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SARS-CoV-2 Antigen Rapid Test Self- Testing 98.8% Accuracy

HUBEI SAFETY PROTECTIVE PRODUCTS CO.,LTD(WUHAN BRANCH)

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Address: No. 13 Huashiyuan North Road,Wuhan East Lake High-tech Development Zone, Hubei,China

Contact name:Melody Xu

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HUBEI SAFETY PROTECTIVE PRODUCTS CO.,LTD(WUHAN BRANCH)

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SARS-CoV-2 Antigen Rapid Test Self- Testing 98.8% Accuracy

Country/Region china
City & Province wuhan hubei
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Product Details

SARS-CoV-2 Antigen Rapid Test (Self- Testing)

 

SARS-CoV-2 Antigen Rapid Test is a lateral chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal or nasopharyngeal swab speciments directly from individuals who are suspected of COVID-19 by theire healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test can also test specimens from asymptomatic individuals.

 

This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years older. The Antigen Home Test does not require serial testing.

 

  • Anterior nasal swab speciment
  • Results 15 minutes
  • 12 Months shelf life
  • Store between 36 to 86° F
  • Sample self-collection ages 14 and older
  • Sample collection by an adult in Children ages 2 to 13
  • Excellent performance when compared to an FDA  authorized molecular SARS-CoV-2 test.

 

 

Clinical Performance

 

Nasal Swab Specimens

The performance of SARS-CoV-2 Antigen Rapid Test was established with 605 nasal swabs collected from individual symptomatic patients who were suspected of COVID-19. The results show that the relative sensitivity and the relative specificity are as follows:

 

 

Materials Provided

  • Test Cassette(s)
  • Extraction Buffer Tube(s)
  • Package Insert
  • Nasal Swab(s)
  • External Tube Holder -  Package of 25 tests

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