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ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Henan Lantian Medical Supplies Co.,Ltd.

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

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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)

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

Tel : +86-371-55016575

Contact Now

2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Intended Use

Intended Use


A novel coronavirus (2019-nCoV) neutralizing antibody in human serum, plasma and whole blood samples is qualitatively tested.

New Coronavirus (2019-nCoV) is a new type of coronavirus. β A coronavirus of the genus. Can cause viral pneumonia, clinical manifestations of fever, fatigue, dry cough, a few patients with nasal congestion, runny nose, sore throat and diarrhea and other symptoms. In severe cases, dyspnea and / or hypoxemia occurred one week later. In severe cases, acute respiratory distress syndrome, septic shock, uncorrectable metabolic acidosis and coagulation dysfunction rapidly developed.

New Coronavirus has several structural proteins, including S, E, M and Nucleocapsid (N). Among them, spike protein contains a receptor binding domain (RBD), which is responsible for recognizing the cell surface receptor angiotensin converting enzyme 2 (ACE2). It is found that the RBD of 2019 ncov spike protein strongly interacts with human ACE2 receptor, which leads to endocytosis and viral replication of host cells in the lung.

2019 ncov infection or vaccination will trigger an immune response and produce antibodies in the blood. Secreted antibodies can prevent virus infection, they will exist in the human circulatory system for months to years after infection, and will quickly and firmly bind with pathogens, thus preventing virus replication. These antibodies are called neutralizing antibodies. Detection of neutralizing antibodies can determine whether people have the ability to prevent virus infection.

Principle of Detection


Immunochromatography was used in this kit. The test card consists of quality control line C, test line T and control line R. the sample to be tested (serum / plasma / whole blood) diffuses upward by capillary action at the sampling end. The s-rbd containing the marker in the binding pad binds to the ACE2 protein immobilized on the NC membrane, and the signal can be detected at the T-line position. If there is neutralizing antibody in the sample, it will bind to the labeled s-rbd antigen when flowing through the labeling pad. Neutralizing antibody can prevent the binding of s-rbd and ACE2, resulting in 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, T-line has no color development. The control line R and quality control line C should be colored no matter whether the T line is colored or not. Quality control line C is used for quality control. If no color development in line C means that the test is invalid, the sample must be retested.

Main Components


The kit is composed of a detection card and a sample buffer.

Test card: it is composed of aluminum foil bag, desiccant, paper strip and plastic card. The paper strip is composed of absorbent paper, nitrocellulose film, sample pad, bonding pad and rubber plate. The T-line (detection line) of cellulose nitrate membrane is coated with ACE2 protein, line C (quality control line) is coated with antibody of quality control line, r line (control line) is covered with control antibody, and 2019 ncov antigen with marker mark is attached to the pad.

Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


It can be stored at 2 ℃ to 30 ℃ for 12 months.

After the aluminum foil bag is unsealed, it is valid for 1 hour.

Product batch number: 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 and should be removed by centrifugation.

3. Anticoagulants: heparin, EDTA and sodium citrate had no significant effect on anticoagulants.

4. Blood collection should be carried out by professional medical personnel. It is recommended that serum / plasma should be tested first. In emergency or special cases, whole blood samples of patients can also be used for rapid detection.

5. Serum and plasma samples should not be stored for more than 8 hours at room temperature, 5 days at 2 ℃~ 8 ℃ and 6 months at - 20 ℃ without repeated freezing and thawing. The whole blood samples should not be frozen and stored at 2 ℃ - 8 ℃ for more than 48 hours.

Test Method


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

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

2. Add 20 drops to the sample adding hole of the test card μ L sample (serum, plasma or whole blood), then add 2 drops (about 60 ml) μ 50) Sample buffer, start timing.

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

Interpretation of Test Results


ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

The results of the test card are as follows:

1. Invalid result: there is no reaction line in the quality control line (line C), and the test is invalid, so the experiment should be repeated.

2. Negative results: the detection line (t line) appeared red band, and the color was higher than or equal to the control line (r line), quality control line (C line) and control line (r line).

3. Positive results: there was no red band in the test line (t line) or red band in the test line (t line), but the color development was lower than that of the control line (r line), and the color development of the quality control line (C line) and the control line (r line).

Limitation of Test Method


1. The kit is qualitative and only used for in vitro auxiliary diagnosis.

2. Please make sure to add the right amount of samples for testing. Too many or too few samples may lead to inaccurate results.

3. Hemolysis, lipidemia, 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 of the disease should be made after comprehensive evaluation of all clinical and laboratory results.

nsive evaluation of all clinical and laboratory results.

Product Performance Indicators


1. Analysis of specificity

1.1 cross reaction: the interference evaluation of the following types of antibodies with reagents showed that there was no cross reaction.

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 interference substance: the following concentration substances were added into the specified concentration samples, and the potential interference in the New Coronavirus (2019-nCoV) neutralization antibody test items was evaluated. The results showed that various interfering substances would not interfere with 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 research: using the New Coronavirus (2019-nCoV) IgG antibody test reagent (colloidal gold method) as the contrast reagent, 120 positive samples and 300 negative samples were detected respectively. The results were summarized as follows:

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum

Positive Negative

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

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 a one-time use product, which cannot be recycled after use.

3. Read the operation manual carefully before operation, and carry out the experimental operation in strict accordance with the reagent manual.

4. Avoid to carry out the experiment in the bad environment (such as the environment containing 84 disinfectant, sodium hypochlorite, acid-base or acetaldehyde and other high concentration corrosive gas and dust). The laboratory disinfection should be carried out after the end of the experiment.

5. All samples and used reagents should be regarded as potentially infectious substances, and should be disposed of in accordance with local regulations.

6. The reagent should be used within the validity period marked on the outer package. The test card should be used as soon as possible after it is taken out of the aluminum foil bag to prevent moisture.

Logo interpretation


ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Do not re-use

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Store at 2℃~30℃

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Consult instructions for use

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

In vitro diagnostic medical

device

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Batch code

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Use-by date
ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit Keep dry

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Keep away from sunlight

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

Authorized representative in the

European Community

ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit

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


ZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/KitZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/KitZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/KitZOSBIO Coronavirus Neutralizing Antibody Rapid Test 1Test/Kit To 100Tests/Kit
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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