Usefulness of the extraction-free RT-PCR methods for the SARS-CoV-2 diagnostics: An Italian experience

Abstract The extraction-based real-time reverse transcription polymerase chain reaction (RT-PCR) is currently the “gold standard” for the SARS-CoV-2 diagnostics. However, some extraction-free RT-PCR techniques have been recently developed. In this study we compared the performance of heated and unheated extraction-free methods with the traditional extraction-based SARS-CoV-2 RT-PCR. The unheated extraction-free showed a perfect agreement with the standard extraction-based RT-PCR. By contrast, the heat-treated technique was associated with an 8.2% false negativity rate. The unheated extraction-free RT-PCR for the SARS-CoV-2 molecular diagnostics is a valuable alternative to the traditional extraction-based methods and may accelerate turnaround times by about two hours.