COVID-19 Test Kit Lateral Flow Test Kits Product

Intended Use

The kit was used for qualitative detection of 2019 ncovag and was collected from human nasal swab samples.
2019-ncov is a new type of ncov. It can cause viral pneumonia. The main clinical symptoms are fever, fatigue and dry cough. Some patients develop nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe cases usually develop dyspnea and / or hypoxemia after one week. Severe cases quickly develop into acute respiratory distress syndrome, septic shock, difficult to correct metabolic acidosis and coagulation dysfunction.
The product was qualitatively tested on 2019 ncovag suspicious nasal swab samples by nasal chromatography. In the acute phase of infection, the antigen is usually detected in nasal swab samples. Positive results indicate the presence of viral antigens, but the clinical relevance of the patient's medical records and other diagnostic information is also needed to determine the infection status. Positive results do not exclude bacterial infection or mixed infection with other viruses.
This kit is used in the homes of laymen in environments outside the laboratory (such as human homes, offices, sports activities, airports, schools and other specific non-traditional places). The test results of this kit are only for clinical reference. It is suggested to conduct a comprehensive analysis of the condition according to the patient's clinical manifestations and other clinical examinations.

Principle of Detection

This kit is based on the principle of double antibody sandwich technology. The 2019ncov monoclonal antibody labeled with the marker is sprayed on the binding pad as an indicator marker. During the test, it was combined with 2019ncov monoclonal antibody labeled 2019ncov - Ag in the sample to form Ag AB complex. The complex moves upward through the capillary effect to form a sandwich complex until it is captured by another pre grouping of 2019 ncov monoclonal antibody on the test line. A red band will appear in the T area of the 2019ncov Ag interpretation window of the sample. If not, it is the result of negation. The control line (c) is used for program control. If the test program runs correctly, it should always be displayed.

Main Components

The kit is composed of test card, sample bag and cotton swab.
Test card: it is composed of aluminum foil packaging, desiccant, test strip and plastic card. The test paper is composed of absorbent paper, nitrocellulose film, sample pad, bonding pad and rubber plate. Nitrocellulose film T-line (test line) is packaged as 2019ncov AB and c-line (QC line), which are wrapped with Goat anti infective antibody and 2019ncovab label binding pad.
Sample buffer: phosphoric acid, sodium nitride, etc.

Storage Conditions and Validity

It is effective for 18 months at 2 ℃ ~ 30 ℃.
Aluminum foil unpacking is valid for 1 hour.
Production 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 insert the swab piece 2.5cm from the edge of the nostril. The cotton swab rotates five times along the nasal mucosa, and then repeat the process with the same cotton swab for the other nostrils (see Figure 1).

Figure 1 Collection method for nasal swab

(2) Sample processing: the collected samples are provided as this kit. They are processed as soon as possible (if not immediately, they are kept in sealed containers after drying and sterilization) and kept within 2 hours and 24 hours. Keep it at - 70 ℃ (but avoid repeated thawing and freezing)

Test Method

Please read the instructions carefully before testing. Restore all reagents to room temperature before testing. The test must be carried out at room temperature.

1. sample processing (see Figure 2)

1. inserts the sample swab into the sample buffer and rotates near the inner wall for about 10 times to dissolve the sample in the solution as much as possible.

2. squeezes the swab tip along the inner wall of the tube to flow as much liquid as possible into the tube, remove and discard the swab.

3. Cover with the drops.

Figure 2 Sample processing

Figure 3 Detection procedure

2. Test procedure (see Figure 3)

1. took out the exam card.

The 2. adds 2 drops (about 80 μ50) extracts the processed sample into the loading hole of the test card and then activates the timer.

3. read the results after 15 minutes at room temperature. Invalid results after 20 minutes.

Interpretation of Test Results

Description of the test card (Figure 4):
Invalid ① result: Quality Control Line (C Line) no response line is invalid and should be redetected.
② negative result: Quality control line (C) is red ribbon.
③ positive results: two red bands, test (T) and mass control (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 nasal swab samples. The results of other sample types may be incorrect or invalid.
3. In order to test, it is necessary to add an appropriate number of samples. Too large or too small sample size may produce 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 can only be made after a comprehensive evaluation of all clinical and examination results.

Product Performance Indicators

1. test limit: when inactivated New Coronavirus was incubated, the minimum test limit of the kit was 6. × 102tcid50 / mL.
2. Use the company's reference products for testing, and the results must meet the requirements of the company's reference products.
2.1 recognition rate of positive quality management products: all p1-p5 positive quality management products are positive.
2.2 recognition rate of negative control products: all negative control products N1 ~ N10 are negative.
2.3 detection limit: the minimum detection limit refers to products L1-L3, and the negative and positive L2 and L3 of L1.
2.4 reproducibility: J1 and J2, 10 times at a time.
3. Cross reactivity: in order to evaluate the potential interference to the 2019 ncov Ag test plan, the following concentrations of microorganisms and viruses were added to the sample at the specified concentration. The results showed that there was no cross reaction and no interference of various microorganisms and viruses.

4.Interference: the 2019ncov - Ag test plan adds the following concentrations to the sample at the specified concentrations to evaluate potential interference. The results showed that all drugs did not interfere with the test results of the reagent.

5. Hook effect: × 106tcid50 / ml, 2019ncov inactivated culture was not observed in the high concentration range of 1.0.
6. Clinical trial: nasal swab samples were evaluated using reverse transcription polymerase chain reaction test reagent as contrast agent. 120 positive samples were selected and 120 negative samples (RT-PCR test) were tested by Xiu reagent. 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

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1. This product is only used for invitro diagnosis.
2.This product can only be used once and cannot be reused.
3. Please read the instructions carefully before operation and carry out the experimental operation in strict accordance with the reagent instructions.
4. Avoid experiments under harsh environmental conditions such as high concentration corrosive gas, dust, sodium hypochlorite, acid-base or acetaldehyde. The disinfection of the laboratory should be carried out after the experiment.

5. All samples and reagents used in the will be considered potentially infectious and handled in accordance with local regulations.
6. The period of validity shall be indicated on the package. The test card should be used as soon as possible after being removed from the aluminum foil bag to prevent moisture.

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.