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

Intended Use

Kkit are used for qualitative detection of ncov ag. collected from nasal exchange specimens
As a new weapon, the 2019 NCOV is a new weapon that can cause β-viral pneumonia, the main clinical symptoms are fever, fatigue and dry cough. Many patients have nasal congestion, runny nose, sore throat, diarrhea or other symptoms. Critical patients usually develop dyspnea or hypoxemia after a week. Severe cases quickly developed into acute respiratory distress syndrome, septic shock, refractory metabolic acidosis, coagulopathy disorder.
The ncovag of 2019 in the suspected patient was detected by lateral immune examination. In the nasal test, the antigen was detected. The positive results showed the presence of viral antigen, but the clinical correlation between the patient's history and other diagnostic information is also necessary to determine the infection status. The positive results could not exclude bacterial infection or co-infection with other viruses.
The kit is used by Reemen in a non-resident environment (e. g. private homes and offices, physical activities, airports, and schools). The test results of this kit are available for clinical reference only. A comprehensive analysis through clinical symptoms and other tests.

Principle of Detection

The kit is an immunoassay kit based on the principle of dual antibody sandwich technology. The ncov monoclonal antibody of 2019 labeled as labeled on the binding pad. In the test procedure, Combined to the ag 19 cov monoclonal antibody of 2019 ncov ag in the labeled test material, The ag―ab complex was captured by another 2019 ncov monoclonal antibody, Moving upward through the capillary effect, Until the sandwich complex is formed. If the NCO VAG of 2019 exists in the sample, The red band appears in the T area of the explanation window. Otherwise, The result is negative. The Control Line (C) is used for program control. If the test program runs successfully, It must always be displayed.

Main Components

The kit consists of test cards, sample buffer, and SWAB.
Test card: composed of aluminum foil bag, desiccant, test strip and plastic card. Test sheet consists of absorbent paper, nitrocellulose film, test pad, adhesive pad and rubber sheet. t line covering nitrocellulose film with 2019 nvvab (test line), c with goat-mouse polyclonal ab (quality management line) and 2019 nvvab. on the pad
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.

Aluminum foil bag is valid for 1 hour.
Production lot number: See: Details Label.
For more information, see talabel.

Sample Requirements

(1) Snose collection: insert the sample swab into the nasal cavity and the tip 2.5 cm from the edge of the nasal cavity. Roll the swab along the inner nasal mucosa 5 times and repeat the process with the same swab (see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample Treatment: The recycled samples shall be treated as soon as possible with the sample buffer solution provided as this box (should not be treated immediately, they shall be stored in dried, sterilized and sealed containers) -70 stored within 2 hours ℃ (but avoid repeated freezing and thawing)

Test Method

Read the instructions carefully before testing. Test all reagents to room temperature. Test at room temperature.
(1) Test material treatment process (see Figure 2)
Insert the sample exchange into the sample buffer and rotate to about 10 times the inner wall for the sample to dissolve as much in solution as possible.
1. Pour the liquid into the pipe along the front end of the inner wall of the pipe, take out and discard.
2. Cover with the hair dryer.

Figure 2 Sample processing

Figure 3 Detection procedure

(2) Test sequence (see Figure 3)
The 1. takes out the test card.
The 2. adds 2 drops of μ50) to put the test material into the test card and start the timer.
Read the results after 15 minutes at room temperature. After 5 minutes, the results are invalid

Interpretation of Test Results

Test card description (Figure 4)
① Invalid result: Quality Control Line (Line C) is invalid, no response line, and should be tested again.
② negative line result: The quality control line (line C) is a red ribbon.
③ The positive result is: two red bands, test line (T) and Quality Control Line (C) all colors.

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative testing and only for in vitro assisted diagnosis.
2.This product applies for nose samples. Other sample type results may be inaccurate or invalid.
3. appropriately adds samples for testing. Too large or too small sample size may lead to inaccurate results.
4.It should not be the sole basis for clinical trials and treatment. The final diagnosis can be made after a comprehensive evaluation of all clinical and experimental results.

Product Performance Indicators

1. detection limit: inactivated sars―cov-2 virus with the minimum detection limit of 6 × 102 TTID 50/ML
2. tests using company reference products and the results shall meet the requirements of company reference products.
2.1The access rate of positively controlled products: the P 1-P 5 of the enterprise positively controlled products is certain.
2.2 Product times: N 1-N 10 of enterprise negative control products are negative.
2.3 Detection limit: minimum detection limit reference product L 1-L 3 is detected, L 1 is negative, L 2 and L 3 are positive.
2.4 Repeatability: Standard substances J 1 and J 2 are reused by the testing company 10 times.
(3) Cross-reaction: To assess potential interference with the 2019 NCO VAG test project, the following microbes and viruses were added to samples of a specified concentration, indicating that there was no cross-reaction and interference from various microbes and viruses.

4. Interference substances: The 2019 NCO VAG trial was planned to add the following concentrations of drugs to the samples to assess their potential interference. The results showed that all drugs did not interfere with the test results of the reagent.

5. Hook effect: within the high concentration range of 1.0. No × 106 tcid 50/ml,no 19 ncov inactive culture was found.
6. Clinical studies used RT-PCR test reagent to evaluate 120 positive and 120 negative (RT-PCR test) and used Zhongxiu reagent. The results were 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 used for in vitro diagnosis only.
2. This product is disposable and cannot be recycled.
3. Read the instructions carefully before 3. operation and strictly follow the reagent instructions.
4. Avoid severe environmental conditions including disinfectant 84, sodium hypochlorite, acid and alkali or acetaldehyde, other high concentrations of corrosive gases and dust, etc., the laboratory shall disinfect.
5. All samples and reagents used shall be considered as potentially infectious materials and shall be treated in accordance with local legislation.
6. Use reagents within the validity period indicated in the outer package. Use the test card as soon as possible after removal from 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.