Sensitive amplified luminescent proximity homogeneous assay for the quantitative detection of growth differentiation factor 15 and its application in cardiovascular disease.

OBJECTIVE

This study aimed to develop a rapid, high-sensitive, and accurate amplified luminescent proximity homogeneous assay (AlphaLISA) for measuring plasma concentrations of growth differentiation factor 15 (GDF15) and assessing its application value in the diagnosis of cardiovascular disease (CVD).

METHODS

Based on the AlphaLISA method, plasma GDF15 levels were quantified in healthy controls (HCs), heart failure (HF), and myocardial infarction (MI) patients using a double-antibody sandwich format. The diagnostic efficiency of GDF15 for HF and MI was assessed by ROC curve analysis.

RESULTS

The established GDF15-AlphaLISA took only 15 minutes with good linearity (R2 >0.99) and wide detection range (0.072 ~ 200 ng/mL). The intra- and inter-analytical precision were within 10%, and the recovery rate was 96.06% ~109.41%. There was no significant cross-reactivity with CVD biomarkers (Galectin-3, ST2, cTnI) or with other TGF-β superfamily members (TGF-β1, GDF8, BMP2, BMP6). Results showed that GDF15 could significantly distinguish HCs and patients (p < 0.0001), and ROC curve showed that GDF15 had a high diagnostic efficiency for HF and MI (AUC >0.95).

CONCLUSION

We have successfully established a sensitive and rapid GDF15-AlphaLISA method, which can promote the timely diagnosis of HF and MI, and it is a good auxiliary means for the initial diagnosis of HF and MI.