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%.
| Greenspring SARS-COV2-Antigen-rapidtest (nasopharyngeal) | PCR-Comparator | Total |
| Positive | Negative | |
| Positive | 98 | 0 | 98 |
| Negative | 2 | 210 | 212 |
| Total | 100 | 210 | 310 |
| Sensitivity | 98% (95% Cl: 97,12-99,98%) |
| Specificity | 100% (95% Cl: 98,12-99,99%) |
| Accuracy | 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%.
| Greenspring SARS- COV2-Antigen-rapidtest (anterior nasal) | PCR-Comparator | Total |
| Positive | Negative | |
| Positive | 121 | 0 | 121 |
| Negative | 4 | 138 | 142 |
| Total | 125 | 138 | 263 |
| Sensitivity | 96,8% (95% Cl: 91,52-98,97%) |
| Specificity | 100% (95% Cl: 96,62-100%) |
| Accuracy | 98,48% (95% Cl: 96,17-100%) |
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.
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