The kit was used to determine the quality of antibodies and antibodies in human serum, plasma, and whole blood.
Novel crown virus is a new type of corona virus which belongs to the genus Beta. can cause viral pneumonia, the main clinical manifestations are fever, fatigue, dry cough, few patients have a stuffy nose, sore throat, diarrhea. In severe cases, there are respiratory problems and low levels or hypoxia after one week. Severe cases include acute respiratory distress syndrome, septic shock, metabolic acidosis that is difficult to correct, bleeding and coagulation disorders.
The new type of corona virus has various structural proteins: crest protein, E protein, membrane protein, and nuclear protein. Receptor-associated proteins bind domains responsible for identifying receptors on the cell surface. The results revealed a strong interaction between RBD's 2019 ncv spike protein and the human ACE2 receptor that engulfs host cells and pulmonary viruses.
After 2019 years of infection or vaccination, it triggers an immune reaction and produces antibodies in the blood. It secretes anti-viral antibodies that are present in the circulating system of the infected human body for months or years and are rapidly and closely linked to pathogens to protect against viruses. These antibodies are known as neutralizing antibodies. Neutralizing antibodies can check whether people have the ability to protect against viral infections.

Principle of Detection

used test kit immunochromatography The test card consists of a C, T-line, and R test quality control lines. The entire blood sample control line is measured by capillary action at the s-rbd load end. Binding to proteins marked on the NC film and signal can be detected in T line position. If neutralizing antibodies present in the sample are bound to the s-rbd marker, antigens flowing through the pad neutralizing markers can block the combination of s-rbd and ACE2 and reduce the signal value. negatively correlated with the content of antibodies. When the antibody concentration is high enough, the line is not colored, line R and quality line C will be colored whether the T line is colored or not, quality line C is used for quality control. correct and the sample must be tested again.

Main Components

The kit includes a test card and a sample buffer solution.
The test card consists of a dry aluminum foil bag, a test strip, and a blister card. The test strip consisted of nitrocellulose absorbent paper, sample film, adhesive sheet and rubber sheet. The T line was coated with ACE2 protein, the C line was coated with antibody, the R line was coated with a control antibody, and the 2019 ncv antigen was marked.
For example, phosphate buffer, sodium oxide, etc.

Storage Conditions and Validity

It is stored for months at temperature.
The shelf life of the aluminum foil bag is one hour after opening the box.
See the product label for more details.
Product expiration date, see label for more details.

Sample Requirements

Water, serum, plasma, or a whole blood sample will be collected.
The sludge and suspended solids in the sample can affect the results obtained from the experiment and should be removed by centrifugal force.
Effects of Heparin, EDTA and Sodium Citrate
The water will be collected by professional medical personnel. It pointed out that the detection of plasma levels should be a special consideration. In an emergency or special situation, a patient's entire blood sample can also be used for a quick examination.
Serum and plasma samples should not be stored at room temperature for more than eight hours, but you should keep them for the next five days. All blood samples must not exceed 48 hours cryogenic freezing.

Test Method

Read the instructions carefully before testing. Please recall all chemicals at room temperature before testing and test at room temperature.

Take the test card from the bag packaging and use it within an hour.
The whole serum or plasma or whole blood sample is dripped into the hole of the test card and then dripped to approximately 60μL sample buffer start time.
weight at room temperature and read the result Read the result incorrectly after twenty minutes.

Interpretation of Test Results

Figure for judging test card results:
1. Incorrect result, no reaction on line C, test is invalid and should be repeated.
2. Negative result, line T shows a red bar greater than or equal to control line C and line R.
3. Positive results: The T-line or T-line does not have a red band, but its color appears lower than the control line C and the control line.

Limitation of Test Method

1.This kit is a qualitative test and is only used for in vitro diagnostic support.
2. Make sure that the correct number of samples is added for testing. Too large or too small a sample may lead to inaccurate results.
3. Hemolysis, lipidemia, jaundice, and contaminated specimens may affect test results, so avoid these specimens.
4. Test results for this reagent are for clinical use 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: Interference with the following types of antibodies was assessed with the reagents and the results showed that there was 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: The following substances were added to the samples at specific concentrations and assessed for their potential interference with the design of the novel coronavirus neutralizing antibody test (2019-nCoV). The results show that different interfering substances will not interfere with the detection results of this 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 studies: Using the new Coronavirus (2019-nCoV) IgG Antibody Detection Reagent (colloidal gold method) as contrast reagent, 120 positive and 300 negative samples were selected for detection, respectively, and the results were 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 for in vitro diagnostic use only.
2. This product is disposable and cannot be recycled after use.
3. Before the operation, carefully read the instruction manual and perform the experimental operation in accordance with the reagent instruction manual.
4. Avoid harsh environments (such as environments containing high concentration corrosive gases and dust, such as disinfectant, sodium hypochlorite, acid, alkali, or acetaldehyde). After the experiment is completed, laboratory disinfection should be performed.
5. All specimens and used reagents should be handled as potentially infectious and should be disposed of in accordance with local regulations in case of rejection.
6. Please use the reagent within the expiry date marked on the outer carton, and use the test card as soon as possible after removing 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

2019 NCoV Coronavirus Neutralizing Antibody Rapid Test Immunochromatography Adopts

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: