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BetaCoronavirus Sars-Cov-2 Neutralization Antibody Test Immunochromatography

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Henan Lantian Medical Supplies Co.,Ltd.

BetaCoronavirus Sars-Cov-2 Neutralization Antibody Test Immunochromatography

Country/Region	china
City & Province	zhengzhou henan
Categories	Dyestuff Intermediates

Product Details

2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography)

Intended Use

The kit is used for the qualitative detection of 2019-nCoV neutralizing Ab in human serum,plasma, and whole blood samples.

As a new type, 2019-nCOV is a kind of β-COVs. It can cause viral pneumonia, with main clinical manifestations of fever, fatigue and dry cough. A few patients are accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases often develop

dyspnea and/or hypoxemia after a week, and those at serious condition rapidly progress to acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, and coagulation dysfunction

Principle of Detection

The kit uses immunochromatography. The test card contains quality control line C, test line T and reference line R. The sample to be tested (serum/ plasma/ whole blood) diffuses upwards by capillary action at the loading well, and S-RBD of the maker in the binding pad binds to the immobilized ACE2 protein on the NC membrane, and the signal can be detected at the position of T line. If there is neutralizing antibody in the sample, it will bind to the labeled S-RBD antigen when flowing through the labeling pad. The neutralizing antibody can prevent the binding of S-RBD toACE2,resulting in a decrease in the signal value, and the T-line signal value is negatively correlated with the neutralizing antibody content, and when the neutralizing antibody concentration is high enough, there is no color on the T-line. The reference line R and quality control line C should be colored regardless of whether T line is colored or not. Quality control line C is used foruality control. If there is no color display on C line, the test is invalid and the sample must bere-tested

Main Components

The kit consists of a test card and sample buffer

Test card: It is composed of aluminum foil bag, desiccant, test strip and plastic card. Among them, the test strip is composed of absorbent paper, nitrocellulose membrane, sample pad,binding pad and rubber sheet. The nitrocellulose membrane T line (test line) is coated

with ACE2 protein, the C line (quality control line) is coated with Ab on quality control line, the R line (reference line) is coated with reference Ab, and the binding pad contains marker-labeled 2019-nCoV Ab.

Sample buffer: Phosphate, sodium azide, etc.

Storage Conditions and Validity

Keep it at 2℃ ~ 30℃, and the validity period is set at 12 months.

The validity period is an hour for aluminum foil bag being unpacked.

Batch No. : See label for details.

Expiration date: See label for details

Sample Requirements

1.Collect serum, plasma or whole blood samples.

2.The sediment and suspended matter in the sample may affect the experimental results, andshould be removed by centrifugation.

3. Anticoagulant: Heparin, EDTA and sodium citrate anticoagulant have no significant effect.

4. Blood collection should be performed by professional medical personnel. It is recommended to give priority to serum/plasma test. In emergency or special circumstances, the patient's whole blood sample can also be used for rapid test.

5. Serum and plasma samples should not be stored at room temperature for more than 8h. They can be stored for 5 days at 2℃ to 8℃ and for 6 months below -20℃, but repeated freeze-thaw cycles should be avoided. Whole blood samples should not be frozen and it should be stored at 2℃～8℃ for no more than 48h

Test Method

Read the instructions carefully before testing. Please return all reagents to room temperature before testing, and the test should be performed at room temperature.

1.Take out the test card from the packaged reagent bag and use it within an hour.

2.Add 20μL of sample (serum, plasma or whole blood) to the loading well of the test card, then add 2 drops (about 60μL) of sample buffer and then start timing.

3. Read the result when reacting at room temperature for 10-15 minutes. The result is invalid after 20 minutes

Interpretation of Test Results

Interpretation of test card:

Invalid result: It is invalid with no reaction line on the quality control line (C line), and the test should be carried out again.
Negative result: A red band appears on the test line (T line), and the color rendering is higher than or equal to the reference line (R line), and the quality control line (C line) and reference line (R line) are colored.
Positive result: No red band appears on the test line (T line), or the red band on the test line (T line) is less coloring than the reference line (R line), and the quality control line (C line) and the reference line (R Line) are colored.

Limitation of Test Method

This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
Make sure to add an appropriate amount of sample for test. Too much or too little sample volume may result in inaccurate results.
Hemolysis, lipemia, jaundice and contaminated samples may affect the test results, and these samples should be avoided.
The test results of this reagent are for clinical reference 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

1.1Cross reaction: The following types of antibodies were evaluated for interference with reagents, and the results showed 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

1.2Interfering substances: The following concentrations of substances were added to the samples at the specified concentrations to evaluate their potential interference in 2019-nCoV neutralization Ab test project. The results showed that all kinds of interfering substances did not interfere with the test 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 study: Using the marketed 2019-nCoV IgG Ab detection reagent (colloidal gold method) as a comparison reagent, 120 positive samples and 300 negative samples were selected for testing. The results are summarized as follows:

		2019-nCoV IgG Ab detection reagent (colloidal gold method)		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

This product is only used for in vitro diagnosis.
This product is disposable, which cannot be recycled and reused.
Read the instructions carefully before operation, and carry out the experimental operation in strict accordance with the reagent instructions.
Avoid conducting experiments in bad environmental conditions (the environments containing 84 disinfectant, sodium hypochlorite, high-concentration corrosive gases such as acid and alkali or acetaldehyde, and dust). Laboratory disinfection should be carried out after the experiment.
All samples and used reagents should be regarded as potentially infectious substances and disposed of in accordance with local regulations.
Reagents should be used within the validity period marked on the outer package. The test card should be used as soon as possible after being taken out of 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

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.