Assessment of Commercial Lateral Flow Immunoassays for Rubella IgM Detection in Serum Samples
International Journal of Infectious Diseases·
- DOI
- 10.1016/j.ijid.2026.109057
- PMID
- 42604651
- PMCID
- —
- OpenAlex
- W7203572948
- Study type
- Journal article
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
These rapid platforms could enable decentralized screening in regions lacking advanced laboratory infrastructure, provided that positive outcomes undergo confirmatory testing.
Structured evidence summary
Research question
The study investigates the diagnostic performance of commercially available lateral flow immunoassays for detecting rubella-specific IgM antibodies.
Study design
An in vitro comparative evaluation was conducted using a standardized serum panel alongside two established enzyme immunoassays as reference standards.
Population and setting
The analysis utilized a controlled laboratory serum panel comprising diluted controls and pooled samples rather than a clinical patient cohort.
Main findings
The majority of evaluated rapid tests demonstrated markedly reduced analytical sensitivity compared to reference methods, identifying target antibodies only at elevated concentrations. A small subset exhibited increased sensitivity alongside compromised specificity. Elevated rubella IgG titers did not produce cross-reactive interference.
Public-health relevance
These rapid platforms could enable decentralized screening in regions lacking advanced laboratory infrastructure, provided that positive outcomes undergo confirmatory testing.
Important limitations
Diagnostic accuracy was assessed using a fixed serum panel rather than a diverse array of clinical specimens collected from actual patient populations.
GIDS interpretation
This publication supplies technical context for evaluating point-of-care diagnostic tools within rubella monitoring frameworks, highlighting how performance trade-offs may influence deployment decisions in resource-constrained environments.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 12 auditable classifier relationships to diseases, places, topics, and study design.