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ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test
ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test
ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test
ZOSBIO Whole Blood 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
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) Product Performance Indicators

Intended Use

The kit is used for qualitative detection of 2019 NCOV neutralization
Antibodies in human serum, plasma and whole blood samples
As a new type, 2019 NCOV is a kind of NCOV. The main clinical symptoms of viral pneumonia are fever, fatigue and dry cough. Some patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. In severe cases, dyspnea or hypoxemia occurred one week later, and acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulation disorder occurred rapidly in severe cases.
There are several structural proteins in 2019 NCoV, including spike, envelope protein and membrane protein
(m) and nuclear cosid(n). Among them, spy protein contains receptor binding domain (RBD), which is involved in identifying angiotensin converting enzyme 2(ACE 2) on cell surface receptor. It is found that the peak rbd in 2019 ncov interacts strongly with human aceh 2 receptor, which leads to host cell endocytosis and virus replication in lung.
2019 NCoV infection or preventive vaccination will trigger an immune response and produce antibodies in the blood stream. Secreted antibodies can prevent virus infection. They exist in human circulation several months to several years after infection, and they are rapidly combined with pathogens in order to prevent virus replication. These antibodies are called neutralizing antibodies. Neutralizing antibody detection can determine whether people have the ability to resist virus infection.

Principle of Detection

There are quality control line c, test line t and reference line r on the test card of immune tomography used by KKit. the test sample (serum/plasma/whole blood) diffuses upward through capillary action in the filling hole. the S-RBD on the pad is combined with ACE 2 protein fixed on NC membrane, and the signal can be detected at the test line position. If you neutralize the antibody in the sample, it will flow through the labeled pad and bind with the labeled S-RBD antigen. Neutralizing antibody prevents S-RBD from binding to ACE 2, and reduces the signal value. The signal value of T line is negatively correlated with the concentration of neutralizing antibody, and it does not develop color when the concentration of neutralizing antibody is high enough. T-line colorizes t-line. The quality control line is used for quality control. If there is no color display in line C, the test is invalid and the sample should be re-inspected.

Main Components

The kit consists of a test card and a sample buffer.
Test card: It consists of aluminum foil package, desiccant, test strip and plastic card. The test paper consists of absorbent paper, cellulose nitrate film, sample pad, bonding pad and rubber plate. T-line (test line) of cellulose nitrate film is covered with bonding pad containing ACE 2 protein, C-line (QC-line), AB, R-line (reference-line), reference AB and marking 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 unsealing period of aluminum foil packaging is effective for 1 hour.
Lot number: see label.
Deadline: see detailed label

Sample Requirements

1. collected serum, plasma or whole blood samples.
2. Sediments and suspended solids in samples will affect the experimental results and must be removed by centrifugal separation.
Anticoagulant therapy: heparin, EDTA and sodium citrate are not important.
3. Blood collection shall be conducted by professional medical personnel. Serum/plasma testing is recommended. Patients' whole blood samples can also be used for rapid detection under emergency or special circumstances.
Serum and plasma samples shall not be stored for more than 8 hours at room temperature. They're right there
It can be stored at 2-8 C, 5 days C and 6 months C, but repeated freeze-thaw cycles must be avoided. Whole blood samples are not frozen and must be kept at 2℃ ~ 8℃ for more than 48 hours.

Test Method

Please read the instructions carefully before testing. All reagents were restored to room temperature at room temperature.
1.Remove the test card from the packaging kit within one hour.
2.Add l sample (serum, plasma or whole blood) to the loading well, then add 2 drops (about 60 drops) to the μ test card, start the μ sample buffering, and start the timing.
3. The results were obtained after 10 ~ 15 minutes of reaction at room temperature, but the results were invalid after 20 minutes.

Interpretation of Test Results

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

Test card result judgment chart
1. invalid result: the quality control line (c) is invalid and needs to be re-tested.
2. Negative results: the color of red stripe appears above or above the test line (T line), baseline (R line), quality control line (C line) and baseline line (R line).
3.Positive result: red band on test line (t), or the following red band on test line (t), instead of reference line (r), mass control line (c) and reference line (r).

Limitation of Test Method

1. The kit is not only used for qualitative detection, but also for auxiliary diagnosis in vitro.
2. Add a proper amount of samples in advance for testing. Too many or too small samples may lead to inaccurate results.
3.Hemolysis, blood lipid, jaundice and contaminated samples may affect the test results, so avoid these samples.
4.It should not be the only basis for clinical trials and treatments. The final diagnosis of the disease should be carried out after comprehensive evaluation of all clinical and experimental 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 the 2019 NCoV and AB test plan, the following concentrations were added to the samples to evaluate their potential interference. The results show that various interfering substances will not interfere with the detection results of reagents.

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 were selected when the commercial 2020 ncov igg ab test reagent (colloidal gold method) was used as control reagent. The results are summarized as follows.

2019-nCoV IgG Ab detection reagent (colloidal goldmethod)

Sum
Positive Negative

ZOSBIO Whole Blood 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 only used for in vitro diagnosis.
2. This product is disposable and cannot be recycled.
3. In strict accordance with the reagent instructions before surgery, and experiment.
4. Avoid conducting experiments under harsh environmental conditions (environment containing 84 kinds of disinfectants, sodium hypochlorite, corrosive gases and dust with high concentration such as acid, alkalinity and acetaldehyde). Disinfect after the experiment.
5. Samples and reagents used are regarded as potentially infectious substances and treated according to local regulations.
6. Reagents shall be used within the validity period of outsourcing label. To prevent moisture, the test card must be removed from the aluminum foil bag and used as soon as possible.

Logo interpretation

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

 Do not re-use

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

 Store at 2℃～30℃

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

 Consult instructions for use

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

In vitro diagnostic medical

device

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

 Batch code

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

 Use-by date
ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test Keep dry

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

 Keep away from sunlight

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

Authorized representative in the

European Community

ZOSBIO Whole Blood 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

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen TestZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen TestZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen TestZOSBIO Whole Blood 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.

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ZOSBIO Whole Blood 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
MOQ :
To be negotiated
Price :
To be negotiated
Contact Supplier
ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test
ZOSBIO Whole Blood 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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