2019-NCoV Ag Rapid Test (Immunochromatography) Product Performance Indicators

Intended Use

The kit is used for qualitative detection of antibodies to 2019-N coronavirus collected from human nasal swab samples.
As a new product, 2019-NCOV is a type of β-COV. Can cause viral pneumonia, the main clinical manifestations are fever, fatigue and dry cough. A small number of patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe patients often develop dyspnea and/or hypoxemia one week later, and severe patients rapidly progress to acute respiratory distress syndrome, septic shock, refractory metabolic acidosis, and cotting dysfunction.
This product qualitatively detects 2019-N coronavirus antibodies in nasal swabs from suspected patients using lateral flow immunoassay. In the acute phase of infection, antigens are usually detected in nasal swab samples. A positive result indicates the presence of viral antigens, but the clinical correlation between the patient's history and other diagnostic information is also necessary to determine the status of the infection. A positive result does not rule out bacterial infection or co-infection with other viruses.
This kit is intended for use by the layperson in a non-laboratory setting at home (such as a personal home or some non-traditional locations such as offices, sporting events, airports, schools, etc.). The test results of this kit are for clinical reference only. It is recommended that patients be analyzed in combination with clinical findings and other laboratory tests.

Principle of Detection

This kit is an immunoassay based on the principle of double antibody sandwich technology. As an indicator, labeled 19NCOV monoclonal antibody was sprayed on the binding pad. During the test, the 2019-NCOV antibody in the sample binds to the labeled 2019-NCOV monoclonal antibody to form the Ag-antibody complex. The complex migrates upward on the membrane via capillary effect until it is captured by another 2019-N coronavirus monoclonal antibody precoated on the test line, forming a sandwich complex. If there is 2019-NCOvag in the sample, a red strip will appear in the T area of the description window. Otherwise, it will be a negative result. Control line (C) is used for program control. If the test procedure is executed correctly, it should always be displayed.

Main Components

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

Storage Conditions and Validity

It is kept at 2℃~30℃ and the validity period is tentatively set at 18 months.

Aluminum foil bags are valid for 1 hour.

Batch Number: see label for details.

Validity period: see 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 mucosa of the nostril five times, then repeat the process with the same swab on the other nostril. (See Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample processing: Samples collected should be treated with sample buffer solution provided by the kit as soon as possible (if not immediately treated, samples should be stored in a dry, sterilized and sealed container), stored at 2℃~8℃ for no more than 24 hours, and stored at -70℃ for a long time (but avoid repeated freeze-thaw).

Test Method

Please read the instructions carefully before taking the test. Please return all reagents to room temperature before testing and test at room temperature.
1. Sample processing (see Figure 2)
1. Insert the sample swab into the sample buffer and rotate it around the inner wall for about 10 times, so that the sample can be dissolved in the solution as much as possible.
2. Squeeze the tip of the swab along the inside of the tube to allow as much liquid as possible into the tube, remove and discard the swab.
3. Cover the dryer.

Figure 2 Sample processing

Figure 3 Detection procedure

2. Test procedure (see Figure 3)

1. Remove the test card.

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

3. Read the results after 15 minutes at room temperature. Twenty minutes later, the results were invalid

Interpretation of Test Results

Test card reading (Figure 4) :
① Invalid result: Quality control line (C line) has no reaction line, invalid, should be re-tested.
② Negative results: The quality control line (C line) is colored with red strips.
③ Positive results: two red strips, test line (T line) and quality control line (C line) colored.

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative detection, only for in vitro auxiliary diagnosis.
2. This product is suitable for nasal swab samples. Other sample types may have inaccurate or invalid results.
3. Be sure to add the appropriate number of samples for testing. Too many or too few samples can lead to 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. Final diagnosis of the disease should be made after a 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 reference product of our company, and the result shall meet the requirements of reference product of our company.
2.1 Conformity rate of positive reference substance: All positive reference substance P1-P5 of the company were positive.
2.2 Coincidence rate of negative control substance: n1-N10 of the enterprise were all negative.
2.3 Limit of detection: L1 should be negative, L2 and L3 should be positive for reference products of testing enterprises.
2.4 Repeatability: Repeated reference products J1 and J2 were tested in the enterprise, and the test results were positive for 10 times each time.
3. Cross-reaction: Add the following concentrations of microorganisms and viruses to the sample at the specified concentration and evaluate their potential interference to the 2019-NCOvag test item. The results showed that there was no cross-reaction and no interference from various microorganisms and viruses.

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

5. Hook effect: after the inactivated culture of 2019-ncov, no hook effect was observed in the detection range of 1.0×106TCID50/mL high concentration.
6. Clinical studies: RT-PCR reagents were used as contrast agents to evaluate nasal swab samples. A total of 120 positive samples and 120 negative samples (RT-PCR test) were selected for the detection of intermediate reagent. 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 disposable and cannot be reused.
3, please read the operation instructions carefully before operation, and strictly follow the reagent operation instructions for experimental operation.
4. Avoid experiments under harsh environmental conditions (including 84 kinds of disinfectants, sodium hypochlorite, acid and alkali, acetaldehyde and other high concentration corrosive gases and dust). The laboratory should be disinfected after the experiment.
5. All samples and reagents used should be treated as potentially infectious substances and handled in accordance with local regulations.
6. Reagents should be used within the validity period indicated on the outer package. Use as soon as possible after removing from the foil bag to prevent dampness.

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 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.
Adhering to the core concept of "speed, accuracy and life", the company is committed to providing 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.