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New Coronavirus Neutralizing Antibody Rapid Test For Serum Plasma

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New Coronavirus Neutralizing Antibody Rapid Test For Serum Plasma

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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 : twelve months

Sample requirements : Serum, plasma or whole blood

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2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Precautions


Intended Use


This kit is used to qualify the normal coronavirus (2019 ncov) neutralizing antibody in human serum, plasma and whole blood samples.
New coronavirus (2019 ncov) is a novel coronavirus β Coronavirus belongs to genus. It causes viral pneumonia, and is mainly caused by fever, sorrow, and cough, and there are not many patients with symptoms such as nasal congestion, DDT, sore throat, diarrhea. Severe respiratory distress syndrome, septic shock, metabolic acidosis, and coagulation disorder are progressed.
The novel coronavirus has several structural proteins, including stab (s), envelope (E), membrane (m), and nuclear capsid (n). The receptor binding domain (RBD) has tyrosine receptor 2 (acs2). In the present study, it was clarified that the tyrosine RBD of 2019 ncov strongly interacts with the ACE 2 receptor of the human body, and it causes the endocytosis of the host cell in the lung and replication of the virus.
2019 ncov infection and vaccination can result in an immune response, and antibodies can be made in the blood. The secreted antibody prevents viral infection and exists in the circulating system of the body for several months to several months after infection, and quickly binds with the pathogen to prevent the replication of the virus. These antibodies are called neutralizing antibodies. Detecting neutralizing antibodies can determine whether the ability to prevent viral infections is provided.

Principle of Detection



This kit uses immunochromatography. The inspection card contains a quality control line C, an inspection line T, and an inspection line R, and the sample to be examined (serum / plasma / whole blood) diffuses upward by the capillary action at the edge end. S-rbd, which contains markers in the binding pad, associates with the ACE2 protein immobilized in the NC membrane to detect the signal at the T line position. When neutralizing antibody is present in the sample, it is combined with the s-rbd antigen labeled in the marker pad. Neutralizing antibody inhibits s-rbd and ACE 2 binding, and signal values decrease. There was a negative correlation between the neutralizing antibody content and the signal value of the T line. The control line R and the quality control line C should be colored regardless of the color of the T line. Quality control line C is used for quality control, but if the C line has no color, the test is disabled, so the sample must be retested.

Main Components


The kit consists of a test card and a sample buffer.
Test card: aluminum foil bag, desiccant, tester sheet, plastic card. Of these, the sheet is composed of a water absorbing paper, a cellulose hydroxide film, a sample pad, a bonding pad, and an adhesive plate. There is an ACE 2 protein in the scaffold of the cellulose succinate membrane, the quality control line antibody is connected to the c-line (quality control line), and the contrast line is combined with the control line, and it is combined with the 2019 ncov antigen marked by the marker.
Sample buffer solution: phosphate, sodium azide

Storage Conditions and Validity


Save at 2 to 30 degrees Celsius, and the effective period is 12 months.
The aluminum foil bag is opened and the effective period is 1H.
Product lot number: see the label for details.
Product invalid date: see the label for details.

Sample Requirements


1 serum, plasma or whole blood samples.
Since precipitates and floatings in the sample may affect the experimental results, centrifugation must be removed.
Anticoagulants using anticoagulant heparin, EDTA and sodium citrate were not effective.
4. It is recommended that a professional medical staff should do so and prioritize serum / plasma examination. In case of an emergency or a special case, the patient's whole blood sample can also be used for quick inspection.
5.Serum and plasma samples can not exceed 8h at room temperature, can be stored at 5 to 8 degrees Celsius for 5 days, and can be kept at - 20 degrees Celsius for 6 months to avoid repeated freezing and thawing. The whole blood sample should not be frozen, and should not be stored above 48 h at 2 to 8 ° C.

Test Method


Please read the usage instructions before the test. Return all reagents to room temperature before the test. Test should be done at room temperature.
1. Take out the test card from the packed reagent bag and use it within 1 hour.
2.Sample (serum, plasma or whole blood) 20 μ 2 drops of sample buffer solution μ L).
3. Reading after 20 minutes is invalid.


Interpretation of Test Results



Explanation of the test card

1.An invalid result: the quality control line (C line) reaction line appears, the detection is invalid, and the retest should be done.
2.Negative result: the red band appears in the inspection line (t line), and the color is higher than the control line (r line), and the quality control line (C line) and the control line (r line) color.
3.Positive result: the red band does not appear in the inspection line (t line), and the red band appears in the inspection line (t line), but the color is lower than the control line (r line), and the quality control line (C line) and the control line (r line) color.

Limitation of Test Method



1.This kit is a qualitative test and is used only for in vitro diagnosis.
2. If the number of samples is too small or too small, the result may be inaccurate.
3. Hemolysis, lipidemia, jaundice, contamination samples should be avoided because it may affect the test results.
4. The results of this reagent are only provided for clinical reference and should not be the only basis for clinical practice, and the final diagnosis should be performed after overall evaluation of all clinical and laboratory results.

Product Performance Indicators


1. Specificity analysis

1.1Cross reaction: no interference was observed when the interference was tested for the following types of antibodies.


SNItemCross reactionSNItemCross reaction
1Endemic human coronavirus OC43No10EnterovirusNo
2Endemic human coronavirus HKUINo11EB virusNo
3Endemic human coronavirus NL63No12Measles virusNo
4Endemic human coronavirus 229ENo13Human cytomegalovirusNo
5Influenza A virusNo14RotavirusNo
6Influenza B virusNo15NorovirusNo
7Respiratory syncytial virusNo16Mumps virusNo
8AdenovirusNo17Varicella-zoster virusNo
9RhinovirusNo18Mycoplasma pneumoniaeNo

1.2 In order to evaluate the possibility of interferers, the following concentrations were added to the specified concentration samples. As a result, it was shown that various interferences did not interfere with the detection result of this reagent.


Interfering substancesConcentrationInterfering substancesConcentration
Bilirubin≤50mg/dLTriglycerides≤15mmol/mL
Hemoglobin≤5g/LCholesterol L≤500mg/d
Rheumatoid factor≤500IU/mLHuman total IgG≤14mg/mL
Ribavirin0.4mg/mLFluticasone0.5mg/mL
Oxymetazoline10mg/mLDexamethasone5 mg/mL
Histamine hydrochloride10mg/mLTriamcinolone acetonide5mg /mL
Tobramycin1mg/mLLevofloxacin0.2 mg/mL
Oseltamivir1mg/mLAzithromycin0.1 mg/mL
Zanamivir1mg/mLCeftriaxone0.4 mg/mL
Arbidol0.5mg/mLMeropenem0.2 mg/mL

2.Clinical study: a novel test of the normal coronavirus (2019-ncov) IgG antibody test reagent (colloidal gold method) was carried out as a comparative reagent, and 120 positive and 300 samples were tested


2019-nCoV IgG Ab detection reagent (colloidal goldmethod)


Sum

PositiveNegative

Positive1155120
Negtive5295300
Sum120300420
Sensitivity95.83%, (95%CI: 90.62%~98.21%)
Specificity98.33%, (95%CI: 96.16%~99.29%)

Precautions


1.This product is for in vitro diagnosis.
2. This product is disposable, and cannot be used again.
3.
Avoid disseminated environments such as 84 disinfectants, sodium hypochlorite, acid alkaloids, acetaldehyde, and so on.
5. All samples and Empress's reagents are regarded as potential infectious substances and must be treated according to the local laws when disposing.
6.The reagent should be used within the effective period of the display of packaging. Use the soap card from the aluminum foil bag as soon as possible and prevent moisture.

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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