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

Intended Use

The tool is used for static detection of 2019-NCoV AG extracted from a human nose sample.

The 2019-nCoV is a β-CoV. Can induce viral pneumonia accompanied by fever, fatigue and dry cough of the main clinical symptoms. A small number of patients have stuffy nose, runny nose, sore throat, diarrhea and other symptoms. Severe cases often develop dyspnea and/or hypoxemia after a week, and severe cases accelerate to acute respiratory distress syndrome, septic shock, difficult to correct anacidosis, and coagulation dysfunction.

The product uses lateral flow immunoassay for static detection of nasal cotton swab specimens from suspected patients. In the acute phase of infection, antigens are usually detected from nasal swab samples. Positive results indicate the presence of viral antigens, but clinical relevance of the patient's history and other diagnostic information is also required to establish infection. A positive result does not rule out bacterial infection or co-infection with other viruses.

This kit is intended for public use and is not intended for use in non-traditional Settings (e.g. people's homes or offices, sporting events, airports, schools, etc.). The test results of this kit are for clinical reference only. Based on the patient's clinical symptoms and other laboratory tests, a comprehensive analysis of the condition is advisable.

Principle of Detection

It is based on double antibody sandwich technique for immunoassay. Monoclonal antibody 2019-nCoV was sprayed onto the binding pad as a marker. In the test, the 2019-NCoV Ag in the sample was combined with the labeled 2019-NCoV monochloroamine AB to form the Ag-Ab complex. These complexes were captured by another group of 2019-nCoV monoclonal Ab. These complexes were precoated on the test line and moved up from the membrane by capillary effect to form sandwich complexes. If your sample has 2019-NCoV AG, the red band will appear in the T-section of the analysis window. Otherwise the consequences will be negative. The control line (C) is used for program control and should always be displayed if the test procedure is running correctly.

Main Components

This kit contains a test card, a sampling buffer, and a cotton swab.

Test card: consists of aluminum foil bag, desiccant, test strip and plastic card. The test strip consists of absorbent paper, nitrocellulose membrane, sample pad, binding pad and rubber plate. Nitrocellulose membrane T-line (test line) is covered with 2019-NCoV AB, and C-line (quality control line) is covered with chloroantrophine polyvinyl chloride AB, connecting gasket contains 2019-NCoV AB with labeled label.

Sample Buffer: Phosphate, Sodium Ammonide etc

Storage Conditions and Validity

Store at 2℃~ 30℃, and the validity period is tentatively 18 months.

Aluminum foil bags are valid for 1 hour after opening.

Batch No. : See label for details.

Expiration Date: See label for details.

Sample Requirements

(1) Nasal cotton swab collection method: insert the sampling cotton swab into the nostril, and insert the tip of the cotton swab 2.5 5cm away from the edge of the nostril. Roll the swab 5 times along the mucous membrane on the inner side of the nostril and repeat the same process with the rest of the nostril. (See Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample handling: Collected samples should be processed as soon as possible using the sample buffer box provided with this toolbox (if samples cannot be processed immediately, they should be stored in a dry, sterilized, tightly sealed container). 2℃~ 8℃ within 24 hours, -70℃ for a long time storage (but can not be repeatedly frozen thaw)

Test Method

Please read the guide carefully before taking the test. All reagents should be returned to room temperature before testing and the test should be conducted at room temperature.

1. Processing of samples (see Figure 2)

1. Insert the sampling swab into the sampling buffer and rotate it approximately 10 times close to the inner wall to dissolve as much of the sample as possible in the solution.

2. Press the tip of the cotton swab along the inner wall of the tube to allow as much fluid to flow into the tube as possible. Remove the cotton swab and dispose of it.

3.Please cover the luggage rack.

Figure 2 Sample processing

Figure 3 Detection procedure

2. Test process (see Figure 3)

1. Take out your test card.

2. Add 2 drops of the treated sample (about 80μl) to the loading hole of the test card, then start the timer.

3.Please read the result after 15 minutes at room temperature. Results were invalid after 20 minutes.

Interpretation of Test Results

Interpretation of the test card (Figure 4):

① Failure results: the quality control line (line C) has no reaction line, and the failure shall be re-checked.

② Negative results: the degree management line of the red band (line C) was colored;

③ Positive results: the two red bands of trial line (T line) and quality control line (C line) are represented by color.

Figure 4 Interpretation of test results

Limitation of test method

1. This product is only used for qualitative testing and in vitro auxiliary diagnosis.

2. This product is suitable for nasal cotton swab samples. Results for other sample types may be incorrect or invalid.

3. Add appropriate sample for testing. Too many or too few samples may result in inaccurate results.

4. The test results of this reagent can only be used as clinical reference, not as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease must be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

1. Test Limitations: Inactive SARS-CoV-2 virus culture was used in this study, with a minimum kit limit of 6 × 102TCID50 / mL.

2. The test shall be carried out with enterprise reference products, and the results shall meet the requirements of enterprise reference products.

2.1 Conformance rate of training benchmark products: Enterprise training benchmark products P1-P5 shall be tested and trained.

2.2 Conformance rate of voice benchmark products: Enterprise voice benchmark products N1-N10 have been tested negative.

2.3 Test limit: the minimum test limit of the enterprise refers to product L1-L3 without error, L1 is negative, L2 and L3 are positive.

2.4 Reproducibility: the company detected repeated reference products J1 and J2, and each test should be positive for 10 times.

3. Cross Reaction: In the 2019-nCoV AG test project, microorganisms and viruses at the following concentrations were added to the sample to assess potential interference. The result is that there is no cross-reaction and no interference from a variety of microorganisms and viruses.

4. Interferences: In the 2019-nCoV AG test program, the following concentrations of the drug have been added to the sample at the specified concentration to evaluate potential interferences. The results showed that none of the drugs affected the results of the test.

5. Croke effect: A high concentration area of 1.0x106TCID50 / mL was detected in the banned 2019-nCoV medium, and no croke effect was observed.

6. Clinical study: RT-PCR reagent was used as contrast agent to evaluate nasal cotton swab samples. A total of 120 positive and 120 negative samples were screened (detected by RT-PCR) and tested with Zhongxiu reagent. The results are summarized below.

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 diagnosis outside the donor.

2. This product is a disposable product and cannot be reused or reused.

3. Before operation, please read the operation guide carefully and carry out the experimental operation according to the reagent guide.

4. Do not carry out the test under harsh environmental conditions (including 84 doses of disinfectant, sodium hypochlorite, high concentration of corrosive gases such as acid-base or acetaldehyde, dust, etc.). The laboratory should be disinfected after the experiment.

5. All samples and reagents used shall be destroyed as latent contaminants in accordance with local regulations.

6. Reagents must be used within the expiry date indicated on the outer package. To prevent moisture, the test card should be used as soon as possible after removal from the aluminum foil bag.

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.