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ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

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Henan Lantian Medical Supplies Co.,Ltd.

City: zhengzhou

Province/State:henan

Country/Region:china

Tel:86-180-37878230

Contact Person:
Mr.chen View Contact Details

ZOSBIO Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test

Brand Name	ZOSBIO
Model Number	2019-NCoV Neutralizing Antibody
Certification	CE BfArm
Place of Origin	Henan
Minimum Order Quantity	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

Detailed Product 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

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
	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

	Do not re-use		Store at 2℃～30℃
	Consult instructions for use		In vitro diagnostic medical device
	Batch code		Use-by date
	Keep dry		Keep away from sunlight
	Authorized representative in the European Community		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

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 Ag Rapid Test Kit Whole Blood colloidal gold antigen test ZOSBIO Ag Rapid Test Kit

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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

(COVID-19) Neutralizing Antibody Rapid Test (Immunochromatography) Product Performance Indicators

Intended Use

Principle of Detection

Main Components

Storage Conditions and Validity

Sample Requirements

Test Method

Interpretation of Test Results

Limitation of Test Method

Product Performance Indicators

Precautions

Logo interpretation

Basic Information

Company profile

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