As a building block for ensuring operational and personnel capacity during active ingredient production of our customers, 4base lab started early on an internal employee protection program utilizing a daily SARS-CoV-2 testing schedule. As a prerequisite for this program, 4base lab has cloned a recombinant SARS-CoV-2 RNA standard being used in SARS-CoV-2 diagnostics both as a positive control and as a quantitative RNA standard. It enables monitoring correct test performance and/or to quantify RNA copies in patient samples.

Meanwhile, the demand for laboratory tests for the detection of coronavirus is steadily increasing, leading to bottlenecks in various supply chains. Therefore, alternative kits or replacements to the standard procedures are highly desirable for which a non-infectious reference material is especially helpful. The lack of control material is currently one of the biggest challenges for laboratories. Since positive viral material can only be used under BSL3 for reasons of biological safety, 4base lab has developed its synthetic RNA (4BLqSARS-CoV-2-RNA) encompassing all common primer-probe binding sites for RT-PCR for the detection of SARS-CoV-2 encoding the envelope- and RdRP gene (Berlin Charité) as well as those of the American CDC for the nucleocapsid phosphoprotein (N1, N2, N3).

4base lab AG has further developed its SARS-CoV-2 Real-Time RT-PCR Assay to a commercial available kit together with Mediagnost GmbH.