The BioSURE® COVID-19 IgG Antibody Self Test is housed in a novel barrel device, as utilised in the BioSURE HIV Self Test and is a single-use in Vitro diagnostic test for the qualitative detection of COVID-19 (SARS-CoV-2) neutralising IgG antibodies in a human finger prick whole capillary blood, by an untrained end-user.
All the components needed are included in each test kit and the test does not require any manual mixing or measuring, as the correct blood volume is automatically drawn into the tip of the barrel testing device. No additional equipment is needed, it is proven to be simple to perform and gives an easy to read, binary result of one line (negative) or two lines (positive) in 20 minutes. 3 simple steps – No COVID-19 antibody test is easier
Sensitivity – 98.2% (CI: 96.4-99.2%)
Specificity – 99.7% (CI: 99.1-99.99%)
This test is CE marked for use in Europe. The BioSURE® COVID-19 IgG Antibody Self Test was developed and is manufactured in its entirety in the UK.
Each box contains –
1 x BioSURE COVID-19 IgG Antibody Self Test Pouch containing
1 x BioSURE COVID-19 IgG Antibody test device
1 x single-use safety lancet
1 x plaster
1 x Instructions for Use, including integrated tray for reading results