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CE marked SARS-CoV-2 total antibody rapid test

The Wantai CE marked SARS-CoV-2 total antibody rapid test from Beijing Wantai Biological Pharmacy is for the screening of patients suspected for infection with the SARS-CoV-2 virus, or as an aid in the diagnosis of the COVID-19 disease. This kit is based on the double antigen "sandwich" method and  detects total antibodies against S1-RBD.SARS-CoV-2 Ab Rapid Test

The kit can be used to:
• Indicate an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection
• Detect seroconversion in patients following known recent SARS-CoV-2 infection
• Aid in the diagnosis of acute or past SARS-CoV-2 infection in conjunction with other tests and clinical information

Features of the SARS-CoV-2 total antibody rapid test
• Lateral low test - suitable for rapid, on-site testing
• Fast - clear answer within only 15 minutes
• High performance -  sensitivity of 94.70% (125/132) and specificity of 98.89% (268/271)
• Easy-to-use - no special equipment
• Wide sample compatibility - whole blood, serum or plasma samples

Kit evaluation
• RIVM National Institute for Public Health (Netherlands) and Czech Republic Ministry of Health
In a limited validation, the RIVM National Institute for Public Health in the Netherlands, and the Ministry of Health in the Czech Republic both reported kit sensitivity and specificity of 100%
• Medizinische Universität Wien
The Medizinische Universität Wien in Austria calculated a kit sensitivity of 80% (6-10 days) and 100% (>11 days) respectively
University of Innsbruck
The University of Innsbruck reported a kit sensitivity of 95.7% (100% >14 days) and specificity of 100%.
• French National Reference Center
The French National Reference Center (CNR) in France evaluated the kit and conclude that it has a sensitivity of 89% (7-13 days), 92% (14-19 days) and 94% (>20 days) respectively.
• National Cancer Institute (NCI USA)
A validation study conducted by the National Cancer Institute (NCI) in the USA showed a kit sensitivity of 100% (30/30) and specificity of 98.8% (79/80) of the test. Subsequently, WANTAI SARS-CoV-2 Ab Rapid Test received FDA Emergency Use Authorization on July 10 2020

UK Government COVID-19 testing guidance
The UK Government’s guidance regarding the use of the COVID-19 diagnostic assays can be found here

The test should not be used as the sole basis for diagnosis.

Products

Note: product availability depends on country - see product detail page.

Details Cat number & supplier Size Price
SARS-CoV-2 Total Ab Rapid Test (CE-IVD) WJ-2750 · Beijing Wantai Biological Pharmacy
WJ-2750
Beijing Wantai Biological Pharmacy
50 tests POA
50 tests
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