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COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography
COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography
COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography
COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography
Specifications
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
Description

(COVID-19) Neutralizing Antibody Rapid Test (Immunochromatography) Interpretation Of Test Results

Intended Use

The kit is used for the qualitative detection of neutralization in 2019-nCoV
Antibodies in human serum, plasma, and whole blood samples.
The 2019-nCOV, as a new type, is a type of nCOV. Can cause viral pneumonia, the main clinical manifestations are fever, fatigue, dry cough. A few patients are accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. critically ill cases usually develop respiratory difficulties and / or hypoxemia a week later, and severe cases rapidly develop into acute respiratory distress syndrome, septic shock, difficult to correct metabolic acidosis, and coagulation dysfunction.
There are several structural proteins in 2019-nCoV, including spikes, envelope proteins, and membrane proteins
(M) and the Nuclear Cosid (N). Among them, the spiking protein contains a receptor-binding domain (RBD) responsible for identifying the angiotensin-converting enzyme 2 (ACE2) on the cell surface receptors. It was found that RBD of spikes in 2019-nCoV interacts strongly with the human ACE2 receptor, in turn leads to endocytosis and viral replication of host cells in the lung.
2019-An nCoV infection or vaccination will trigger an immune response that produces antibodies in the bloodstream. Antibodies secreted can prevent virus infection. They exist in human circulation for months to years after infection and quickly and firmly bind them to the pathogen to prevent virus replication. These antibodies are called neutralizing antibodies. Neutralizing antibody tests can determine whether a person has the ability to prevent viral infection.

Principle of Detection

Kkit use immunotomography. The test card contains the quality control line C, test line T and the reference line r, sample to test (serum / plasma / whole blood) spread upward through capillary action at the loading hole, combining the S-RBD in the pad to the fixed ACE2 protein on the NC film, and the signal can be detected at the test line position. If neutralizing antibodies in the sample, it binds to the labeled S-RBD antigen as it flows through the marker pad. Neutralizing antibodies prevent S-RBD from binding to ACE2, resulting in decreasing signal values, the T line signal values negatively correlated with neutralizing antibody content, and no color when the neutralization antibody concentration is high enough. For the T line, the T line are colored. Quality control line are used for quality control. If there is no color display on the C line, the test is not valid and the sample must be retested.

Main Components

The kit consists of test cards and a sample buffer.
Test card: composed of aluminum foil package, desiccant, test strip and plastic card. Among them, the test paper consists of water absorption paper, cellulose nitrate film, sample pad, binding pad and rubber plate. The cellulose nitrate membrane T line (test line) is coated with ACE2 protein, C line (QC line) with Ab,R line (reference line) with reference Ab, binding pad containing mark-mark 2019-nCoV Ab.
Sample buffer: phosphate, sodium nitride, etc.

Storage Conditions and Validity

Hold at 2 ℃ ~ 30 ℃ and valid is set to 12 months.

The unpacking period of the aluminum foil package is valid for one hour.

Batch number: See the label for details.
Deadline: See the label for details

Sample Requirements

1. collected serum, plasma, or whole blood samples.
The sediment and suspended objects in the 2. samples may affect the experimental results and should be removed by centrifugation.
3. anticoagulation: heparin and EDTA, sodium citrate are not significant.
4. blood collection shall be conducted by professional medical personnel. Sera / plasma testing is recommended. Whole blood samples of patients can also be used for rapid detection in emergency or special situations.
The 5. serum and plasma samples should not be stored at room temperature for more than 8 hours. They are out there
It can be stored from 2 to 8 ℃ for 5 days and 6 months below-20 ℃, but repeated freeze-thaw cycles should be avoided. Whole blood samples shall not be frozen and shall be kept at 2 ℃ ~8 ℃ for no more than 48 hours.

Test Method

Read the instructions carefully before testing. Return all reagents to room temperature at room temperature.
1.The removes the test card from the packaged kit for use within one hour.
2. adds 20 μL samples (serum, plasma or whole blood) to the loading hole of the test card, then adds 2 drops (approximately 60 μL) sample buffer and begins timing.
3. The results were read after 10-15 minutes of reaction at room temperature. Invalid results after 20 minutes.

Interpretation of Test Results

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

Figure for judging test card results:

1.Invalid result: quality control line (C) is not reactive and should be retest.
2. negative result: a red strip appears in the test line (T line), color color above or equal to baseline line (R line), quality control line (C line) and baseline line (R line) coloring.
3. positive results: no red band on the test line (T), or less red band on the test line (T) than reference line (R), mass control line (C) and reference line (R).

Limitation of Test Method

1. The kit is used for qualitative detection and only for in vitro assisted diagnosis.
2. ensures that an appropriate amount of samples is added for testing. Too much or too small the sample size can cause inaccurate results.
3. hemolytic, lipid blood, jaundice and contaminated samples may affect the test results and these samples should be avoided.
4. The test results of this reagent are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

​

1. Analysis of specificity

1.1 Cross reaction: evaluate the interference of the following type of antibody to the reagent and show 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 substances: In 2019-nCoV and in the Ab test program, add the following concentration to the sample to assess its potential interference. The results show that the various interfering substances do not disturb 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 study: When the marketed 2019-nCoV IgG Ab test reagent (colloidal gold method) was used as the control reagent, 120 positive samples and 300 negative samples were selected for testing. The results are summarized as follows:

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum
Positive Negative

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 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 for in vitro diagnosis only.
2. This product is disposable and cannot be recycled.
3. carefully before operation and conduct experimental operation strictly according to the reagent instructions.
4. avoids experiments in harsh environmental conditions (environments containing 84 disinfectant, sodium hypochlorite, high concentrations of corrosive gases such as acid, alkali, or acetaldehyde, and dust). Laboratory disinfection shall be performed after the experiment.
All 5. samples and used reagents shall be considered potentially infectious substances and treated in accordance with local regulations.
6. reagents shall be used within the period of validity indicated on the outer package. The test card shall be used as soon as possible after removal from the aluminum foil bag to prevent moisture.

Logo interpretation

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 Do not re-use

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 Store at 2℃～30℃

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 Consult instructions for use

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

In vitro diagnostic medical

device

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 Batch code

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 Use-by date
COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography Keep dry

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 Keep away from sunlight

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

Authorized representative in the

European Community

COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

 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

COVID-19 Neutralizing Ag Rapid Test Kit ImmunochromatographyCOVID-19 Neutralizing Ag Rapid Test Kit ImmunochromatographyCOVID-19 Neutralizing Ag Rapid Test Kit ImmunochromatographyCOVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography
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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COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

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Product Detail
Brand Name :
ZOSBIO
Model Number :
2019-NCoV Neutralizing Antibody
Certification :
CE BfArm
Place of Origin :
Henan
MOQ :
To be negotiated
Price :
To be negotiated
Contact Supplier
COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography
COVID-19 Neutralizing Ag Rapid Test Kit Immunochromatography

Henan Lantian Medical Supplies Co.,Ltd.

Active Member
4 Years
henan, zhengzhou
Since 2016
Business Type :
Manufacturer, Exporter, Seller
Main Products :
Ag Rapid Test Kit, COVID-19 Test Kit, Coronavirus Neutralizing Antibody Rapid Test
Employee Number :
500~1000
Certification Level :
Active Member
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