SARS-CoV-2 Ag Test Kit Colloidal Gold for Professional 10 Tests/Kit CE

1. Quality control

The control area (C) serves as a procedural control. A colored line appears when the procedure or sample volume has been applied correctly. Control standards are not provided with this test. As Good Laboratory Practice, it is recommended that positive and negative controls be performed periodically to verify test performance.

2. Materials Supplied

- Test cassette with a pack of desiccant
- Swab
- Disposable 0.5ml extraction buffer
- Package insert

3. Clintcal Performance

The clinical performance of the Green Spring® SARS-CoV-2 Antigen Rapid Test was determined in a prospective, randomized, single-blind study. A total of 310 nasopharyngeal specimens were collected from symptomatic and asymptomatic patients within 5 days of initial symptoms. The performance of this kit was compared to the results of commercially available molecular tests. The test was found to have 98% sensitivity and 100.00% specificity. The accuracy is 99.35%.

For the anterior nasal swab method, a total of 263 specimens were collected. The test had a sensitivity of 96.8% and a specificity of 100.00%. The accuracy is 98.48%.

EU Authorized Representative: Obelis s.a.

Bd General Wahis 53, 1030 Brussels Belgium,

4. TEST PERFORMANCE

After sample collection, perform the test as follows:

1. Insert the swab sample into the extraction tube and dip it up and down in the liquid. Rotate the swab several times during this process.

2. While removing the swab squeeze the sides of the tube to extract the

remaining liquid out of the swab.

3. Place the dropper tip firmly on the extraction tube and mix the liquid thoroughly.

4. Dispense 3 drops(approximately 100μL) into the sample well of the test cassette via the dropper tip.

5. Interpret the test results after 15 minutes. Do not interpret the results after 20 minutes.

5. SARS-CoV-2 Antigen Self Test Kit Instructions

6. Storage and Stability

1. Store at 2~30ºC in the sealed pouch up to the expiration date and the validity is tentatively 12 months. Do not freeze.

2. The test cassette should be used within 1 hour after taking out from the aluminum foil bag.

3. Keep away from sunlight, moisture, and heat.

Q1: How long will it take for you to ship?
A1: Usually ships within 7 working days.

Q2: Do you support OEM/ODM?
A2: can be supported. We can customize according to your specific needs and specific quantities.

Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 certification and ISO13485 certification, so far all the production process, we have standard rules, we comply with the relevant behavior and laws of the government.

Q4: Is after-sales service guaranteed?
A4: We provide professional online technical after-sales service. If the product fails during the experiment, we can provide
one-to-one guidance through telephone, video and other forms.

Q5: What is your minimum order quantity?
A5: 1Kit.

Q6: What is the shipping method?
A6: It can be shipped by express (FEDEX, UPS, DHL, EMS, etc.) or by air and ground.Please confirm with us before placing an order.

Shenzhen Wensidun Technology Co., Ltd. was established in 2018 and is located in Longgang District, Shenzhen, Guangdong Province, China. We have in-depth cooperation with Green Spring, which has 20 years of production and R&D experience.

We have more than 2000 square meters of GMP clean production workshop and more than 1000 square meters of R&D center in Shenzhen. Products cover over 100 varieties of food safety test kits, animal diseases diagnostic kits, in vitro diagnostic reagents, genetic antibody antigen preparation and form a complete set of testing instrument.Currently,our food safety test kit and animal disease diagnostic kit are widely used in many governments,enterprises and research institutes.Our products are sold to more than 40 countries and areas.

We have ISO9001, ISO13485 quality management system certification, GMP certificate. SARS-CoV-2 Antigen Rapid Test Kit has been awarded CE certification, German BfArM approved self-test and professional test, PEI certification, EU general and mutual recognition list, and multinational white list. Ranked No. 1 in German authoritative medical magazine Daz and No. 1 in Hong Kong sales.

Enterprise mission: Caring for health and benefiting the society. Focus on products and lead the industry.

Core values: Inheriting innovation, improving quality, honesty and law-abiding, and win-win cooperation.

Our vision is to become a leading company in the biodiagnostic reagent industry, providing high-quality, convenient and reliable services to the world.