ANTIGEN PRODUCT INFORMATION
FOR PROFESSIONAL USE ONLY / WORKPLACE TESTING SOLUTION
Antigen Test. Not only is it entirely UK developed and manufactured, it is an easy to use saliva test.
Both Liverpool School of Tropical Medicine and St Georges’ University of London and other leading laboratories across the world have been part of the team to iterate, improve and validate the BioSURE COVID-19 Antibody tests
The range of tests BioSure manufacture and supply are used worldwide for the management of human infectious disease, those include, Syphilis, Hepatitis B, Hepatitis C and Malaria testing kits.
The test is a single use in Vitro diagnostic test for the qualitative detection of COVID-19 and give results in 15 minutes.
Sensitivity is not the correct terminology for antigen testing, especially for testing in the field – what you really need to know is the Level of Detection (LoD) as this tells you how many antigens there needs to be in a sample for the test to be able to detect them and give a positive result.
Independent data evidences our test can detect down to 500 pfu/ml, which basically means it should show a positive result for someone with virus the day before they become infectious to someone else.
Specificity – >99.9% (CI: ) (specificity means the number of times the test will correctly identify true negatives, ie no false positives) Independent data evidences our test has not produced any false positives across hundreds of samples, however 100% is not something we would claim.
This test will be CE marked for Professional Use Only, registered with the MHRA and available at the end of January 2021. Pre orders now being taken
Each box contains –
25 oral swabs individually packaged
25 buffer solution tubes
1 Product Insert
BioSURE COVID-19 Antigen Professional Test
8° – 30°
2° – 30°