Alliance for Pandemic Preparedness

April 9, 2021

Ultra-Sensitive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection for the Diagnosis of Coronavirus Disease 2019 (COVID-19) in Upper Respiratory Samples

Category:

Topic:

Keywords (Tags):

  • A study of a newly developed ultra-sensitive assay for detection of SARS-CoV-2 (S-PLEX, MesoScale Diagnostics) in upper respiratory samples (N=450) with a cycle threshold <35 (higher concentration of virus) demonstrated 95-98% positive agreement and 93-96% negative agreement with RT-PCR. This study confirmed the findings of a previous study of the assay that was performed on frozen, stored samples. Advantages of S-PLEX include the ability to perform high-throughput testing, which can expedite testing in high-volume or surge settings, and provides another option for sensitive testing in settings where molecular testing supplies are scarce. However, the relatively lower negative agreement with RT-PCR suggests confirmatory testing may be required for samples with low-positive antigen levels. 

Wang et al. (Apr 8, 2021). Ultra-Sensitive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection for the Diagnosis of Coronavirus Disease 2019 (COVID-19) in Upper Respiratory Samples. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciab063