Request Info Case Studies News & Events Careers Investors Knowledge Center België COVID-19 SARS-CoV-2 Antibody Test The LumiraDx SARS-CoV-2 Ab Test is a microfluidic immunofluorescence assay for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (capillary fingerstick or venous), plasma or serum for indication of recent or prior infection. Used with the LumiraDx Platform the Test delivers rapid results at the point of care. EXPLORE ANTIGEN TEST Test benefits The LumiraDx SARS-CoV-2 Ab Test is designed to be used in community care settings to identify individuals with an adaptive immune response to COVID-19, indicating recent or prior infection. Easy to implement in point of care settings Clinical agreement (direct fingerstick) in samples collected more than 8 days post RT-PCR 100% (62/62) positive agreement 100% (54/54) negative agreement Time to result in 11 minutes Test procedure The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test are functioning correctly for every test run. The workflow process is comprised of a simple sample collection with a fingerstick lancet followed by step-by-step guidance of the Instrument to report a patient result in 11 minutes from sample application. Test performance Fingerstick sample performance In clinical studies, fingerstick samples showed 100% positive agreement and 100% negative agreement when collected more than 8 days post RT-PCR. Positive agreement Negative agreement Direct fingerstick 100% (62/62) 100% (54/54) Fingerstick via transfer tube 100% (62/62) 100% (56/56) Plasma sample performance In clinical studies, plasma samples demonstrated an overall 97.2% positive agreement and 100% negative agreement when compared to RT-PCR. Positive agreement Days from RT-PCR to blood collection Number of sample Sensitivity RT-PCR comparator ≤ 6 days 13 84.6 % 7-13 days 7 100 % 14-20 days 6 100 % ≥ 21 days 46 100 % Total 72 97.2 % (90.4 % - 99.2 %) For more information about the LumiraDx SARS-CoV-2 Ab Test SARS-CoV-2 Antibody (Ab) Product Insert SARS-CoV-2 Antibody (Ab) Test Specifications SARS-CoV-2 Antibody (Ab) QC Product Insert SARS-CoV-2 Antibody (Ab) Quick Reference Instructions Safety Data Sheet Technical Bulletin Platform Disinfection Procedure How to run an Antibody Test Video INQUIRE COMPLIANCE DOCUMENTS Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets. Who we are Request Info Case Studies News & Events Careers Investors Instrument Test Menu Connectivity Testing in Action Customer Services Fast Lab Solutions Facebook LinkedIn Twitter Legal Information UK Addresses © 2021 LumiraDx. All rights reserved, worldwide. Registration Number: 09206123. Over Cookies op deze website We gebruiken cookies om uw ervaring op onze website te personaliseren en te verbeteren. Bezoek onze Privacyverklaring voor meer informatie over persoonlijke voorkeuren of om deze te beheren in onze Tool Voor Cookietoestemming. Door onze website te gebruiken, gaat u ermee akkoord dat we cookies gebruiken. Accepteren Cookies beheren