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

Intended Use

The Kkit was purchased on the qualitative examination of the ncov-ag. Nasal exchange specimens were collected
As a new weapon, the 2019 NCOV is the major clinical symptom of β viral pneumonia is fever, weakness, and cough. Many patients develop symptoms such as a straight nose, runny nose, sore throat, or diarrhea. critically ill patients usually develop difficulty breathing or hypooxemia after a week. Serious people will quickly develop into acute respiratory difficulty syndrome, septic shock, my dental metabolic poisoning, and um blood disorders.
Through a side immune examiner, the suspected patient ncovag. was detected in 2019 Antigens were detected in nasal experiments. Benign texture and viral antigens are essential to confirm the clinical association between the patient's medical history and other diagnostic information. Benign texture along with bacterial infections or other viruses.
Remen is in non-residential environments (e. g.. G. personal housing and offices, sports activities, airports, and schools). The test results of this kit and provide clinical reference. Comprehensive analysis through clinical symptoms and other examiners.

Principle of Detection

The agent is an immunoassay kit based against the antibody coforce. The 2019 ncov monoclonal antibody table was placed on binding pads. In the test project, combined with the label test material, the ag 19 cov monoclonal antibody and ag-ab complex were captured on other 2019 ncov monoclonal antibodies and moved upward through the capillary effect as a sandwich complex. If the 2019 NCO VAG exists in the sample, red tape appears in the T area of the window. Otherwise, the result is negative. The Control Line (C) is used for program control. If the test program runs successfully, always display.

Main Components

The ruler on the reagent is wiped with a test card, a sample buffer, and a rag.
Test card: composed of aluminum foil, desiccant, test frost and plastic card. The test sheet consists of absorbing paper, knitted rocellulose film, test pads, adhesive pads, and rubber sheets. The 2019 NVab(test line was covered with the T line of the Nitro cellulose membrane) and the goat-mouse polyclonal AB(mass control line) with the C line and 2019 NVAB. On the mat.
Sample buffer: phosphate, sodium nitride, etc.

Storage Conditions and Validity

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

The aluminum foil strip is valid for one hour.
Production LOT No.: See: Detailed Tabel.
For more information, please refer to talabel.

Sample Requirements

(1) Collect nose: wipe the sample, insert the nasal cavity, tip trembling 2.5 centimeters at the nasal edge. Bend # 5 along the nasal mucosa repeatedly with the same rag (see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample treatment: The recovered samples shall be treated with the sample buffer provided in the box as soon as possible (not treated immediately, stored in dry, sterilized and sealed containers) -702 hours. C(to avoid freezing)

Test Method

Please read the instructions carefully before testing. All the reagents were determined at room temperature. Room-temperature test.
(1) Test material treatment technology (see Figure 2)
Insert the sample exchange fluid into the sample buffer and rotate to about 10 times the inner wall to dissolve the sample as dissolved in solution as possible.
1. injected the liquid into the tube in front of the inside wall of the tube and throws it away.
2.. Cover it with a hair dryer.

Figure 2 Sample processing

Figure 3 Detection procedure

(2) Examination order (see Figure 3)
The 1. took out the test card.
The 2. two drops plus μ50) places the test material into the test card for the taymer to stop working.
Read the texture and after 15 minutes at room temperature. Invalid results after 5 minutes

Interpretation of Test Results

Test card description (Figure 4)
Invalid ① result: Quality Control Line (C line) is invalid, if no response line, you need to check again.
② negative result: Quality control line (C) is a red ribbon.
③ positive texture and are all colors of two red bands, sword lateral line (T) and Quality Control Line (C).

Figure 4 Interpretation of test results

Limitation of test method

1. This product is only used for in vitro assisted diagnosis by qualitative inspectors.
2. This product is suitable for the nose shape. Other sample types are textures and may be negative or invalid.
The 3. test samples have increased significantly. Samples are too large or too small, and the results may be inaccurate.
4. could not be the sole basis for clinical trials and treatment. The final diagnosis is made only by a comprehensive evaluation of all clinical and experimental textures.

Product Performance Indicators

1. detection limit: inactivated sars-cov-2 virus with a minimum detection limit of 6 × 102 TID 50 / ML
2. company reference products for test, and the results must meet the requirements of the company reference products.
Control the 2.1 Access license rate of the product. The p. 1-p. 15 that the enterprise controls the product is certain.
2.2 Product multiple: the enterprise voice control product n1-n10 is voice.
2.3 Test: The minimum test of control product L1-L3, L1 was negative and L2, L3 was positive.
2.4 Repeatability: Standard substances J 1 and J 2 were repeatedly used in the Sword Company 10 times.
3.Cross-reaction: To assess the potential hazards of the NCO-VAG test project in 2019, the following microbes and BARES, were added to samples of fixed concentration indicating that the cross-reaction and interference of various microorganisms and viruses were absent.

4. interference: The 2019 NCO-VAG trial was planned to add the following concentrations of drugs to the sample to assess potential hazards. The results showed that all the drugs did not hinder the reagent examination results and.

5. hook effect: within the high concentration range of 1.0. No. × 106 tcid 50 / ml,19 ncov inactive cultures were not found.
6. clinical extension area was evaluated with 120 positive and 120 negative (RT-PCR side) with heavy water reagents. Textures and are equal to the following.

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 can only be used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
Read the instructions carefully before the 3. operation. The 3. shall strictly follow the reagent instructions.
The 4. laboratory avoids disinfection of 84, high concentrations of corrosive gases and dust, such as sodium hypochlorite, acid-alkali, or aldehydes.
All 5. used samples and reagents should be considered potentially infectious substances and treated in accordance with local law.
6. uses reagents for the period of validity marked on the external packaging. Use the test card after removing it from the aluminum foil pocket.

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.

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.