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

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

Model NO.
IRSJ-02
Price:
€ 35.00-50.00 / box
Delivery:
FOB
Quantity:

Product Name: Flowflex IVROU SARS-CoV-2 Antigen Rapid Test(Self-Testing)

Package and Specification:

L031-11855: 1 Test/Kit, 20Kits/Box

L031-118A5: 5 Test/Kit

Intended Use: The Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. The Flowflex SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.

Objective: A multi-site clinical study was conducted in China and USA to evaluate the performance of the Flowflex SARS-CoV-2 Antigen Rapid Test when compared to RT-PCR method.

Study AcceptanceCriteria: Total Sensitivity≥85%, Total Specificity≥98%

Study Conclusions: Using a total of 605 specimens tested at multiple sites in U.S and China, the Flowflex SARS-CoV-2 Antigen Rapid Test has sensitivity of 97.1%, specificity of 99.5%, and accuracy of 98.8% when comparing with FDA EUA RT-PCR.

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