The establishment of a universal standard for both viral antigen and nucleid acid detection based on digital PCR.

ABSTRACT:

Background

Viral antigen rapid detection tests (Ag-RDTs) and PCR-based nucleic acid amplification tests (NAATs) are essential for diagnosing infections like SARS-CoV-2. However, unlike nucleic acids which can be quantified precisely in copies, viral antigens lack a standardized unit of measurement, hindering precise analytical evaluation of Ag-RDTs and comparison with NAATs.

Methods

We established a universal national standard for SARS-CoV-2 antigen and nucleic acid based on an Omicron BA.1 strain, inactivated using β-propiolactone (BPL). Its concentration was assigned via multi-laboratory digital PCR (dPCR). Clinical samples were tested with Ag-RDTs and NAATs. We also compared the impact of heat and BPL inactivation on detection using dPCR, qPCR, and sequencing. The standar

SUBMITTER: Li M 

PROVIDER: S-EPMC12523171 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature