2019-nCoV Ag Rapid Test (Immunochromatography) Precautions

Intended Use

The kit is used for qualitative detection of 2019-n coronavirus antibody collected from human nasal swab samples.
As a new product, 2019-nCOV is a kind of β-COVs. Can cause viral pneumonia, the main clinical manifestations are fever, fatigue and dry cough. A few patients have symptoms such as nasal congestion, runny nose, sore throat and diarrhea. Critical patients often suffer from dyspnea and/or hypoxemia after one week, and severe patients will rapidly develop into acute respiratory distress syndrome, septic shock, refractory metabolic acidosis and coagulation dysfunction.
This product uses lateral flow immunoassay to qualitatively detect 2019-n coronavirus antibody in nasal swabs of suspected patients. In the acute stage of infection, antigens are usually detected in nasal swab samples. The positive results indicate the presence of viral antigen, but the clinical correlation between the patient's medical history and other diagnostic information is also a necessary condition to determine the infection status. Positive results can not rule out bacterial infection or simultaneous infection with other viruses.
This kit is for laymen to use at home in non-laboratory environment (such as personal home or some non-traditional places, such as offices, sports events, airports, schools, etc.). The test results of this kit are for clinical reference only. It is suggested that the patient's condition should be comprehensively analyzed according to the clinical manifestations and other laboratory tests.

Principle of Detection

This kit is an immunoassay method based on the principle of double antibody sandwich technology. As an indicator mark, the 2019nCoV monoclonal antibody with marker was sprayed on the binding pad. In the detection process, the 2019-nCoV antibody in the sample was combined with the labeled 2019-nCoV monoclonal antibody to form an Ag- antibody complex. The complex migrates upward on the membrane by capillary effect until it is captured by another 2019-n coronavirus monoclonal antibody pre-coated on the test line, forming a sandwich complex. If there is 2019-nCoVAg in the sample, a red band will appear in the T area of the explanation window. Otherwise, it will be a negative result. Control line (c) is used for program control. If the test process is executed correctly, it should always be displayed.

Main Components

The kit consists of a test card, sample buffer and swab.
Test card: It consists of aluminum foil bag, desiccant, test strip and plastic card. The test strip consists of absorbent paper, nitrocellulose membrane, sample pad, adhesive pad and rubber sheet. T line (test line) of nitrocellulose membrane is coated with 2019nCOV antibody, and C line (quality control line) is coated with goat anti-mouse polyclonal antibody, and the binding pad contains labeled 2019nCOV antibody.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity

Keep it at 2℃~30℃, and the validity period is tentatively set at 18 months.

The validity period of aluminum foil bags is 1 hour.

Production batch number: see the label for details.

Expiry date: see the relevant contents of the label for details.

Sample Requirements

(1) nasal swab collection method: insert the sampling swab into the nostril, and the tip of the swab should be inserted 2.5cm away from the edge of the nostril. Roll the swab along the mucous membrane in the nostril five times, and then repeat this process with the same swab for the other nostril. (See Figure 1 for details)

Figure 1 Collection method for nasal swab

(2) Sample treatment: the collected samples should be treated with the sample buffer provided by this kit as soon as possible (if it can't be treated immediately, the samples should be stored in a dry, sterilized and tightly sealed container), stored at 2℃~8℃ for no more than 24 hours, and stored at -70℃ for a long time (but avoid repeated freezing and thawing).

Test Method

Please read the relevant instructions carefully before testing. Please return all reagents to room temperature before testing, and test at room temperature.
1. Sample treatment (see Figure 2)
1. Insert the sampled swab into the sample buffer and rotate it around the inner wall for about 10 times to make the sample dissolve in the solution as much as possible.
2. Squeeze the tip of the swab along the inner wall of the tube to keep the liquid flowing into the tube as much as possible, and remove and discard the swab.
3. Cover the dryer.

Figure 2 Sample processing

Figure 3 Detection procedure

2. Test procedure (see Figure 3)

1. take out the test card.

