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2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card

Henan Lantian Medical Supplies Co.,Ltd.

2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card

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 Test Kit For Standard Q Test Kit

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 Test Kit For Standard Q Test Kit

Intended Use


This kit is for qualitative testing of 2019 ncov neutralization
Antibodies in human serum, plasma and whole blood samples
The 2019 type ncov is a new type β Cov. It can cause viral pneumonia, and the main clinical symptoms are fever, lethargy, and dry cough. Some patients have symptoms such as stuffy nose, runny nose, sore throat, and diarrhea. Severe patients usually develop respiratory distress and / or hypoxemia after 1 week, and severe patients rapidly develop acute respiratory distress syndrome, infectious shock, refractory metabolic acidosis, coagulopathy, etc. Proceed.
2019 ncov has several structural proteins such as spinodon, envelope, envelope, etc.
(m) Nuclear capsid protein (n). Among them, the spike protein contains one receptor binding domain (RBD) and is involved in the recognition of angiotensin converting enzyme 2 (ACE2) on the cell surface receptor. The 2019 ncov peplomer RBD was found to interact strongly with the human ACE2 receptor, causing intracellular receptor and viral replication in the lung host.
In 2019, NV infection and vaccination will cause an immune response, and antibodies will be produced in the blood. Antibody secretion prevents viral infections. Once infected, it remains in the circulatory system for months to years and binds to pathogens quickly and safely to prevent viral replication. These antibodies are called neutralizing antibodies. Neutralizing antibody tests determine whether a person can prevent a viral infection.

Principle of Detection


This element is immunochromatography The test card includes quality control line C, detection line T and control line R. The test sample (serum / plasma / whole blood) diffuses upward through the capillary phenomenon after the sample is completed. The s-rbd contains a binding pad marker that couples with the ACE2 protein immobilized on the NC membrane and detects the signal at the T-line position. If a neutralizing antibody is present in the sample, the s-rbd antigen on the label is bound by the marker pad. Neutralizing antibodies can interfere with the binding of s-rbd to ACE2 and reduce signal values. The T-ray signal value has a negative correlation with the content of neutralizing antibody. If the neutralizing antibody concentration is high enough, the T line will not change color. Regardless of the color of the T line, the control line R and the horizontal control line C are in color. Quality control line C is used for quality control. If the c-line does not have a color display, the test is invalid and the sample must be retested.

Main Components


The kit consists of a test card and sample buffer.
Test card: Aluminum foil bag, desiccant, test sheet, plastic card. It consists of an absorbent, a nitrocellulose membrane, a sample pad, a lining, and a rubber plate. The T line (detection line) of the nitrocellulose membrane is coated with the ACE2 protein, the C line (quality control line) is coated with the quality control antibody, and the R line is coated with a large antibody. The group sheet is coated with the 2019 ncov antigen.
Sample buffer: Phosphoric acid, sodium azide

Storage Conditions and Validity


Spend 12 months at 2-30 degrees Celsius
Aluminum foil is valid for 1 hour after opening.
Placement number: See label for more information.
Deadline: See label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. Precipitates and suspended matter in the sample affect the experimental results and must be removed by centrifugation.
3. Use of anticoagulants: jellyfish skin, EDTA, sodium citrate Anticoagulants have little effect.
4. Blood collection should be done by a medical professional. Priority is given to serum / plasma tests. In emergencies and special cases, a patient's whole blood sample can be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature should not exceed 8 hours. 2 ° C-8 ° Can be stored at ° C for 6 months and 5 days, but do not overwhelm the freeze-thaw cycle. All blood samples should be frozen at 48 ° C to 8 ° C.

Test Method


Please read the instructions carefully before the test. Bring all reagents to room temperature before testing. The inspection is performed at room temperature.

1. Remove the test card from the packaged reagent bag and use it within 1 hour.
2. Test well loading Well μ add L (serum, plasma or whole blood) sample, μ add sample buffer and start timing.
3. The result will be invalidated after 20 minutes.

Interpretation of Test Results


2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card

Interpretation of test card
1. Invalid result: The quality control line (C line) is invalid. There is no reaction line and it will need to be retested.
2. Negative result: A red band appears on the test line (t line), and the color development performance is the standard line (r line), quality control line (C line), and reference line (r line).
3. Positive result: No red band appears on the test line (t line). The red band on the test line (t line) is color coded based on the reference line (r line) and quality control line (C line), and is color coded based on the reference line (r line).

Limitation of Test Method


This device is used only for in vitro diagnostics.
2. If there are too many or too small samples, the result will be false.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be affected as they can affect test results.
4. Reagent test results are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. The final diagnosis of this disease should be based on a comprehensive assessment 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: The new coronavirus (2019 ncov) neutralizing antibody test item evaluates the potential interference of the following substances by adding the following substances to a sample of a specific concentration. As a result, it was clarified that each interfering substance did not interfere with the detection result 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 and 300% negative samples selected from Novell Coronavirus (2019 nCoV) IgG detection reagent (colloidal gold method) as controls. The results can be summarized as follows.

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum

Positive Negative

2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card

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 used only for in vitro diagnosis.
2.It cannot be used after processing.
3. Before you start, read the operating guidelines carefully and follow the reagent guidelines.
4. Disinfectant, corrosive gas such as sodium hypochlorite, alkali acid, acetaldehyde, poor environment. After the experiment is over, the laboratory needs to be disinfected.
5. All samples and reagents used are potentially contagious and must be disposed of in accordance with local regulations.
6. Reagents must be used within the shelf life indicated on the package. Use the guide card as soon as possible and remove it from the aluminum foil bag to prevent moisture.

Company profile


2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card
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.


Product Tags:

Whole Blood Neutralizing Antibody rapid Test

      

2019-NCoV Coronavirus Neutralizing Antibody Test

      

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