The kit is used for the qualitative detection of neutralizing antibodies to novel coronavirus (2019-nCoV) in human serum, plasma, and whole blood samples.
Novel coronavirus (2019-nCoV) is a novel coronavirus belonging to the coronavirus of the genus β. Can cause viral pneumonia, the clinical manifestations are mainly fever, fatigue, dry cough, a few patients with nasal congestion, runny nose, sore throat and diarrhea and other symptoms. In severe cases, dyspnea and / or hypoxemia occur a week later, with the rapid progress of acute respiratory distress syndrome, sepsis shock, difficult to correct metabolic acidosis and blood clotting dysfunction.
Novel coronavirus has several structural proteins, including S (s), envelope (E), membrane (M), and nuclear capsid (N). Among them, spinin contains a receptor binding domain (RBD) responsible for identifying cell surface receptor angiotensin convertase 2 (ACE2). It was found that the 2019-nCoV spike protein RBD interacts strongly with the human ACE2 receptor, in turn leading to endocytosis and viral replication of the host cells within the lung.
A 2019-nCoV infection or vaccination triggers an immune response that produces antibodies in the blood. Secresecreted antibodies prevent virus infection, which exist in human circulating systems for months to years and quickly bind firmly to pathogens to prevent replication of the virus, with antibodies called neutralizing antibodies. The detection of neutralizing antibodies can determine whether people have the ability to prevent virus infection.

Principle of Detection

The kit uses immunotomography. The test card contains the quality control line C, test line C, and the control line R, to test sample (serum / plasma / whole blood) at the sample end from the capillary action upward, binding the marker S-RBD to the NC membrane fixation ACE2 protein, the signal can be detected at the T-line position. If neutralizing antibodies are present in the sample, binding to the labeled S-RBD antigen when flowing through the marker pad, the neutralization antibody prevents the binding of S-RBD and ACE2, causing a reduced signal value, the T signal value is negatively associated with the neutralizing antibody content and the neutral antibody concentration is high enough. Whether line T is color or not, the control line R and mass control line C. QC C is used for quality control, if no C color means the test is invalid, the sample must be retested.

Main Components

The kit consists of a test card and a sample buffer.
Test card: composed of aluminum foil bag, desiccant, test paper and plastic card. The test paper is composed of water absorbing paper, cellulose nitrate film, sample pad, binding pad and plywood. The cellulose nitrate membrane T line (detection line) package has ACE2 protein, C line (QC line) package is mass control line antibody, and R line (control line) package has control antibody containing 2019-nCOV antigen on the binding pad.
Sample buffer: phosphate, sodium nitride, etc.

Storage Conditions and Validity

2 ℃ ~30 ℃ Save, valid for 12 months.
Effective for 1h. after removing the aluminum foil bag
Product lot number: see the label for details.
Product failure date: see the label for details.

Sample Requirements

1. collected serum, plasma, or whole blood samples.
The sediment and suspended objects in the 2. samples may affect the experimental results and should be centrifuged.
3. Anticoagulant: No significant effect on using heparin, EDTA, and sodium citrate anticoagulant.
4. blood collection should be carried out by professional medical staff with preferred serum / plasma testing and whole blood samples available for rapid testing in emergency or special situations.
5. serum and plasma samples can be stored at room temperature beyond 8h,2 ℃ ~8 ℃ for 5 days, and under-20 ℃ for 6 months but to avoid repeated freezing and thawing. Whole blood samples shall not be frozen and shall not exceed 48 h. under 2 ℃ ~8 ℃

Test Method

1.Invalid result: quality control line (C line) no reaction line, invalid detection, should be retested.
2. negative results: red band appears in test line (line T), and color show above or equal to control line (R line), mass control line (line C line) and control line (line R) show color.
3. positive results: no red band in test line (T line) or red band in test line (T line), but the color display was lower than control line (R line), mass control line (C line) and control line (R line).

Interpretation of Test Results

1.This kit is qualitative detection and is only used for in vitro assisted diagnosis.
2. Make sure a proper sample is added for testing. Too much or too small a sample size can cause inaccurate results.
3. hemolysis, hyperlipidemia, jaundice and contaminated samples may affect the test results and these samples should be avoided.
4. The test results of this reagent are only for clinical reference only and shall not be used as the sole basis for clinical diagnosis and treatment. The final disease diagnosis should be made after comprehensive evaluation of all clinical and laboratory results.

Limitation of Test Method

1. This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
2. Make sure you add the right amount of samples for testing. Too many or too few samples may result in inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect test results and should be avoided.
4. The test results of this reagent are only for clinical reference 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: The following types of antibodies were assessed 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

1.2 Interference substances: The following concentrations were added in the specified concentration sample to assess their potential interference in the novel coronavirus (2019-nCoV) and in the antibody test program. The results showed that the various interfering substances do not disturb the test results 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. 2. clinical study: Listed Novel Coronavirus (2019-nCoV) IgG antibody detection reagent (colloidal gold method) was used as the comparative reagent, and 120 positive samples and 300 negative samples were selected respectively. 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 used for in vitro diagnosis only.
2. This product is a disposable product, non-recyclable.
3. carefully before operation and conduct experimental operation in strict accordance with the reagent instructions.
4. avoids experiments in harsh conditions (such as high concentration of corrosive gases and dust containing 84 disinfectant, sodium hypochlorite, acid-alkali or acetaldehyde), and laboratory disinfection shall be conducted after the end of the experiment.
All samples of 5. and used reagents shall be considered potentially infectious and discarded in accordance with local regulations.
The 6. reagent should be used within the validity period of the outer packaging label. The test card should be used as soon as possible after being removed from the aluminum foil bag to prevent moisture exposure.

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

CE Coronavirus Neutralizing Antibody Rapid Test Detection Card Sample Buffer

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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