COVID-19 Antigen Rapid Test kit(Colloidal Gold)

This product is used for in vitro qualitative detection of the antigen of novel corona virus in human throat swabs or nasal swabs.

Manufacturer :Sichuan Zhengning Medical Equipment Co., Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.weishield.com Page 1 / 27

Version:（201213） WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

WEISHI MEDICAL

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page1/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

About the Product

▅ Product Presentation...... page2-4

▅ Product instructions for Use...... page5-9

▅ Packaging ...... page10-11

▅ Product picture ...... page12

▅ Product usage Scenario...... page13

▅ About the Factory...... page14

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page2/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

(1) Portable: No instruments required for visual inspection

(2) Simple: Simple operation,easy to use

(3) Fast: 20-30 minutes to read the results

Patient demographics (gender, age, time elapsed since onset of symptoms) are available for the 321samples used in the analysis. The table below shows the positive results broken down by age of the patient:

Age AmonMed COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

Total# Positive Prevalence

≤5years 0 0 0

6 to 21 years 0 0 0

22 to 59 years 189 63 33.33%

≥60 years 132 38 28.79%

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page3/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Sampling:

Oropharyngeal Swab

Nasopharyngeal Swab

The novel corona virus belong to the β genus. COVID-19 is an acute respiratory infectious

disease. People are generally susceptible. Currently, the patients infected by the novel corona

virus are the main source of infection; asymptomatic infected people can also be an infectious

source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days,

mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough.

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page4/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

【NOTE】The package insert must be read carefully prior to use and should be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Product Name: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Intended Use: This product is used for in vitro qualitative detection of the antigen of novel corona virus in human throat swabs or nasal swabs. The novel corona virus belongs to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel corona virus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. Test Principle: This kit uses immunochromatography for detection. The specimen will move forward along the test card under capillary action. If the specimen contains a novel corona virus antigen, the antigen will bind to the colloidal gold-labeled new corona virus monoclonal antibody. The immune complex will be captured by corona virus monoclonal antibodies which are membrane fixed, form the fuchsia line, display will be corona virus antigen positive; If the line does not show color, the negative result will be displayed. The test card also contains a quality control line C, which shall appear fuchsia regardless of whether there is a detection line.

Main Component:

Content Number Component 25 Test-Kit The nitrocellulose membrane coated with new corona virus monoclonal antibody and goat anti-rabbit IgG antibody 1 test/bag 1 Test-Card The conjugate pad of colloidal gold-labeled new corona virus 25 bags/kit monoclonal antibody and rabbit IgG antibody

Antigen 1% tritonX-100, 150mM Nacl, 1% sodium deoxycholate, 0.1% 5mL×2 2 extraction SDS, Tris-Hcl buffer (pH7.4) bottles R1 3 Antigen extraction tube 1×25pieces 4 Nasopharyngeal swab 1×25pieces 5 Instruction for Use 1×1piece

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page5/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Storage conditions & period of validity: ◆ Store at 2℃~30℃, and it is valid for 18 months. ◆ After the aluminum foil bag is unsealed, the test card should be used as soon as possible within one hour. Specimen request: 1.Throat swab: Let the patient's head tilt slightly, mouth open, and make "ah" sounds, exposing the pharyngeal tonsils on both sides. 2.Nasal swab: Let the patient's head relax naturally, and slowly rotate the swab against the wall of the nostril into the patient's nostril to the nasal palate, and then slowly remove it while wiping. Using the same swab, wipe the other nostril in the same way; place the swab specimen in the extraction tube with the extraction solution added in advance, rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the swab antigen. 3.Nasopharyngeal swabs: Place the nasal swab into the sampling tube where the pharyngeal swab has been collected. In this way, there is a pharyngeal swab and a nasal swab in a sampling tube, so-called nasopharyngeal swab tube. Place the swab specimen in the extraction tube, rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the antigen in the swab.

Test methods:

The test method was colloidal gold. Please read the manual and the instrument operation manual carefully before use. 1.Open the package and take out the test card. 2.Place the extraction tube on the workbench. The swab extractor bottle (R1) is pressed vertically downward to allow the solution to drip freely into the extractor tube without touching the edge of the tube. Add 6 drops of R1 to the extractor tube. 3.Put the swab specimen into the extraction tube, rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the antigen in the swab. Squeeze the swab over the head to remove the swab so as to remove as much liquid as possible from the swab. Dispose of swabs according to biohazard waste disposal method. 4.Install the beater on the extraction tube, put two drops into the specimen hole of the test card, and start the timer. 5.Read the results within 20 minutes. Strong positive results can be reported within 20 minutes, however, negative results must be reported after 20 minutes, and the results after 30 minutes are no longer valid.

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page6/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Operating steps:

The test should be operated at room temperature (15-30℃)

Step 1 Step 2 Step 3 Step 4

Remove the swab Apply 2 drops of extracted Insert the swab into an extraction while squeezing the Press the nozzle specimen to the specimen buffer tube. While squeezing the sides ofthe tube to cap tightly onto well of the test device.Read buffer tube, stir the swab more than 5 extract the liquid the tube. the test result in 20-30 times. from the swab. minutes.

