Device Gmate Rtk COVID-19 Ag Rapid Test Kit Sodium Azide

COVID-19 Ag Rapid Test Device Gmate Rtk

Intended Use

The kit is for qualitative testing of nCoV Ag 2019 strains taken from human nose wipe samples.
The 2019 nCOV is the new nCOV. Viral pneumonia can be caused and the main clinical symptoms are fever, lethargy and dry cough. Many patients have symptoms such as stuffy nose, runny nose, sore throat, and diarrhea. Severe patients usually develop dyspnea and / or hypoxemia after 1 week, and severe patients rapidly develop acute respiratory distress syndrome, infectious shock, difficulty in correcting metabolic acidosis, coagulation dysfunction, etc. Proceed.
This product was qualitatively tested by transverse flow immunoassay on a pseudo-nasal wipe sample of 2019 nCoV Ag. During the acute phase of infection, antigen is usually detected in nasal swap samples. A positive result indicates the presence of a viral antigen, but a clinical correlation between the patient's medical history and other diagnostic information is also needed to identify the infection status. Positive results do not rule out bacterial or mixed infections with other viruses.
This kit can be used by the general public at home in non-laboratory environments (human homes and non-traditional places such as offices, sporting events, airports, schools). The test results of this kit are for clinical reference only. It is advisable to perform a full analysis of the condition based on the patient's clinical symptoms and other laboratory tests.

Principle of Detection

This kit is an immunoassay kit based on the principle of two-antibody concentric technology. The 2019 ncov monoclonal antibody bearing this marker was sprayed onto the binding sheet as an indicator marker. During the course of the test, the 2019 ncov Ag in the sample is bound to the labeled 2019 ncov monoclonal antibody to form the ag-ab complex. The complex was elevated by the capillary effect and was separately packaged on the test line until the sandwich complex was formed by the 2019 ncov monoclonal antibody. A red stripe appeared in the T zone of ncov Ag in 2019. This is the explanation window in the sample. Otherwise, this is a negative result. The control line (c) is used for program control. If the test program runs correctly, it should always be visible.

Main Components

The kit consists of a test card, sample buffer and a wipe.
Test card: Consists of aluminum foil packaging, desiccant, test sheet, plastic card. Of these, the test paper consists of a water-absorbent paper, a cellulose nitrate film, a test sample pad, an adhesive pad and a rubber plate. The nitrocellulose membrane T line (test line) is packaged with 2019 nCOV Ab, C line (QC line), coated with goat anti-mouse multiclonal antibody, and the binding pad is labeled 2019 nCOV Ab.
Sample buffer: Phosphate, sodium nitride, etc.

Storage Conditions and Validity

Stay at 2 ℃ ~ 30 ℃, tentatively valid for 18 months.

The unpacking aluminum foil package is valid for one hour.

Production batch number: See the label for details.

Validity period: See the label for details.

Sample Requirements

(1)How to remove the nostril: Insert the sample swap into the nostril and insert the tip into the nostril edge 2.5 cm. Turn the brush 5 times along the mucous membrane of the nose and repeat the same for the other nose with the same brush.(see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample processing: Collected samples should be treated with the sample buffer provided by the kit as soon as possible (if not immediately, stored in a dry, sterile, sealed container), stored within 2 hours, temperature 24 hours ° C. Maintain -70 ° C without exceeding ~ 8 ° C (but avoid repeated freezing and thawing)

Test Method

Please read the instructions carefully before the test. Bring all reagents to room temperature before testing. The test should be conducted at room temperature.
1 Sample processing (see Fig. 2)
1. Insert the sample swap into the sample buffer and rotate it approximately 10 times near the inner wall to allow the sample to dissolve as much as possible in the solution.
2. Squeeze the tip of the wipe along the inner wall of the tube, pour as much liquid as possible into the tube, take out the wipe and put it in the house.
3. Cover with water 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

Test card description (Figure 4):
Invalid ① Result: Quality control line (C line) The response line is invalid and should be rediscovered.
② Negative result: Quality control line (C) is a red ribbon.
③ Positive result: 2 red bands, test (T) and quality control (C).

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative tests and is used only for in-vitro assisted diagnosis.
2. This product is suitable for nose wipe samples. The results of other types of samples may be inaccurate or invalid.
3. An appropriate amount of sample must be added and tested. If the sample size is too large or too small, the results may be inaccurate.
4. The test results of this reagent are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. A final diagnosis can be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

1. Detection limit: When using inactivated novel coronavirus culture, the minimum detection limit of the kit is 6 × 102 TCID 50 / mL.
2. Tested using the company reference product, the results should meet the company reference product requirements.
2.1 Positive quality control products Pass rate: P1-P5 Positive All quality control products are positive.
2.2 Negative control pass rate: All negative controls N1-N10 are negative.
2.3 Test limit: Minimum test limit Reference product L1-L3, L1 Negative and positive L2 and L3.
2.4 Reproductivity: J1 and J2, 10 times each time.
3. Cross-reactivity: Add the following concentrations of microorganisms and viruses to the sample at the specified concentrations to assess potential interference with the 2019 nCoV Ag test program. As a result, it was found that there was no cross-reactivity and no interference by various microorganisms and viruses.

4. Interference: The 2019 nCoV Ag test program will add the following concentrations to the sample at the specified concentration to assess its potential interference. As a result, none of the drugs interfered with the test results of the reagents.

5. Hook effect: No 106 TCID 50 / ml × 2019 nCoV inactivated cultures were observed in the high concentration range of 1.0.
6. Clinical study: Evaluate nasal wipe samples using reverse transcription polymerase chain reaction detection reagent as a comparative agent. Select 120 positive samples and 120 negative samples (rt-pcr test) and detect with xiu reagent. The results can be 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 used only for in vitro diagnosis.
2. This product is a disposable product and cannot be collected.
3. Read the instructions carefully before operating and perform the experimental operation strictly according to the reagent instructions.
4. Avoid experiments in harsh environments containing high concentrations of corrosive gas, dust, sodium hypochlorite, alkalis and acetaldehyde. The laboratory must be disinfected after the experiment is over.
5. All samples and reagents used by the company are considered potential contagious substances and are treated according to local regulations.
6. Reagents should be used within the shelf life specified on the package. Remove the test card from the aluminum foil bag and use it as soon as possible 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.

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