Call for Tenders SANTE/2020/C3/064 for the Supply of Rapid Antigen Tests for Diagnostic of COVID-19

Description

The purpose of the procedure is to obtain a supply of rapid antigen tests for the contracting authorities. For that aim, the framework supply contracts in cascade are concluded with the successful tenderers. Antigen tests are immunoassays that detect the presence of a specific viral antigen, which implies current viral infection. Antigen tests are currently authorised to be performed on nasopharyngeal or nasal swab specimens placed directly into the assay’s extraction buffer or reagent. Rapid antigen tests do not replace the RT-PCR for clinical diagnostic, but are complementary, particularly when used for the screening of persons who are asymptomatic and do not have a known exposure to SARS-CoV-2. A positive rapid-antigen-test should always be confirmed by RT-PCR. Lot 1: RAT-1 (Visual, very High Sensitivity and Specificity, WHO/EU) Rapid antigen test kit 1: visual read; sensitivity: very high (>/= 96 %) compared to RT-PCR; specificity: very high (>/=97%) compared to RT-PCR; WHO/emergency use list (or application ongoing). Lot 2: RAT-2 (Visual Read, very High Sensitivity and Specificity) Rapid antigen test kit 2: visual read; sensitivity: very high (>/= 96 %) compared to RT-PCR; specificity: very high (>/=97%) compared to RT-PCR. Lot 3: RAT-3 (Visual Read, High Sensitivity and Specificity) Rapid antigen test kit 3: visual read; sensitivity: high (>/= 90 %) compared to RT-PCR; specificity: very high (>/=96%) compared to RT-PCR. Lot 4: 4.1 Rapid Antigen Test Kit 4 (Device Read, High Sensitivity and Specificity) and 4.2 Reading Device for Rapid Antigen Test Kits Rapid antigen test kit 4 (device read; Sensitivity: high (>/=90%) compared to RT-PCR; specificity: very high (>/=99%) compared to RT-PC) and a compatible reading device.