Search

Background. qRT-PCR investigations on patient specimen seem to be the only probable laboratory technology to validate the current individual SARS-CoV-2 status correctly. This kind of nucleic acid amplification technology is available in most countries, but missing in resource limited areas with poor laboratory infrastructure. The most feasible way to build up PCR test capacities for SARS-CoV-2 in these areas is the use of conventional PCR. PCR-thermocycler and gel-electrophoresis systems could be shipped easily by parcel service to the whole world, because they are almost maintenance free and need no engineers for their installation and service. Methods. In order to reduce the complexity of sensitive reagent kits we have developed a freeze dried test kit for the traditional RT-PCR for the detection of SARS-CoV-2 in single ready to use tubes. Transport and storage of the reagents are now free of any cooling chain.Results. We have analysed 244 patient samples and compared the results to the SEEGENE Allplex™ 2019-nCoV assay. The sensitivity and specificity were 95.5% and 98.5%, respectively. Next to these performance parameters we could implement a workflow for processing 96 patient samples in parallel, handled by only 1 laboratory technician in an 8 hours working day.Conclusion. The use of conventional PCR in combination with gel-electrophoresis for test analysis is a feasible approach to make SARS-CoV-2 diagnostic available in the whole world. This is needed urgently, because SARS-CoV-2 is a question of global health and not only of the well-equipped countries.