Shenzhen Wensidun Technology Co., Ltd.
                                                                                                           
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15 Min SARS-CoV-2 Ag Antigen Self Test Kit Colloidal Gold 10 Tests/Kit CE

Price Negotiable
Price: Negotiable
MOQ: 1kit
Delivery Time: 7~14days
Brand: Green Spring
Product Description

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.

Get in Touch

Have questions about our products or want to discuss a custom order? Our team is ready to help you.

Company Shenzhen Wensidun Technology Co., Ltd.
Location Vanke Tianyu Garden,B2-1010, Unit B, Building 9 Longcheng Street Longgang District Shenzhen, China
Contact Person Zhang

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