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

SARS-CoV-2 Ag Rapid Test Kit Colloidal Gold 10 Tests/Kit CE Results in 15 min

1. Summary

The novel coronaviruses belong to a β genus. COVID-19 is an acute respiratory infectious disease. Humans are generally susceptible to it. Currently, patients infected with novel coronavirus are the main source of infection; asymptomatic infected people may also be a source of infection. The main manifestations include fever, fatigue, and dry cough. A stuffy or runny nose, sore throat, muscle aches, and diarrhea occur in a few cases.

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 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. 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.