FASTER AND COST-EFFECTIVE EXTRACTION FREE METHOD FOR SARS-COV2 DETECTION BY RT-PCR

Background: The World Health Organization (WHO) declared an outbreak of febrile respiratory illness caused by Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) in Wuhan City, China in December 2019. Within the immediate outbreak of three months, the global community was challenged with a devastating pandemic that caused heavy morbidities and mortalities around the globe. The expeditious spread of the virus, challenged the diagnostic laboratories to rapidly develop the accurate molecular diagnostic methods. As SARS CoV-2 assays became available for testing on existing molecular platforms, laboratories devoted unprecedented energy and resources to evaluating the analytical performance of the new tests and in some cases developed their diagnostic assays under FDA-EUA guidance. Aim: This study aims to compare the diagnostic efficacy of the extraction-free method of COVID-19 PCR and the conventional RT-PCR with extraction. Method: To get an accurate view of how an omission of RNA extraction step would perform in a real-world setting, a comparative study was performed using TATA MD CHECK RT-PCR DIRECT (Direct PCR) and LabGun Genomics for Conventional RT-PCR method. Result: From this study, direct RT-PCR correctly identified 92.3% of samples (n = 50) identified positive for SARS-CoV-2 RNA by conventional RT-PCR featuring an RNA extraction. Conclusion: Direct methods may represent a reasonable alternative to meet higher testing demands with low turnaround time as reverse transcription PCR includes traditionally time-consuming RNA extraction and purification procedures.