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5 Tests/Kit SARS-CoV-2 Antigen Self Test Kit CE For Nasal Swab Sensitivity 98.84%

Shenzhen Wensidun Technology Co., Ltd.
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Shenzhen Wensidun Technology Co., Ltd.

5 Tests/Kit SARS-CoV-2 Antigen Self Test Kit CE For Nasal Swab Sensitivity 98.84%

City & Province shenzhen
Categories Cotton Pad
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Product Details

SARS-CoV-2 Antigen Self Test Kit 5 Tests/Kit CE for Nasal Swab Sensitivity 98.84%

 

Summary

 

COVID-19 is an acute respiratory infectious disease caused by the novel coronavirus SARS-CoV-2. Humans are generally susceptible to it. At present, patients infected with the new coronavirus are the main source of infection; asymptomatic infections may also be the source of infection. Symptoms include fever, fatigue, loss of smell and/or taste, and dry cough. In some cases, symptoms may include a stuffy or runny nose, sore throat, muscle aches, and diarrhea.

 

Materials Provided

 

ComponentDescriptionSpecification
5 test/kit
Test cassetteFoil ouched test device containing one reactive strip.5
Sterile swabFor sample collection and transfer.5
Inside pageInstructions for use.1
Extraction bufferDissolve the sample5
The certificate of conformity 1
Packages with holesBe used as tube stand (optional).1

 

Performance data


For the anterior nasal swab method, 645 specimens were collected.

 

 Vitassay qPCR SARS-CoV-2

Total

PositiveNegative

SARS-CoV-2 Antigen Rapid Test kit

Positive2380238
Negative7400407
Total245400645

 

StatisticValue95% CI
Sensitivity97.14%94.20% to 98.84%
Specificity99.99%99.08% to 100%
Total coincidence rate98.91%97.78% to 99.56%
 

Positive Test Result


If a colored line is visible in the test line region (T) and a colored line is visible in the control line region (C), indicating positive test result. This means that SARS CoV-2 antigens are detectable in your nasal sample and indicates with high probability of COVID-19 infection.

 

 

Please stay home and call your doctor or local health department. Follow local self-isolation guidelines and take a PCR confirmation test.
* Note: Line thickness is irrelevant; any reddish lines in the test line (T) should be interpreted as a positive test result. Positive test results must be confirmed by molecular diagnostics such as PCR testing.


Negative test result


If only colored lines are visible in the area of the control line (C), but not at the test line (T), the test result is negative. This suggests that the nasal samples were either absent or too little of the SARS-CoV-2 antigen and probably not infected with the SARS-CoV-2 virus.

 

 

Continue to follow applicable rules regarding contact with others and applicable protective measures. In case of suspicion, repeat the test using new test kit, as SARS-CoV-2 virus cannot be accurately detected at all stages of infection. A negative result does not rule out infection with SARS CoV-2 and should be confirmed by PCR testing if suspected.

 

INVALID TEST RESULT


If no line is visible in the control line (C) or only one line is visible in the test line area (T), indicating the test is not performed correctly and the result is invalid. It is important to follow the instructions for the test carefully. Please repeat the test with new sample and new test set.

 

 

If test results remain invalid, please contact a physician or COVID-19 testing center.

 

Interpretation of test results


Check that the wire is visible at the control wire (C). The color thickness of the control line (C) does not matter. If it is not visible, the test was not executed correctly and a new test must be executed with the new test set.

 

Storage and disposal


Store at room temperature (2-30°C or 35.6-86 T).
Shelf life 12 months (from production date to expiration date).
Test cassettes must be stored in airtight foil pouches until use. Do not use after expiration date.
Waste from used tests should be disposed of according to local regulations.

 

 

 

 

Q1: When will it be shipped?
A1: We will ship the goods for you as soon as possible within 7 working days after receiving the payment. (In the event of the epidemic and other external factors, there may be delays in shipping)

 

Q2: Does it support OEM/ODM?
A2: It can be supported, but the specific quantity needs to be more than 100,000 pieces to facilitate customized products.

 

Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 and ISO13485 certified by the state. Our production process is in accordance with the standard process, which can ensure that the quality of the products is optimal.

 

Q4: How is after-sales service provided?
A4: We provide professional online technical after-sales service. We can provide you with one-on-one guidance in the form of video, phone calls, etc.

 

Q5: What is the payment method?
A5: We receive payment by T/T.

 

Q6: How to ship?
A6: By obtaining quotations from our many cooperative carriers, choose the best way to ship for you, or you can ship according to your requirements.

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