2019-NCoV Ag Rapid Test (Immunochromatography) Usage Manual For Self-Test Test Method

Intended Use

The kit is used for qualitative detection of ncov-Ag collected from human nasal swab samples in 2019.

As a new weapon, ncov in 2019 is a new weapon β-Joe. It can cause viral pneumonia, and its main clinical manifestations are fever, fatigue and dry cough. A few patients suffer from nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critically ill patients usually develop dyspnea and/or hypoxemia after one week. In severe cases, it can rapidly develop into acute respiratory distress syndrome, septic shock, refractory metabolic acidosis and coagulation disorder.

The 2019 ncovag strains in nasal swabs of suspicious patients were detected by lateral flow immunoassay. In the acute stage of infection, antigens are usually detected in nasal swab samples. A positive result indicates the existence of virus antigen, but the clinical correlation between the patient's medical history and other diagnostic information is also a necessary condition for determining the infection status. Positive results cannot rule out bacterial infection or co-infection with other viruses.

This toolbox is used by laymen in non-laboratory environment (such as personal residence or some non-traditional places, such as offices, sports activities, airports, schools, etc.). The test results of this kit are for clinical reference only. It is suggested to make comprehensive analysis according to clinical manifestations and other laboratory tests.

Principle of Detection

The kit is an immunoassay kit based on the principle of double antibody sandwich technology. The 2019 ncov monoclonal antibody labeled with markers was sprayed on the binding pad as an indicator. In the test process, the 2019ncov-Ag in the sample combined with the labeled 2019ncov monoclonal antibody to form an Ag-AB complex. The complex migrated upward by capillary effect until it was captured by another 2019 ncov monoclonal antibody, forming a sandwich complex. If 2019 ncov-Ag exists in the sample, a red band will appear in the T area of the interpretation window. Otherwise, it will be a negative result. A control line (c) is used for program control. If the test program is executed correctly, it should always be displayed.

Main Components

The kit consists of a test card, a sample buffer and a 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 was coated with 2019nCOVAb, C-line (quality control line) was coated with goat anti-mouse polyclonal Ab, and 2019nCOVAb was attached to the pad.

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 insert the tip of the swab 2.5cm away from the edge of the nostril. Roll the swab along the mucosa in the nostril five times, and then repeat the process with the same swab (see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample treatment: the collected samples should be treated with the sample buffer provided by this box as soon as possible (if they can't be treated immediately, they should be stored in dry, sterilized and sealed containers), and stored at -70℃ within 2 hours (but avoid repeated freezing and thawing)

Test Method

Please read the instructions carefully before testing. Please return all reagents to room temperature before testing. The test should be carried out at room temperature.

1. sample processing flow (see fig. 2)

1. Insert the sampling swab into the sample buffer and rotate it close to 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 make the liquid flow into the tube as much as possible, and take out 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

Test card description (figure 4):
① invalid result: the quality control line (line c) is invalid without response line, and should be tested again.
② Negative line result: the quality control line (line C) is red ribbon.
③ Positive results: The two red bands, test line (T line) and quality control line (C line) are all 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. Results of other sample types may be inaccurate or invalid.
3. Please make sure to add an appropriate number of samples for testing. Excessive or small sample size 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 can only be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

1. detection limit: in this study, inactivated SARS-CoV-2 virus was used for culture, and the minimum detection limit of the kit was 6×102TCID50/mL.
2. Use the company reference products for testing, and the results should meet the requirements of the company reference products.
2.1 pass rate of positive control products: P1-P5 of positive control products of the company are all positive.
2.2 pass rate of negative control products: N1-N10 of the company's negative control products are all negative.
2.3 detection limit: the minimum detection limit reference products L1-L3 are detected, L1 is negative, L2 and L3 are positive.
2.4 Reproducibility: The reference materials J1 and J2 were reused by the test company, and each test was positive 10 times.
3. Cross-reaction: Add the following microorganisms and viruses to the samples at the specified concentration to evaluate their potential interference to the nCoVAg test items in 2019. The results showed that there was no cross reaction and interference from various microorganisms and viruses.

4. Interference substances: In 2019 nCoV-Ag test project, the following concentrations of drugs were added to samples to evaluate their potential interference. The results showed that all kinds of drugs did not interfere with the detection results of reagents.

5. Hook effect: In the high concentration range of 1.0, ×106TCID50/mL, 2019nCoV inactivated culture was not observed.
6. Clinical research: Using RT-PCR detection reagent as contrast agent to evaluate nasal swab specimens. Choose 120 positive and 120 negative (RT-PCR detection), and use Zhongxiu reagent for detection. 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 recycled.
3. Read the instructions carefully before operation, and carry out experimental operation in strict accordance with the reagent instructions.
4. Avoid harsh environmental conditions (including 84 disinfectants, sodium hypochlorite, acid and alkali or acetaldehyde, and other high-concentration corrosive gases and dust, etc.). After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be regarded as potentially infectious materials and treated according to local laws and regulations.
6. The reagent should be used within the validity period indicated on the outer packaging. After taking it out of the aluminum foil bag, use the test card as soon as possible 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 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.

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.