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CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019

Henan Lantian Medical Supplies Co.,Ltd.

CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019

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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 : 12 months

Sample requirements : Serum, plasma or whole blood

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2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Sample Requirements

Intended Use


The sensor is used to detect the neutralizing antibody of new coronavirus (2019 ncov) in human serum, plasma and whole blood samples.

New corona virus (2019-ncov) β It belongs to a new type of 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. In severe cases, they will be rapidly developed due to acute dyspnea syndrome, septic shock, maladaptive metabolic acidosis and hemorrhagic dysfunction.

The novel coronavirus has many structural proteins such as spike (s), exoderm (E), membrane (m) and nucleotide (n). Spindles include receptor binding domains (RBDS) that recognize the cell surface. Receptor angiotensin converting enzyme 2 (ACE 2). We found that the 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, and in order to prevent virus replication, they will quickly and closely bind 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, test line T and control line R. The sample to be tested (serum / plasma / whole blood) diffuses upward by capillary action after the end of the sample. S-rbd, including the labeling on the binding pad, is bound 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, s-rbd antigen on the label is combined by labeling pad. Neutralization antibody can prevent s-rbd from binding with ACE2 and reduce signal value. The signal value of T-line is 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 level management line C shall be colored regardless of color of T-line or not. Quality management line C is used for quality management. If line C does not have a color display, the test is not valid, the sample needs to be retested.

Main Components


The kit consists of test card and sample buffer.
Test card: composed of aluminum foil bag, desiccant, test strip and plastic card. The test stripe consists of absorbent, nitrocellulose film, sample pad, liner and rubber plate. The T-line (test 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 dazhaoqun. 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: please refer to the label for details.
Due date: please refer to the label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. The sediment and floating matter of the sample will affect the experimental results and should be removed by centrifugation.
3. Anticoagulant: the use of jellyfish skin, EDTA and sodium citrate anticoagulant has little effect.
4. Blood collection needs medical experts to complete. Serum / plasma test is preferred. In case of emergency or special circumstances, whole blood samples of patients can be used for rapid examination.
5. Serum and plasma samples should not be stored at room temperature for more than 8 hours. It can be stored for 6 months at 2 ℃ ~ 8 ℃ for 5 days and below - 20 ℃, but repeated freezing thawing cycles should be avoided. The whole blood samples should not be frozen at 2 ℃ ~ 8 ℃ for less than 48 hours.

Test Method


Please read the guide carefully before the test. Please reduce all the test drugs to room temperature before testing. The test should be carried out at room temperature.
1. Take out the test card from the packaged test bag and use it within 1 hour.
2. 20 μ L add the sample (serum, plasma or whole blood) to the filling hole of the test card, and then drop 2 drops (about 60 drops) μ l) Add sample buffer and start timing.
3. React at room temperature for 10 ~ 15 minutes and read the results. The results were invalid after 20 minutes.

Interpretation of Test Results


CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019

Test card result judgment chart:
1. Invalid results: there is no response line in the quality management line (line C), the test is invalid, and the experiment needs to be carried out again.
2. Negative results: the test line (line T) appears red band, and the color rendering is higher than the control line (line R), quality management line (line C) and control line (line R).
3. Positive results: the test line (line T) has no red band, or the test line (line T) has red band, but the color rendering is lower than the control line (line R), and the quality is decreased. Control line (line C) and control line (line R).

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 samples. Too many or too few samples can lead to incorrect results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect the test results and should be avoided.
4. The test results of the reagent are only for clinical reference and can not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease must be carried out after 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.

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: in the new coronavirus (2019 ncov) neutralizing antibody test project, the potential interference of the following substances was evaluated by adding the following substances to the specific concentration samples. The results showed that all kinds of 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: 120 positive samples and 300 negative samples were selected from Novell coronavirus (2019 ncov) IgG test reagent (colloidal gold method) as contrast agent. The results are summarized as follows.

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum

Positive Negative

CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019

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 reused after use.
3. Please read the operation guide carefully before starting, and carry out the experiment according to the reagent guide.
4. Do not carry out experiments in harsh environment (such as 84 disinfectant, sodium hypochlorite, acid-base or acetaldehyde and other corrosive gases and dusty environment). The laboratory should be disinfected after the experiment.
5. All samples and reagents used should be considered as potential infectious substances and destroyed according to local regulations.
6. The reagent must be used within the validity period marked on the external package. The sensor card should be used as soon as possible after it is removed from the aluminum foil bag to prevent moisture.

Company profile


CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019CE BfArm Covid Vaccine Neutralizing Antibody Test For Coronavirus Disease 2019
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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