Dilution buffer reagent SafetyTector®

diagnosticlaboratoryfor immunoanalysis

SafetyTector® S is a SARS-CoV-2 inactivating extraction and dilution buffer for saliva specimens and nasopharyngeal swabs. Swabs can be extracted directly with SafetyTector® S. Samples must be diluted in SafetyTector® S at least 1:4. At this dilution, SafetyTector® S is able to inactivate SARS-CoV-2 within 1 minute. Therefore the samples are no longer infective. SafetyTector® S eliminates the high risk of infection during and after testing coming from the specimen or other test materials. Virus inactivation was confirmed and tested with infectious viruses in a Biosafety Level 3 laboratory. Saliva samples spiked with SARS-CoV-2 were mixed 1:4 with PBS or CANDOR‘s SafetyTector® S and incubated for the indicated times at room temperature. After incubation, samples were titrated and added on Vero E6 cells. After 5 to 7 days, infectivity was determined according to the Reed-Muench-method. Already after 1 min of incubation with SafetyTector® S, no remaining infectivity was detectable with this assay. Samples diluted in SafetyTector® S can directly be used in lateral flow assays and also in other immunoassays such as ELISA, protein arrays or bead-based assays. Why should I use SafetyTector® S? Safe Design of in vitro diagnostic medical devices (IVD products) is an obligatory pre-requisite for placing them on the international markets in the EU. This is defined in EU legislation (Directive 98/79/EG, Annex I, chapter B, clause 2.1 and Regulation (EU) 2017/746, Annex I, Chapter I, clause 4). Besides that, the ISO 14971 „application of risk management to medical devices“ (ISO 14971:2012, Annex A,