NL63 No 12 Measles virus No
4 Endemic human coronavirus 229E No 13 Human cytomegalovirus No
5 Influenza A virus No 14 Rotavirus No
6 Influenza B virus No 15 Norovirus No
7 Respiratory syncytial virus No 16 Mumps virus No
8 Adenovirus No 17 Varicella-zoster virus No
9 Rhinovirus No 18 Mycoplasma pneumoniae No

1.2 Interfering Substances: The following substances were added to the sample at specific concentrations to assess their potential interference in the 2019 nCoV and Ab test items. The results showed that all kinds of interfering substances did not interfere the detection results of the reagent.

Interfering substances Concentration Interfering substances Concentration
Bilirubin ≤50mg/dL Triglycerides ≤15mmol/mL
Hemoglobin ≤5g/L Cholesterol L ≤500mg/d
Rheumatoid factor ≤500IU/mL Human total IgG ≤14mg/mL
Ribavirin 0.4mg/mL Fluticasone 0.5mg/mL
Oxymetazoline 10mg/mL Dexamethasone 5 mg/mL
Histamine hydrochloride 10mg/mL Triamcinolone acetonide 5mg /mL
Tobramycin 1mg/mL Levofloxacin 0.2 mg/mL
Oseltamivir 1mg/mL Azithromycin 0.1 mg/mL
Zanamivir 1mg/mL Ceftriaxone 0.4 mg/mL
Arbidol 0.5mg/mL Meropenem 0.2 mg/mL

2. Clinical study: 120 positive specimens and 300 negative specimens were selected for detection with the listed 2019 NCOVIGAB detection reagent (colloidal gold method) as the control reagent. The results are summarized as follows:

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum

Positive Negative

Positive 115 5 120
Negtive 5 295 300
Sum 120 300 420
Sensitivity 95.83%, (95%CI: 90.62%~98.21%)
Specificity 98.33%, (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.
3. Read the operating instructions carefully before operation and carry out the experimental operation in strict accordance with the reagent instructions.
4. Avoid testing under harsh environmental conditions (including 84 disinfectants, sodium hypochlorite, acid, alkali, acetaldehyde and other high concentration corrosive gases, dust, etc.) After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be considered as potentially infectious substances and treated in accordance with local regulations.
6. The reagent shall be used within the validity period indicated on the outer package. The test card shall be used as soon as possible after being taken out of the foil bag 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 technology Co., Ltd. is a high-tech enterprise specializing in the development, production and management of in vitro diagnostic products. In vitro diagnostic products developed by the company include POCT series, microbial series, biochemical series, immune series reagents and supporting instruments.
The company always adhere to the core concept of "fast, accurate, life", is committed to providing quality products and services for the society, to make contributions to human health.


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