Interpretation of test results:

■ Negative result:if there is only a quality control line C, the detection line is colorless, indicating that novel coronavirus. ■ Positive result: if both the quality control line C and the detection line appear, novel coronavirus antigen has been detected and the result is positive for antigen. ■ Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line (asshown in the figure below), and the test shall be conducted again.

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page7/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

The results show

negative positive invalid

Limitations of inspection methods: ◆This reagent is only used for in vitro diagnosis. ◆This reagent is only used to detect human nasopharyngeal swab extracts. The results of other specimens may be wrong. ◆This reagent is only used for qualitative detection and cannot indicate the level of novel corona virus antigen in the specimen. ◆This reagent is only a clinical auxiliary diagnostic tool. If the result is positive, it is recommended to use other methods for further examination in time and the doctor’s diagnosis shall prevail.

Precautions:

(1)Read the instructions carefully before using the kit, and strictly control the reaction time. If you do not follow the instructions, you will get inaccurate results. (2)The specimen shall be tested in a laboratory with certain conditions. All specimens and materials during testing should be handled in accordance with the laboratory practice for infectious diseases. (3)Guard against moisture, do not open the aluminum platinum bag before it is ready for testing. Do not use the aluminum foil bag when it is damaged or the test card is damp. (4)Please use it within the validity period. (5)Balance all reagents and specimens to room temperature before use. (6)Do not replace the components in this kit with components in other kits. (7)Do not dilute the specimen for testing, otherwise you may get inaccurate results. (8)The kit shall be stored in strict accordance with the conditions specified in this manual. Please do not store the kit under freezing conditions. (9)The test methods and results must be interpreted in strict accordance with this specification. (10)Negative results will occur with this kit if the novel corona virus antigen in the specimen falls below the minimum detection limit for this kit.

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page8/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Index of CE Symbols:

Xiamen AmonMed Biotechnology Co., Ltd. 120 Xinyuan Road, Haicang District, Xiamen, Fujian People's Republic of China

SUNGO Europe B. V. Address :Olympisch Stadion 24, 1076DE Amsterdam, Netherlands E-mail:ec.rep@sungo group.com Tel :+31(0)202111106

Key to symbols used in the package

In Vitro Diagnostic Medical Device Manufacturer

Batch code Do Not Reuse

Store in this position only. Keep Fragile, handle with care upright

Keep dry Store at 2 °C~30°C

Consult Instructions for Use Expiration Date

Authorized representative in the Date of manufacture European Community

CE Mark Keep away from sunlight

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page9/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Packing specification (Model A) ■ Unit:25 tests/kit

Each box contains:25test-Card Test kit,2Antigen extraction R1,25 Antigen extraction tube,25 Nasopharyngeal swab

25 2Antigen 25 Antigen extraction tube 25 Nasopharyngeal 1 Test-Card extraction R1 swab Instructions

UNIT QUANTITY SIZE GROSS WEIGHT

1BOX 25tests 180*135*125mm 400g

1CARTON 24boxs (600tests) 520*380*440mm 9.6kg

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page10/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Packing design:

Box size :180*135*125mm

Craton size :520*380*440mm

【※】The packing is made of reinforced and thickened materials to ensure that the products are not easily damaged in the long distance transportation and can be well protected.

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page11/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Product picture:

Antigen extraction R1 Test-Card

Antigen extraction tube Antigen extraction tube

Box open view Nasopharyngeal swab

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page12/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Applicable scene

School; Shopping mall Hospital

Factory Residential district Company

Applicable to: clinical coronavirus detection and screening ,community testing,school resumption,enterprise resumption of work,asymptomatic or susceptible population(Please use the product under the professional guidance of the medical institution and in accordance with the product manual)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page13/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

About the factory

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page14/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

More Certification

▅ CE certificate...... page16-17

▅ EC Declaration of Conformity...... page18-19

▅ CIBG Certificate of Registration...... page20-21

▅ NQA Certificate of Registration...... page22

▅ Export qualification documents...... page23

▅ Production certificate...... page24-25

▅ WHO Emergency Use Listing ...... page(in the end)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page15/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page16/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page17/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page18/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page19/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page20/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page21/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page22/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page23/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page24/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue, Juntun Town, Xindu District, Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.zhengningmask.com Page25/ 27 WEI SHI MEDICAL COVID-19 Antigen Rapid Test kit(Colloidal Gold)

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Brand/dealer :Sichuan Zhengning Medical Equipment Co., Ltd. Factory:Xiamen AmonMed Biotechnology Co.,Ltd. Address:No. 3, Building 2, No. 388, Food Avenue,Welcome Juntun Town, to contact Xindu District, us Chengdu, Sichuan, China TEL:86-28-85184896 Web：www.weishield.com Version:（201216） Page26/ 27