Validation of a 2-Gene Blood Test for Kawasaki Disease in Febrile Children - PubMed
3 hours ago
- #Pediatrics
- #Diagnostic test
- #Kawasaki disease
- A 2-gene whole-blood qPCR assay measuring IFI27 and MCEMP1 expression was validated to distinguish Kawasaki disease (KD) from other pediatric febrile illnesses.
- The diagnostic study involved 541 children (ages <8 years) including 243 with KD and 298 febrile controls, achieving an AUC of 0.91, sensitivity of 94%, and specificity of 82%.
- The assay showed consistent performance across diverse groups, such as incomplete KD and various febrile etiologies, and demonstrated high analytical validity with linearity (R² >0.99) and precision (CV <5%).
- Blood samples were stable for up to 6 days at 4°C or 24 hours at room temperature, and the test was developed as a laboratory-developed test.
- Prospective evaluation in broader populations is needed to assess clinical utility for reducing diagnostic delays and preventing coronary artery complications.