CE SARS-CoV-2 Antigen Rapid Test Self Test Colloidal Gold 10Tests/Kit 15 Min Test Kit

SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold) 10Tests/Kit CE Results in 15 minutes

1. Intended Use

The Green Spring ® SARS-CoV-2 Antigen Rapid Test is for the rapid qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human nasal or nasopharyngeal swab specimens. The results are used for the detection of SARS-CoV-2 antigens. The antigen is generally detectable in upper respiratory tract specimens during the acute phase of infections. Positive results do not rule out bacterial infection or co-infection with other viruses. The pathogen detected may not be the sole cause of the disease. Negative results should be considered in the context of a patient's recent exposures, history, and presence of clinical signs and symptoms consistent with COVID-19. Suspective cases should be confirmed with a molecular assay. Professional use only.

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 prospective,randomized, single-blind studies. A total of 310 nasopharyngeal specimens from symptomatic and asymptomatic patients were collected within 5 days of the onset of initial symptoms. The performance of the kit was compared with the results of a commercially available molecular test. The test was found to have a sensitivity of 98% and a specificity of 100.00%. The accuracy is 99.35%.

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

EU Authorized Representative: Obelis s.a.

Bd General Wahis 53, 1030 Brussels Belgium,

4. Test Principle

The Green Spring ® SARS-CoV-2 Antigen Rapid Test is a qualitative, membrane-based immunoassay for the detection of nucleocapsid protein antigens of SARS-CoV-2, The test line region is coated with a SARS-CoV-2 antibody. The sample reacts with the SARS-CoV-2 antibody in the test line region. If the specimen contains SARS-CoV-2 antigensa colored line appears in the test line region (T) as result. As a procedural control, a colored line appears in the control line area(C) indicating that the correct volume of sample has been added and membrane wicking has occurred correctly.

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

6. SARS-CoV-2 Antigen Self Test Kit CE certificate

7. Storage and Stability

Store the tests in the sealed foil pouch at room temperature or refrigerated (2 -30 "C). The test is stable until the expiry date. The test cassettes should be kept in the sealed foil pouch until use. Do not freeze. Do not use after expiration date. Keep away from sun, 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.