BfArm Whole Blood Antigen Test Nasal Swab Self Test At Home Useful

Intended Use

Kkit was purchased through the qualitative detection of ncov AG. Nasal specimens were collected
As a new weapon, the ncov in 2019 is β The main clinical symptoms of viral pneumonia are fever, fatigue and cough. Many patients will have a straight nose, runny nose, sore throat or diarrhea. Severe patients usually develop dyspnea or hypoxemia after one week. Severe cases will soon develop into acute dyspnea syndrome, septic shock, metabolic poisoning of my teeth, and blood disorders.
Through the Deputy immune examiner, the suspected patient is ncovag. It was detected in 2019. The antigen was detected in the nose experiment. Benign textures and viral antigens are essential to confirm the clinical link between the patient's medical record and other diagnostic information. Benign textures are associated with bacterial infections or other viruses.
Remen is located in a non residential environment (e.g. private homes and offices, sports activities, airports, schools). Provide the test results and clinical reference of this kit. Comprehensive analysis of clinical symptoms and other prosecutors.

Principle of Detection

This is a drug based on antibody adjuvant. The 2019ncov monoclonal antibody table was configured on the binding pad. In the test project, combined with the label test data, the Ag 19cov monoclonal antibody and Ag AB complex were captured by other 199ncov monoclonal antibodies and moved upward through the capillary phenomenon as a sandwich complex. If 2019 NCO vag is present in the sample, the red tape will be displayed in the T area of the window. In addition, the results are negative. The control line (c) is used for program control. If the test program works normally, please keep it displayed.

Main Components

Wipe the reagent ruler with test card, sample bag or cloth.
Test card: it is composed of aluminum foil, desiccant, test cream and plastic card. The test paper is composed of absorption paper, nickel filiform film, test pad, adhesive pad and rubber pad. 2019nvab (the test line is covered with t line of nitrocellulose film) and goat mouse clone line AB (quality control line) are covered with C line and 2019nvab. On the mat.
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 strip can be used for 1 hour.
Production batch number: see the table for details.
Please refer to talabel for details.

Sample Requirements

(1) Collect the tip of the nose: wipe the sample, insert it into the nasal cavity, and shake it with the tip of the nose for 2.5cm. Repeat bending # 5 with the same rag along the nasal mucosa (see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample processing: the recovered samples shall be processed as soon as possible in the sample buffer prepared in the box (do not process immediately, but store in a dry and sterilized sealed container) - 702 hours. C (to avoid freezing)

Test Method

Please read the instructions carefully before testing. All reagents were determined at room temperature. Room temperature test
(1) Test material treatment technology (see Figure 2)
Insert the sample exchange solution into the sample buffer and rotate it about 10 times to the inner wall to make the sample dissolve in the solution as much as possible.
1. Inject liquid into the pipe in front of the inner wall of the pipe and pour it out.
2. Cover with a hair dryer.

Figure 2 Sample processing

Figure 3 Detection procedure

(2) Review sequence (refer to figure 3)
1. Take out the test card.
2. 2 drops and μ 50) place the test material on the test card to stop Tingmei from working.
Read the texture after 15 minutes at room temperature. Invalid results after 5 minutes

Interpretation of Test Results

Test card description (Figure 4)
Invalid ① Result: the quality management line (line C) is invalid. If there is no answer line, it needs to be confirmed again.
② Negative result: the quality management line (c) is a red ribbon.
③ Front hand feel, all colors of two red bands: knife side line (T) and quality management line (c).

Figure 4 Interpretation of test results

Limitation of test method

1. This product is only used for invitro auxiliary diagnosis of qualitative inspector.
2. This product is suitable for the shape of the nose. Other sample types are textures and may be negative or invalid.
3. Test samples increased significantly. Because the sample is too large or too small, the result may be inaccurate.
4. It cannot be the only basis for clinical trials and treatment. The final diagnosis can only be made through a comprehensive evaluation of all clinical and experimental textures.

Product Performance Indicators

1. Detection limit: the minimum detection limit is 6 × Inactivated sars-cov-2 virus with 102tid 50 / ml
2. The test results of the company's reference products must meet the requirements of the company's reference products.
2.1 control the access rate of the product. p. 1 - p. 15. Enterprises are indeed managing products.
2.2 multiple products: enterprise voice control products n1-n10 are voice.
2.3 test: the minimum test of L1-L3 and L1 of control products is negative, and L2 and L3 are positive.
2.4 repeatability: reference materials J1 and J2 have been repeatedly used for 10 times in swordcompany.
3. Cross reactivity: in order to evaluate the potential hazards of nco-vag test project in 2019, the following microorganisms and bares were added to the samples with fixed concentration, indicating that various microorganisms and viruses have no cross reactivity and interference.

4. Interference: in the nco-vag trial in 2019, in order to evaluate the potential hazards, it is planned to add the following concentrations of drugs to the sample. The results showed that all agents did not hinder the reagent test results.

5. Hook effect: within the high concentration range of 1.0. No. × 106tcid 50 / ml, 19ncov no inert culture was found.
6. The clinical expansion area was evaluated by heavy water reagent 120 positive and 120 negative (RT-PCR side). The texture is shown 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

1. This product can only be used for invitro diagnosis.
2. This product is disposable and cannot be reused. Please read the instructions carefully before operation.
3. Strictly follow the instructions of the reagent.
4. The laboratory shall avoid disinfection of 84 kinds of corrosive gases and dust with high concentration, such as sodium hypochlorite, acid-base, aldehyde, etc.
5. All used samples and reagents are considered as substances that may be infected and must be treated in accordance with local laws.
6. Please use the reagent indicated on the external package within the validity period. Please take out the test card from the aluminum foil pocket for use.

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.