Key result
The AFIAS ST2 and ichroma ST2 point-of-care assays demonstrated high correlation (r = 0.82 and 0.81, respectively) with the Presage ST2 assay and equivalent performance in predicting cardiovascular death.
Why the study?
Elevated sST2 levels may predict mortality in HF patients, prompting evaluation of the performance of two newly developed POC sST2 assays compared with the Presage ST2 assay.
Do the AFIAS ST2 and ichroma ST2 point-of-care assays perform equivalently to the Presage ST2 assay in measuring sST2 levels and predicting cardiovascular death in heart failure patients?
Observational (n=878)
Yes
Do the AFIAS ST2 and ichroma ST2 point-of-care assays perform equivalently to the Presage ST2 assay in measuring sST2 levels and predicting cardiovascular death in heart failure patients?
The new point-of-care assays AFIAS ST2 and ichroma ST2 perform equivalently to the established Presage ST2 assay for measuring sST2 and predicting cardiovascular death in heart failure patients.
Background: Elevated soluble suppression of tumorigenicity 2 (sST2) levels may predict mortality in heart failure (HF) patients. The AFIAS ST2 assay (AFIAS ST2, Boditech Med Inc., Chuncheon, Korea) and ichroma ST2 assay (ichroma ST2, Boditech Med Inc.) are newly developed point-of-care (POC) assays for measuring sST2 level. We evaluated the performance of these assays, in terms of cut-off validation and prognosis, and compared them with that of the Presage ST2 assay (Presage ST2, Critical Diagnostics, San Diego, CA, USA). Methods: We validated the US FDA-claimed sST2 clinical cut-off of 35 ng/mL using 420 serum samples (298 samples from the universal sample bank of the American Association for Clinical Chemistry and 122 samples from reference individuals from Konkuk University Medical Center). We compared AFIAS ST2 and ichroma ST2 with Presage ST2, using 206 samples from patients with HF. We assessed prognosis using the three assays in 252 samples from the Barcelona ambulatory HF cohort subsets. Results: The upper reference limits of AFIAS ST2 and ichroma ST2 were within the clinical cut-off of Presage ST2. The results of AFIAS ST2 and ichroma ST2 were highly correlated with those of Presage ST2 (r = 0.82 and 0.81, respectively). Based on this cut-off, all three assays predicted cardiovascular death. Conclusions: The new POC assays, AFIAS ST2 and ichroma ST2, would be useful in clinical practice for managing HF patients, with performances equivalent to that of Presage ST2.
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Kim et al. (2023) conducted an observational in Heart Failure (n=878). AFIAS ST2 and ichroma ST2 assays vs. Presage ST2 assay was evaluated on Correlation of sST2 levels between assays (r = 0.82 and 0.81, p=<0.001). The AFIAS ST2 and ichroma ST2 point-of-care assays demonstrated high correlation (r = 0.82 and 0.81, respectively) with the Presage ST2 assay and equivalent performance in predicting cardiovascular death.
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