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

Intended Use

The kit is used for qualitative detection of 2019-nCoV Ag collected from human nose swab 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.

This product adopts a lateral flow immunoassay method for the qualitative detection of 2019-nCoV Ag in nasal swab samples from suspected patients. In the acute phase of infection, antigens are usually detected in nasal swab samples. Positive result indicates the presence of viral antigens, but the clinical relevance of the patient's medical history and other diagnostic information is also necessary to determine the infection status. A positive result can not exclude bacterial infection or co-infection with other viruses.

This kit is for home use by laymen in a non-laboratory setting (such as person’s home or certain non-traditional sites such as offices, sporting events, airports, schools etc.). The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.

Principle of Detection

This kit is an immunoassay based on the principle of double antibody sandwich technology. As an indicator marker, the 2019-nCoV monoclonal antibody labeled with a marker is sprayed on the binding pad. During the test, the 2019-nCoV Ag in the sample is combined with the labeled 2019-nCoV monoclonal Ab to form an Ag-Ab complex. This complex migrates upwards on the membrane by capillary effect until it is captured by another 2019-nCoV monoclonal Ab pre-coated at 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 interpretation window. Otherwise, it is a negative result. The control line (C) is used for program control and should always be displayed if the test procedure is executed correctly.

Main Components

The kit consists of a test card, sample buffer and swab.

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 2019-nCOV Ab, the C line (quality control line) is coated with goat anti-mouse polyclonal Ab, and the binding pad contains a 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 tentatively set at 18 months.

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

Batch number of manufacture: See label for details.

Expiration date: See label for details.

Sample Requirements

(1) Collection method for nasal swab: Insert the sampling swab into the nostril, and the swab tip should be inserted 2.5 cm from the edge of nostril. Roll the swab along the mucous membrane inside the nostril five times, and 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 sample should be processed as soon as possible with the sample buffer provided by this kit (if it cannot be processed immediately, the sample should be stored in a dry, sterilized and strictly sealed container), stored for no more than 24h at 2℃～8℃, and kept for a long time at -70℃ (but avoid repeated freezing and thawing)

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. Sample processing (see Figure 2)

1. Insert the sampled swab into the sample buffer, and rotate it close to the inner wall about 10 times to dissolve the sample in the solution as much as possible.

2. Squeeze the swab tip along the inner wall of tube to keep 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 80μL) of the processed sample extract to the loading well of test card, and then start the timer.

3. Read the results when the card is placed at room temperature for 15 minutes. The result is invalid after 20 minutes.

Interpretation of Test Results

Interpretation of test card (Figure 4):

① Invalid result: It is invalid with no reaction line on the quality control line (C line ), so the test should be taken again.

② Negative result: The quality control line (C line), a red color band, is colored.

③ Positive result: 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 for qualitative detection and is only used for in vitro auxiliary diagnosis.

2. This product is applicable to nasal swab samples. Other sample types may have inaccurate or invalid results.

3. Make sure to add an appropriate amount of sample for test. Too much or too little sample volume may result in inaccurate results.

4. 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. Test limit: This study uses inactivated SARS-CoV-2 virus culture, and the minimum test limit of the kit is 6×10²TCID₅₀/mL.

2. Use corporate reference products for test, and the results should meet the requirements of corporate reference products.

2.1 Conformity rate of positive reference products: The corporate positive reference products P1-P5 shall all be positive for the test.

2.2 Conformity rate of negative reference products: The corporate negative reference products N1-N10 shall all be negative for the test.

2.3 Test limit: Corporate minimum test limit reference products L1-L3 are detected, L1 should be negative, L2 and L3 should be positive.

2.4 Reproducibility: Corporate repeated reference products J1 and J2 are detected, and shall all be positive for 10 times of respective detection.

3. Cross reaction: The following concentrations of microorganisms and viruses were added to the samples at the specified concentrations to evaluate their potential interference in 2019-nCoV Ag test project. The results showed no cross reactions, and were not be interfered by various microorganisms and viruses.

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

5. Hook effect: No hook effect was observed in detecting high concentration range of 1.0×10⁶TCID₅₀/mL with inactivated 2019-nCoV culture.

6. Clinical research: RT-PCR detection reagents were used as contrast reagents to evaluate nasal swab samples. 120 positive and 120 negative samples (detected by RT-PCR) were selected and detected with Zhongxiu test reagent. The results were 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, which can not be recycled and reused.

3. Read the instructions carefully before operation, and carry out the experimental operation in strict accordance with the reagent instructions.

4. 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.

5. All samples and used reagents should be regarded as potentially infectious substances and disposed of in accordance with local regulations.

6. 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

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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.