2019-NCoV Ag Rapid Test (Immunochromatography) Usage Manual For Self-Test Storage Conditions And Validity

Intended Use

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

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

The lateral flow immunoassay was used to qualitatively detect the 2019 strain of ncovag in nasal swabs from suspected patients. In the acute phase of infection, the antigen is usually detected in a nasal swab sample. A positive result indicates the presence of viral antigens, but the clinical relevance of the patient's medical history and other diagnostic information is also a necessary condition for determining the infection status. A positive result cannot exclude bacterial infection or co-infection with other viruses.

This toolbox is for laymen to use in non-laboratory environments (such as personal residences 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 recommended to comprehensively analyze the patient's condition based on 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 the marker was sprayed on the binding pad as an indicator marker. During the test, the 2019 ncov-Ag in the sample combined with the labeled 2019 ncov monoclonal antibody to form an Ag-AB complex. The complex migrates upward through the capillary effect until it is captured by another 2019 ncov monoclonal antibody pre-coated on the test line to form a sandwich complex. If there is 2019 ncov-Ag in the sample, a red band will appear in the T area of the explanation window. Otherwise, it will be a negative result. The 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, sample buffer and swab.

Test card: consists 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 2019 nCOV Ab, the C line (quality control line) is coated with goat anti-mouse polyclonal Ab, and the binding pad is labeled with 2019 nCOV Ab.

Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity

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

The validity period of the aluminum foil bag out of the box is one hour.

Production batch number: see label for details.

Validity period: see 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 5 times, then repeat the process with the same swab for the other nostril ((see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample processing: The collected samples should be processed as soon as possible with the sample buffer provided by this kit (if they cannot be processed immediately, they should be stored in a dry, sterilized, sealed container), and stored within 2 hours for no more than 24 hours ℃ ～8℃, keep it at -70℃ (but avoid repeated freezing and thawing)

Test Method

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

1. Sample processing (see Figure 2)

1. Insert the sampling swab into the sample buffer and rotate it about 10 times close to the inner wall 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, remove and discard the swab.

3. Cover the dripper.

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 to the loading well of the test card, and then start the timer.

3. Read the result after 15 minutes at room temperature. The result is invalid after 20 minutes.

Interpretation of Test Results

Test card explanation (Figure 4):
① Invalid result: the quality control line (line C) has no response line is invalid and should be tested again.
② Negative result: The quality control line (line C) is a red ribbon.
③ Positive result: the two red bands, the test line (T line) and the quality control line (C line) are both colored.

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative testing, only for in vitro auxiliary diagnosis.
2. This product is suitable for nasal swab samples. The results of other sample types may be inaccurate or invalid.
3. Be sure to add an appropriate amount of samples for testing. Too much or too little 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: This study uses inactivated SARS-CoV-2 virus culture, and the minimum detection limit of the kit is 6×102TCID50/mL.
2. Use the company's reference product for testing, and the results should meet the company's reference product requirements.
2.1 Qualified rate of positive control products: The company's positive control products P1-P5 are all positive.
2.2 Qualified rate of negative control products: The company's negative control products N1-N10 are all negative.
2.3 Detection limit: The minimum detection limit reference product L1-L3 is detected, L1 is negative, L2 and L3 are positive.
2.4 Reproducibility: The testing company repeats the reference materials J1 and J2, and each test is positive for 10 times.
3. Cross-reaction: Add the following concentrations of microorganisms and viruses to the sample at the specified concentration to evaluate their potential interference to the 2019 nCoV Ag test project. The results show that there is no cross-reaction and no interference from various microorganisms and viruses.

4. Interfering substances: In the 2019 nCoV-Ag testing project, the following concentrations of drugs are added to the samples at the specified concentration to evaluate their potential interference. The results showed that all kinds of drugs did not interfere with the test results of the reagent.

5. Hook effect: In the high concentration range of 1.0, no hook effect was observed × 106 TCID50/mL, 2019 nCoV inactivated culture.
6. Clinical research: use RT-PCR detection reagents as contrast reagents to evaluate nasal swab specimens. Select 120 positive and 120 negative specimens (RT-PCR test), and use Zhongxiu reagent to test. The 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 a one-time product and cannot be recycled and reused.
3. Read the instructions carefully before operation, and perform experimental operations in strict accordance with the instructions of the reagents.
4. Avoid conducting experiments under harsh environmental conditions (including 84 disinfectant, sodium hypochlorite, acid-base or acetaldehyde and other high-concentration corrosive gases, dust and other environments). Laboratory disinfection should be carried out after the experiment.
5. All samples and reagents used should be considered as potentially infectious materials and handled in accordance with local regulations.
6. The reagent should be used within the validity period indicated on the outer packaging. The test card 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 Web:www.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.