Comparing clinical utility of STANDARD M10 rapid rtRT-PCR assay with pooled testing for SARS-CoV-2 screening

Abstract

Pre-admission screening for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was essential during the COVID-19 pandemic in Korea. The pooled real-time reverse transcription (rtRT)-PCR test, recommended for optimizing testing capacity, had long turnaround times, limiting its use for same-day hospitalizations. This study evaluated the performance and clinical utility of a rapid rtRT-PCR test as an alternative screening tool for same-day admissions, compared to pooled testing with standard rtRT-PCR. Between July 2022 and January 2023, nasopharyngeal and oropharyngeal swabs were collected twice from each of 3931 patients. Samples were tested using the STANDARD M10 SARS-CoV-2 rapid rtRT-PCR assay and the pooled Allplex SARS-CoV-2 assay. The SARS-CoV-2 positivity rates were 2.4% (n = 96) for the STANDARD M10 and 2.6% (n = 104) for pooled testing, with an overall agreement of 97.3%. The mean turnaround time for the STANDARD M10 was 2.1 h; with 90% of results reported within 2.9 h, compared to 10.7 and 17.1 h for pooled screening-negative and individual test cases, respectively. The STANDARD M10 assay demonstrated high concordance with pooled testing, offering a simple procedure and rapid reporting, making it suitable for same-day admission screening. Rapid rtRT-PCR was crucial for healthcare system resilience during COVID-19 pandemic and will be essential for future preparedness.