Validation of a 2-Gene Blood Test for Kawasaki Disease in Febrile Children
Authors' conclusion
This diagnostic study found that a 2-gene laboratory-developed whole-blood qPCR assay measuring IFI27 and MCEMP1 expression accurately distinguished KD from other febrile illnesses using standard molecular platforms.
Study context
- Population
- Children younger than 8 years with kawasaki disease (KD) and febrile controls with viral, bacterial or mixed infections, Taiwan and Shanghai, China243 KD, 298 febrile controls
- Participants
- 541 participants
- Comparison
- 2-gene whole-blood quantitative polymerase chain reaction (qPCR) assay (IFI27 and MCEMP1) for KD vs other paediatric febrile illnesses
- KD scoren = 541
- Outcome
- Diagnostic accuracy of the prespecified 2-gene KD score (AUC, sensitivity, specificity, predictive values, likelihood ratios)
Methodological detailsmulticentre, prospective sample collection, retrospective analysis, prespecified 2-gene KD score, Implemented as a laboratory-developed test
- Multicentre
- Prospective sample collection, retrospective analysis
- Prespecified 2-gene KD score
- Implemented as a laboratory-developed test
Performance
As reported in the abstract
Discrimination of KD from febrile controls
| Test or model | AUC | Sensitivity | Specificity | Positive likelihood ratio | Negative likelihood ratio |
|---|---|---|---|---|---|
| KD score | 0.91 (95% CI, 0.88-0.94) | 94% (95% CI, 93%-97%) | 82% (95% CI, 78%-86%) | 5.12 | 0.05 |
KD score
AUC0.91 (95% CI, 0.88-0.94)
Sensitivity94% (95% CI, 93%-97%)
Specificity82% (95% CI, 78%-86%)
Positive likelihood ratio5.12
Negative likelihood ratio0.05
Further findings
Performance across subgroups (incomplete KD, diverse FC etiologies, coronary artery phenotypes)
- Performance was consistent across cohorts
Analytical validation
- Linearity R2
- > 0.99
- Precision, coefficient of variation
- <5%
- Sample stability
- up to 6 days at 4 °C or 24 hours at room temperature
Original publication
Validation of a 2-Gene Blood Test for Kawasaki Disease in Febrile Children. JAMA Netw Open. Published 1 May 2026. doi:10.
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