2019-NCoV Ag Rapid Test (Immunochromatography) Interpretation Of Test Results

Intended Use

The kit is used for qualitative detection of 2019-n coronavirus antibody collected from human nasal swab samples.
As a new product, 2019-ncov is β- A kind of cov. 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. Severe patients often develop dyspnea and / or hypoxemia after 1 week. Severe patients rapidly progress to acute respiratory distress syndrome, septic shock, refractory metabolic acidosis and cotting dysfunction.
This product uses lateral flow immunoassay to detect 2019-n coronavirus antibody in nasal swabs of suspected patients. In the acute phase of infection, antigens are usually detected in nasal swab samples. Positive results indicate the presence of viral antigens, but the clinical correlation between patient history and other diagnostic information is also necessary to determine the status of infection. The positive results do not exclude bacterial infection or co infection with other viruses.
The kit is intended for non professionals to use in non laboratory environments at home (such as individual homes or some non-traditional places, such as offices, sports events, airports, schools, etc.). The test results of this kit are only for clinical reference. It is recommended to analyze patients in combination with clinical findings and other laboratory tests.

Principle of Detection

The kit is an immunoassay kit based on the principle of double antibody sandwich technology. As an indicator, the labeled 19ncov monoclonal antibody was sprayed on the binding pad. During the detection, the 2019-ncov antibody in the sample binds to the labeled 2019-ncov monoclonal antibody to form an Ag antibody complex. The complex migrates upward on the membrane through capillary effect until it is captured by another 2019-n coronavirus monoclonal antibody pre coated on the test line to form 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. The control line (c) is used for program control. If the test procedure is performed correctly, it should always be displayed.

Main Components

The kit consists of test card, sample buffer and swab.
Test card: it is composed of aluminum foil bag, desiccant, test strip and plastic card. The test paper is composed of absorbent paper, nitrocellulose film, sample pad, rubber pad and rubber sheet. Nitrocellulose membrane t line (detection line) is coated with 2019ncov antibody, 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

Stored at 2 ℃ ~ 30 ℃, the validity period is tentatively 18 months.
The validity period of aluminum foil bag is 1 hour.
Batch number: see the 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 nostril mucosa five times, and then repeat the process with the same swab on the other nostril. (see figure I)

Figure 1 Collection method for nasal swab

(2) Sample treatment: the collected samples shall be treated with the sample buffer provided by the kit as soon as possible (if not treated immediately, the samples shall be stored in dry, sterile and sealed containers), stored at 2 ℃ ~ 8 ℃ for no more than 24 hours, and stored at - 70 ℃ for a long time (but avoid repeated freezing and thawing).

Test Method

Please read the instructions carefully before taking the exam. Before testing, please put all reagents back to room temperature 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 to make the sample dissolve in the solution as much as possible.
2. Squeeze the tip of the cotton swab along the inner side of the pipe, let as much liquid as possible enter the pipe, take out and discard the cotton 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 (approx. 80 μ 50) 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 result is invalid

Interpretation of Test Results

Test card reading (Figure 4):
① Invalid result: the quality control line (line C) has no reaction line and is invalid. It shall be retested.
② Negative result: the quality control line (line C) is colored with red strips.
③ Positive results: two red bands were stained with test line (t line) and quality control line (C line).

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used 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. Be sure to add an appropriate number of samples for testing. Too many or too few samples will lead to inaccurate results.
4. The test results of this reagent are only for clinical reference and should not be used as the only 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. Detection limit: the inactivated sars-cov-2 virus culture was used in this study, and the minimum detection limit of the kit was 6 × 102TCID50/mL.
2. The test results shall meet the requirements of our company's reference products.
2.1 qualification rate of positive control samples: all p1-p5 positive control samples of the company are positive.
2.2 compliance rate of negative control substance: enterprises n1-n10 are negative.
2.3 detection limit: L1 is negative, L2 and L3 are positive.
2.4 repeatability: the repeated reference materials J1 and J2 were tested in the enterprise, and each test result was positive for 10 times.
3. Cross reaction: add the following concentrations of microorganisms and viruses to the samples with the specified concentration to evaluate their potential interference to the 2019-ncovag test project. The results showed that there was no cross reaction and no interference of 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 2019 ncov inactivation culture, at 1.0 × No hook effect was observed within the detection range of 106tcid50 / ml high concentration.
6. Clinical study: RT-PCR reagent was used as a contrast agent to evaluate nasal swab samples. A total of 120 positive samples and 120 negative samples (RT-PCR) were selected for intermediate reagent detection. 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

---

1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be reused.
3. Please read the operating instructions carefully before operation and carry out the experimental operation in strict accordance with the reagent operating instructions.
4. Avoid conducting experiments under harsh environmental conditions (including 84 disinfectants, sodium hypochlorite, acid-base, acetaldehyde and other high concentration corrosive gases and dust). The laboratory shall 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. The reagent shall be used within the validity period indicated on the outer package. Use as soon as possible after taking it out of the aluminum foil bag to prevent moisture.

Logo interpretation

---

	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

---

	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

---

Zhongxiu Technology Co., Ltd. is a high-tech enterprise specializing in the R & D, production and operation of in vitro diagnostic products. The 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 high-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.