15 Minutes Antibody Rapid Detection Kit 98.33% Standard

Intended Use

The kit is used for the qualitative detection of ncovag. Exchange specimens from nose collection
As a new weapon, 2019 ncov is a new weapon that may cause β - Viral pneumonia, the main clinical symptoms are fever, fatigue and dry cough. Many patients have a stuffy nose, runny nose, sore throat, diarrhea or other symptoms. Important patients usually develop dyspnea or hypoxemia after one week. Severe cases quickly developed into acute respiratory distress syndrome, septic shock, refractory metabolic acidosis and coagulation dysfunction.

The 2019 ncovag of suspected patients was detected by lateral immunoassay. In the nasal examination, the antigen was detected. Positive results show the presence of viral antigens, but the clinical correlation between the patient's medical records and other diagnostic information is also necessary to determine the status of infection. The positive result is that bacterial infection or simultaneous infection with other viruses cannot be ruled out.
Remen uses the kit in non residential environments (personal homes, offices, physical activities, airports, schools, etc.). The test results of this kit can only be used for clinical reference. Comprehensive analysis of clinical symptoms and other examinations.

Principle of Detection

This kit is based on the principle of double antibody sandwich technology. The ncov monoclonal antibody in 2019 is labeled and labeled on the binding pad. The test sequence is: 2019 ncovag ag19 cov monoclonal antibodies and combinations in the marked materials, 2019 ncov monoclonal antibodies in Ag AB complex are found, the body moves upward through capillarity, and the sandwich composite is formed. If there is a 2019 ncovag in the sample, a red band will appear in the T area of the description window. In addition, the results are negative. The control line (c) is used for program control. When the test program runs normally, it needs to be displayed all the time.

Main Components

The kit consists of test card, sample package 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, test pad, adhesive pad and rubber pad. In 2019nvvab (test line), t line covered with nitrocellulose film, goat mouse cycle line AB (quality management line) and C in 2019nvvab. put sth. under sth. to raise it or make it level
Sample buffer: phosphoric acid, sodium nitride, etc.

Storage Conditions and Validity

Keep it at 2 ℃ ~ 30 ℃, and the validity period is tentatively 18 months.
The aluminum foil package can be used for 1 hour.
Production batch No.: please refer to the detailed label.
Please refer to talabel for details.

Sample Requirements

(1) Collect the tip of the nose: insert the sample swab into the nasal cavity, 2.5cm from the top of the nasal cavity. The cotton swab rotates 5 times along the medial nasal mucosa, and then repeat the process with the same cotton swab (see Figure 1).

Figure 1 Collection method for nasal swab

(2) Sample treatment: recycled samples must be treated with the sample buffer attached to this box as soon as possible (do not deal with it immediately. Store it in dry, sterilized and sealed containers) - 70 within 2 hours (but avoid repeated freezing and thawing).

Test Method

Please read the instructions carefully before testing. All reagents were tested at room temperature. Test at room temperature.
(1) Treatment process of test materials (see Figure 2)
Insert the sample exchange solution into the sample buffer, rotate the sample about 10 times to the inner wall, and make it dissolve into the solution as much as possible.
1. Inject liquid into the pipe along the front end of the inner wall of the pipe and take out the waste.
2. Cover with a hair dryer..

Figure 2 Sample processing

Figure 3 Detection procedure

(2) Test sequence (see Figure 3)
1. Take out the test card.
2. Add 2 drops μ 50), put the test material into the test card and start the timer.
After 15 minutes, read the results at room temperature. After 5 minutes, the result is invalid.

Interpretation of Test Results

Description of test card (Figure 4)
① Invalid result: the quality management line (line C) is invalid and there is no response line, so it needs to be retested.
② Negative line result: the quality management line (line C) is a red ribbon.
③ The positive result is all colors of two red bands, test line (T) and quality management line (c).

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative test and only for invitro diagnosis.
2. This product is suitable for nose samples. The results of other sample types may be incorrect or invalid.
3. Properly add samples for testing. Too large or too small sample size may lead to inaccurate results.
4. It should not be the only basis for clinical trials and treatment. The final diagnosis can only be made after a comprehensive evaluation of all clinical and experimental results.

Product Performance Indicators

1. detection limit: inactivated SARS - minimum detection limit 6 × 102ttid 50 / ml cov-2 virus
2. The test using the enterprise reference product and its results must meet the requirements of the enterprise reference product.
2.1 access rate of active management products: the P1 ~ P5 of enterprises' active management products are reliable.
2.2 product time: the enterprise's negative control products N1 ~ N10 are negative.
2.3 detection limit: the minimum detection limit is detected by referring to products l 1-L 3. L 1 is negative and L2 and L3 are positive.
2.4 repeatability: the reference materials J1 and J2 are reused for 10 times by the tested company.
(3) Cross reactivity: in order to evaluate the potential interference with the 2019 NCO vag test project, the following microorganisms and viruses were added to the samples at the specified concentration: This indicates that there is no cross reactivity and interference from various microorganisms and viruses.

4. Interfering substances: in the 2019 NCO vag trial, in order to evaluate the potential interference, it is planned to add the following concentrations of drugs to the sample. The results showed that all agents did not interfere with the test results of the reagent.

5. Hook effect: within the high concentration range of 1.0. × 106 tcid 50 / ml, 19 ncov of inert culture was not found.
6. In clinical trials, RT-PCR test reagent was used to evaluate 120 positive and 120 negative (RT-PCR test), and Zhongxiu reagent was used. The results are 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 invitro diagnosis.
This product is disposable and cannot be reused.
3. Please read the instructions carefully before operation and operate in strict accordance with the reagent instructions.
4. Disinfect in the laboratory to avoid bad environmental conditions, such as 84 disinfectant, sodium hypochlorite, acid-base or acetaldehyde, other high concentration corrosive gases and dust.
5. All samples and reagents used will be considered as substances that may be infected and treated in accordance with local laws.
6. Please use the reagent within the validity period indicated on the packing box. Please use the test card as soon as possible after taking it out of 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
	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.