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2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test
2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test
Specifications
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 Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test
Composition :
Detection card, sample buffer
Storage conditions :
2℃～30℃
term of validity :
12 months
Sample requirements :
Serum, plasma or whole blood
Description

2019 NCOV Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

Intended Use

This kit is for qualitative testing of 2019 NCOV neutralization
Antibodies in human serum, plasma and whole blood samples
The 2019 NCOV is the new NCOV. The main clinical symptoms of viral pneumonia are fever, fatigue and dry cough. Some patients complain of stuffy nose, runny nose, sore throat, and diarrhea. Dyspnea or hypoxemia develops after 1 week in severely ill patients, and acute respiratory distress syndrome, infectious shock, metabolic acidosis, and coagulation disorders develop rapidly in severely ill patients.
2019 NCoV contains several structural proteins including spinosaurus, envelope, envelope
(m) and nuclear cosid (n). Of these, the spy protein contains a receptor binding domain (RBD) that is involved in the identification of angiotensin converting enzyme 2 (ACE 2) on the cell surface receptor. It was revealed that the rbd peak of ncov in 2019 strongly interacts with the human aceh2 receptor, causing intracellular receptor in the host and viral replication in the lung.
NCoV infection or vaccination in 2019 provokes an immune response and produces antibodies in the blood. Virus infection can be prevented by secreting an antibody. They are present in the human circulation months to years after infection and rapidly bind to pathogens to prevent viral replication. These antibodies are called neutralizing antibodies. Neutralizing antibody tests determine whether a person is capable of resisting a viral infection.

Principle of Detection

The immunochromatography test card used by KKit has a quality control line c, a detection line t, and a reference line r. The sample (serum / plasma / whole blood) is raised by capillarity in the filling hole. The ACE 2 protein immobilized on the NC membrane binds to the s-rbd on the pad, and the signal can be detected at the position of the test line. Neutralizing the antibody in the sample flows through the labeled pad and binds to the labeled s-rbd antigen. Neutralizing antibodies interfere with the binding of s-rbd to ACE 2 and reduce signal values. The T-ray signal value has a negative correlation with the neutralizing antibody concentration, and the T-line does not develop color when the intermediate antibody concentration is sufficiently high. T line Color the T line. The quality control line is used for quality control. If there is no color display on line C, the test is invalid and the sample is re-examined.

Main Components

The kit consists of a test card and sample buffer.
Test card: Consists of aluminum foil packaging, desiccant, test sheet, plastic card. The test paper consists of a water-absorbent paper, a cellulose nitrate film, a test piece pad, an adhesive pad, and a rubber plate. The T line (test line) of the cellulose nitrate membrane is covered with an adhesive pad containing the ACE 2 protein, C line (QC line), AB line, R line (reference line), reference AB and NCOV AB marks.
Sample buffer: Phosphate, sodium nitride, etc.

Storage Conditions and Validity

Keep at 2 ° C~30 ° C and set the validity period to 12 months.
The opening period of the aluminum foil pack is 1 hour.
Lot number: Look at the label.
Deadline: See detail label

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the sample affect the experimental results and must be removed by centrifugation.
Anticoagulant therapy Heparin, EDTA, sodium citrate are not important.
3. Blood collection is performed by a professional medical staff. Serum / plasma tests are recommended. The patient's entire blood sample can also be used for rapid testing in emergencies and special cases.
The storage time of serum and plasma samples at room temperature should not exceed 8 hours. They are there
It can be stored at 2-8 degrees Celsius, 5 days Celsius, and 6 months Celsius, but repeated freeze-thaw cycles should be avoided. Whole blood samples should not be frozen and should be stored at 2 ° C-8 ° C for at least 48 hours.

Test Method

Please read the instructions carefully before testing. Bring all reagents to room temperature.
1. Remove the test card from the packaging kit within an hour.
2. Add l sample (serum, plasma or whole blood) to the load hole, add 2 drops (about 60 drops) to the μ test card, start buffering the μ sample, and start time counting.
3. It reacts at room temperature for 10 to 15 minutes and gives a result, but after 20 minutes, no result is obtained.

Interpretation of Test Results

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

Test card result judgment sheet
1. Invalid result: Quality control line (c) is invalid and needs to be retested.
2. Negative result: Red stripes appear above or above the detection line (T line), baseline (R line), quality control line (C line) and baseline (R line).
3. Positive result: The red band on the test line (t), or the following red band on the test line (t), instead of the reference line (r), quality control line (c) and reference line (r).

Limitation of Test Method

1. The kit can be used not only for qualitative tests but also for in-vitro assisted diagnosis.
2. Put an appropriate amount of sample in advance and inspect. Results may be inaccurate if there are too many or too small samples.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be avoided as they can affect test results.
4. It should not be the sole basis for clinical trials and treatment. The final diagnosis of this disease should be made by comprehensively assessing the results of all clinical and experimental studies.

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 Interfering substances: In the 2019 NCoV and AB test plans, the following concentrations will be added to the sample to assess potential interference. As a result, it was found 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 samples and 300 negative samples are selected using a commercially available 2020 ncov igg antibody detection reagent (colloidal gold method) as a control reagent. The results can be summarized as follows.

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum
Positive Negative

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 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. This product is a disposable product and cannot be collected.
3. Strictly follow the reagent instructions before surgery to perform the experiment.
4. Avoid experiments in harsh environmental conditions (84 disinfectants, sodium hypochlorite, environments containing corrosive gas and high concentrations of dust, such as acids, alkalis, acetaldehyde). Disinfect after the experiment.
5. Samples and reagents used are considered potential contagious substances and are treated according to local regulations.
6. Reagents should be used within the validity period of the outsourced label. The test card must be removed from the aluminum foil bag and used as soon as possible to prevent moisture.

Logo interpretation

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 Do not re-use

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 Store at 2℃～30℃

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 Consult instructions for use

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

In vitro diagnostic medical

device

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 Batch code

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 Use-by date
2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test Keep dry

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 Keep away from sunlight

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

Authorized representative in the

European Community

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

 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

2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test
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

calcium test kit

,

kit prova alcol test

,

p24 antigen test
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2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

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Product Detail
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
Contact Supplier
2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

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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