ArticleVirology journal2025
The establishment of a universal standard for both viral antigen and nucleid acid detection based on digital PCR.
Article in Virology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Development and Validation of a Triplex RT-qPCR Assay for Rapid Clinical Diagnosis and Serotyping of Feline Infectious Peritonitis Virus.International journal of molecular sciences · 2026Article
- Development of PMAxx-droplet digital PCR method for the absolute quantification of viableFrontiers in microbiology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundViral 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.
methodsWe 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 standard was then used to evaluate the limits of detection (LoDs) of commercial Ag-RDTs and NAATs using a common unitage.
resultsClinical samples' results showed that antigen positivity was correlated with higher nucleic acid titers. Both BPL inactivation and heat inactivation maintained comparable nucleic acid titers, but BPL inactivation preserved better antigen activity. The national standard concentration was assigned as 1.04 × 10
conclusionWe established and validated a BPL-inactivated universal national standard specifically designed to overcome the difficulties in quantifying antigen and enabling direct sensitivity comparison between SARS-CoV-2 Ag-RDTs and NAATs.
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Registered trials
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