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2019 NCoV Coronavirus Neutralizing Antibody Rapid Test Immunochromatography BfArm

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2019 NCoV Coronavirus Neutralizing Antibody Rapid Test Immunochromatography BfArm

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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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2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Logo Interpretation

Intended Use


The kit is used for qualitative detection of novel coronavirus (2019-nCoV) neutralizing antibody in human serum, plasma and whole blood samples.
Novel coronavirus (2019-nCoV) is a new coronavirus belonging to β genus. It can cause viral pneumonia, with fever, fatigue and dry cough as the main clinical manifestations, and a few patients with nasal congestion, runny nose, sore throat and diarrhea. In severe cases, dyspnea and/or hypoxemia occurred one week later. In severe cases, acute respiratory distress syndrome, septic shock, metabolic acidosis which is difficult to correct, bleeding and coagulation dysfunction, etc.
Novel coronavirus has several structural proteins, including spikes (S), envelopes (E), membranes (M) and nucleocapsids (N). The 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 interacts strongly with human ACE2 receptor, which leads to endocytosis of host cells in lung and virus replication.
After 2019-nCoV infection or vaccination, it will trigger an immune response and produce antibodies in the blood. Secreted antibodies can prevent virus infection, they will exist in the infected human circulatory system for several months to several years, and they will quickly and firmly combine with pathogens, thus preventing virus replication. These antibodies are called neutralizing antibodies. The detection of neutralizing antibody can judge whether people have the ability to prevent virus infection.

Principle of Detection


The kit adopts immunochromatography. The test card includes 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 loading end. The S-RBD containing the marker in the binding pad binds with the ACE2 protein immobilized on the NC membrane, and the signal can be detected at the position of T line. If there is neutralizing antibody in the sample, it will combine with the labeled S-RBD antigen when it flows through the labeled pad. Neutralizing antibody can prevent the combination of S-RBD and ACE2, thus causing the signal value to decrease. 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 will not develop color. No matter whether the T line is colored or not, the control line R and the quality control line C should be colored. The quality control line C is used for quality control. If the color of the line C is not developed, it means that the test is invalid, and the sample must be retested.

Main Components


The kit consists of a detection card and a sample buffer solution.
Test card: It consists of aluminum foil bag, desiccant, test paper strip and plastic card. The test strip consists of absorbent paper, nitrocellulose membrane, sample pad, bonding pad and rubber plate. T line (detection line) of nitrocellulose membrane is coated with ACE2 protein, C line (quality control line) is coated with quality control line antibody, R line (control line) is coated with control antibody, and the binding pad contains 2019-nCOV antigen labeled by marker.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


Keep it at 2℃ ~ 30℃ for 12 months.
The validity period of the aluminum foil bag is 1h after unpacking.
Batch number of products: see label for details.
Expiry date of products: see label for details.

Sample Requirements


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

Test Method


Read the instruction manual carefully before testing. Please restore all reagents to room temperature before testing, and the testing should be carried out at room temperature.
1. Take out the test card from the packaged reagent bag and use it within 1 hour.
2. Drop 20μL sample (serum, plasma or whole blood) into the sample adding hole of the test card, then drop 2 drops (about 60μL) of sample buffer, and start timing.
3. Read the results when reacting for 10 ~ 15 minutes at room temperature. The reading result is invalid after 20 minutes.

Interpretation of Test Results


Figure for judging test card results:
1. Invalid result: there is no reaction line in the quality control line (C line), and the test is invalid, so the experiment should be repeated.
2. Negative result: the detection line (T line) appears red band, and the color development is higher than or equal to that of the control line (R line), and the quality control line (C line) and the control line (R line) develop color.
3. Positive results: there is no red band in the detection line (T line) or red band in the detection line (T line), but the color development is lower than that of the control line (R line), and the quality control line (C line) and the control line (R line).

Limitation of Test Method


1.This kit is a qualitative test, and is only used for auxiliary diagnosis in vitro.
2. Please make sure that an appropriate amount of samples are added for testing. Too much or too little sample 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 of the disease should be made after comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators


1. Analysis of specificity
1.1 Cross-reaction: The interference of the following types of antibodies was evaluated with reagents, and the results 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 Interfering substances: The following substances were added to the samples with specified concentrations, and their potential interference in the neutralization antibody test project of novel coronavirus (2019-nCoV) was evaluated. The results show that various interfering substances will not interfere with the detection results of this 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 novel coronavirus (2019-nCoV)IgG antibody detection reagent (colloidal gold method) as the contrast reagent, 120 positive samples and 300 negative samples were selected for detection respectively, and 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 after use.

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

4. Avoid the harsh environment (such as the environment containing high-concentration corrosive gases and dust such as 84 disinfectant, sodium hypochlorite, acid, alkali or acetaldehyde). Laboratory disinfection should be carried out after 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 when discarded.

6. Please use the reagent within the validity period marked on the outer packaging, and use the test card as soon as possible after taking it out of the aluminum 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 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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