2. Add 2 drops (about 80μ50) to extract the processed sample into the test card loading well, and then start the timer.

3. Read the results after 15 minutes at room temperature. After 20 minutes, the result is invalid

Interpretation of Test Results

Interpretation of test card (Figure 4):
① Invalid result: there is no reaction line on the quality control line (line C), which is invalid and should be tested again.
② Negative result: the quality control line (line C), a red band, is colored.
③ Positive results: Two red bands, the test line (T line) and the quality control line (C line) are colored.

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative detection, only for auxiliary diagnosis in vitro.
2. This product is suitable for nasal swab samples. Other sample types may have inaccurate or invalid results.
3. Please make sure to add an appropriate number of samples for testing. Too many or too few samples may lead to inaccurate results.
4. The test results of this reagent are for clinical reference only, and should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

1. detection limit: inactivated SARS-CoV-2 virus culture was used in this study, and the minimum detection limit of the kit was 6×102TCID50/mL.
2. Test with the company's reference products, and the results should meet the requirements of the company's reference products.
2.1 coincidence rate of positive reference products: the positive reference products P1-P5 of the company are all positive.
2.2 The coincidence rate of negative reference materials: the negative reference materials N1-N10 of enterprises are all negative.
2.3 test limit: the lowest test limit reference product L1-L3 of the enterprise is detected, L1 should be negative, L2 and L3 should be positive.
2.4 Repeatability: the repeated reference products J1 and J2 of enterprises were detected, and the results of each detection were 10 times positive.
3. Cross-reaction: Add the following concentrations of microorganisms and viruses to the sample at the specified concentration to evaluate their potential interference in the 2019-nCoVAg detection project. The results showed that there was no cross reaction and no interference from various microorganisms and viruses.

4. Interference substances: In 2019, the following concentrations of drugs were added to the samples with specified concentrations to evaluate their potential interference in nCoVAg detection items. The results showed that all kinds of drugs did not interfere with the detection results of this reagent.

5. Hook effect: After inactivated 2019-nCoV culture, no hook effect was observed in the detection range of 1.0×106TCID50/mL with high concentration.
6. Clinical study: RT-PCR reagent was used as contrast agent to evaluate nasal swab samples. 120 positive samples and 120 negative samples (RT-PCR detection) were selected for detection with Zhongxiu detection reagent. The research results are summarized as follows:

Nasal swab		RT-PCR		Sum
		Positive	Negative
	Positive	116	2	118
	Negative	4	118	122
Sum		120	120	240
Sensitivity		96.67%, (95%CI: 91.74%～98.70%)
Specificity		98.33%, (95%CI: 94.13%～99.54%)

Precautions

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1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be reused.
3. Read the operating instructions carefully before operation, and conduct experimental operation in strict accordance with the reagent operating instructions.
4. Avoid conducting experiments under harsh environmental conditions (including 84 kinds of disinfectants, sodium hypochlorite, acid and alkali, acetaldehyde and other high-concentration corrosive gases and dust). After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be regarded as potentially infectious substances and treated according to local regulations.
6. Reagent should be used within the validity period indicated on the outer package. It should be used as soon as possible after being taken out of the aluminum foil bag to prevent moisture.

Logo interpretation

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

Basic Information

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	ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA Tel:+86-371-55016575 Email:zosbio@zosbio.com
	SUNGO Europe B.V. Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

Company profile

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Zhongxiu Technology Co., Ltd. is a high-tech enterprise specializing in the research, development, production and management of in vitro diagnostic products. In vitro diagnostic products developed by the company include POCT series, microbial series, biochemical series, immune series reagents and supporting instruments.
The company always adheres to the core concept of "speed, accuracy and life", and is committed to providing high-quality products and services for the society and contributing to human health.

Zhongxiu Science And Technology Co.,Ltd., founded in 2016, is located in Dingluan Industrial Zone, Changyuan City, Henan Province. The company covers an area of about 100 acres and the initial investment is about 200 million yuan. The company has a scientific and complete management system, a purification workshop of national standards, and a fully functional inspection center. On this basis, the company will continue to invest in research and development, accumulate technical strength, update manufacturing equipment, improve production technology, improve inspection technology, improve product quality, and provide customers with safe and effective in vitro diagnostic products.

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, immune series, microbial series and other 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.