2019 nCoV Neutralization Technology Qualitative Test Kit
Antibodies in human serum, plasma and whole blood samples
The 2019-nCOV is a new machine, the β-COV. Viral pneumonia can be caused and the main clinical symptoms are fever, lethargy and dry cough. Many patients complain of stuffy nose, runny nose, sore throat, and diarrhea. Severely ill patients usually develop dyspnea and / or hypoxemia after one week, and severely ill patients rapidly progress to acute respiratory distress syndrome, infectious shock, refractory metabolic acidosis, and coagulopathy.
NCoV in 2019 has several structural proteins such as spinoprotrusion proteins, enveloped proteins, enveloped proteins, etc.
(m) Contact with the nucleus (n). The Peak protein contains one receptor binding domain (RBD) and recognizes angiotensin converting enzyme 2 (ACE2) on the cell surface receptor. In 2019, it was revealed that the spike protein RBD in nCoV strongly interacts with the human ACE2 receptor, causing intracellular reception and viral replication in the lung host.
2019-n Cobalt virus infection or vaccination provokes an immune response and produces antibodies in the blood. This antibody prevents viral infection. Once infected, it remains in the circulatory system for months to years and rapidly and tightly binds to pathogens to prevent viral replication. These antibodies are called neutralizing antibodies. Neutralizing antibody tests determine whether a person can prevent a viral infection.

Principle of Detection

This kit uses immunochromatography. The test card contains quality control line C, test line T and reference line R. The sample (serum / blood / whole blood) diffuses onto the loading well by capillarity. The binding pad maker s-rbd binds to the ACE2 protein immobilized on the NC membrane and detects the signal at the T-line position. If the neutralizing antibody is present in the sample, the neutralizing antibody binds to the labeled s-rbd antigen as it flows through the labeled pad. Neutralizing antibodies block the binding of s-rbd to ACE2, causing a decrease in signal values. The T-ray signal value has a negative correlation with the content of neutralizing antibody. If the antibody concentration is high enough in the middle, there is no color in the T line. The reference line r and the quality control line c must be colored regardless of whether the t line is colored or not. Quality control line c is used for quality control. If there is no color display on line C, the test is invalid and the sample must be retested.

Main Components

The kit consists of a test card and sample buffer.
Test card: Consists of aluminum foil bag, desiccant, test sheet and plastic card. The test sheet consists of water-absorbent paper, nitrocellulose membrane, sample pad, adhesive pad, and rubber plate. The nitrocellulose membrane is coated with ACE2 protein on the T line (test line), Ab on the C line (quality control line), and standard Ab on the R line (reference line), and the label 2019 nCoVAb is affixed to the adhesive plate.
Sample buffer: Phosphate, sodium azide, etc.

Storage Conditions and Validity

Keep at 2 ° C to 30 ° C and the effective period is 12 months.
The aluminum foil bag is valid for 1 hour.
Lot No .: See label for details.
Validity period: See label.

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the sample may affect the experimental results and should be removed by centrifugation.
3. Anticoagulant: Heparin, EDTA, sodium citrate are ineffective.
4. Venipuncture is performed by a professional medical staff. We recommend that you give priority to serum / plasma tests. In emergencies and special cases, a patient's entire blood sample can also be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature should not exceed 8 hours. They are
It can be stored at 2 ° C to 8 ° C for 5 days and below -20 ° C for 6 months, but avoid repeated freeze-thaw cycles. Whole blood samples should not be stored frozen at 2 ° C-8 ° C within 48 hours.

Test Method

Please read the instructions carefully before testing. Allow all reagents to cool to room temperature before testing. The test is conducted at room temperature.
1. Remove the test card from the packaged reagent bag and use it within 1 hour.
2. Add 20 μL of sample (whole serum and plasma), add 2 drops of sample buffer (about 60 μL), and start the clock.
3. After reacting at room temperature for 10 to 15 minutes, read the results. After 20 minutes, the result was invalid.

Interpretation of Test Results

Figure to judge the result of the test card:
1. Invalid result: Quality control line (c line) has no reaction line, is invalid and needs to be retested.
2. Negative result: A red band appears on the test line (T line) and the color is higher than or equal to the reference line (R line), and the color is on the quality control line (C line) and the reference line (R line). arrive.
3. Positive result: The test line (T line) has no red band and is smaller than the reference line (R line), and the control line (C line) and reference line (R line) are colored.

Limitation of Test Method

1. This kit is used for qualitative tests and is used only for in-vitro assisted diagnosis.
2. Make sure to add the appropriate amount of sample and perform the test. If the sample size is too large or too small, the results may be incorrect.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be avoided as they can affect test results.
4. The test results of this reagent are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. The final diagnosis should be a combination of evaluation and laboratory results from all clinical trials.

Product Performance Indicators

1. Analysis of specificity
1.1 1.1 Cross-reactivity: As a result of evaluating the following types of antibody interfering reagents, there was no cross-reactivity.

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: The following substances are added to the sample at specific concentrations to assess potential interference in the 2019 nCoV and Ab test items. As a result, none of the interfering substances interfered with the detection 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: Using the above 2019 NCOVIGAB detection reagent (colloidal gold method) as a comparative reagent, 120 positive samples and 300 negative samples are selected and tested. The research results can be 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 used only for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Read the instructions carefully before starting work and perform the experimental work according to the reagent instructions.
4. Avoid inspections under harsh environmental conditions (including 84 disinfectants, sodium hypochlorite, alkali or acetaldehyde, high concentration corrosive gases such as dust). After the experiment is over, disinfect the laboratory.
5. All samples and reagents used are considered potential contagious substances and should be disposed of in accordance with local laws and regulations.
6. Reagents should be used within the shelf life indicated on the package. Use a test card as soon as you remove it from the aluminum foil bag to prevent moisture.

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

COVID-19 Neutralizing Antibody Rapid Test Standard Q 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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