ABSTRACT
Background: Real time reverse transcriptase polymerase chain reaction (RT-PCR) on clinical specimens is considered the first line test for the diagnosis of SARS-CoV-2 infection. This test involves different steps: RNA extraction, reverse trancription, PCR setting-up, amplification and analysis of results. To date, several analyzers for extraction and amplification phases are availabe, while few are able to guarantee the automation of the entire workflow. To optimise the allocation of swabs, with the aim of maximising the number of swabs tested and reducing the wait time for results, we applied a decentralysed system.Methods: In Provincia of Modena a network of 5 suburban laboratories referring to central laboratory was developed.The work was focused not only on the implementation of new analyzers, but also on the organization and consolidation of the whole workflow integrating the pre-analytical, analytical and postanalytical phases and including the molecular biology tests report on LIS (Laboratory Information System). Furthermore, all laboratory professionals attended a specific training.Results: Between march 2020 and June 2021 450,000 RT-PCR for RNA of Sars-Cov-2 research were performed. The central laboratory analyzes the majority of swabs (n= 259832, 58%), including those enrolled at drive through (44%). 76% were analyzed with a automated system, and 24% with a manual procedure. The laboratory is open every day including Sunday, from 8:00 a.m. to 8:00 p.m. engaging two biologists and five laboratory technicians per day. Our project allowed to increase significantly the number of swabs tested in a day (from 100 in march 2020 to 4600 in march 2021), guaranteeing their reporting within 3 hours in emergency or 24 hours for routine and drive setting.Conclusions: The employ of automated, user friendly and with a guided interface instrument facilited the entire workflow, reducing the operator work and the reporting time. RT-PCR executed with a manual procedure need of a specific expertise to read the reaction products, but the shorter reporting time makes it useful for swabs made in emergency. However, the presence of the barcode reader and the connectivity with the management LIS facilitated the traceability of the samples for the entire diagnostic pathway and the minimization of human error. The implementation of our workflow has involved an important rationalization and optimization of the staff, while integration of new knowledge about SARSCOV-2 and optimal analytical performance of analyzers has allowed a modern management of the samples maximising the laboratory's test capacity for RT-PCR tests.