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Performance Evaluation of AFIAS ST2 and Ichroma ST2 Assays in Comparison with Presage ST2 Assay

Authors :
Hanah Kim
Tae-Hwan Lee
Mina Hur
Hyun-Joong Kim
Hyun Suk Yang
Kyeong Ryong Lee
Salvatore Di Somma
Source :
Reviews in Cardiovascular Medicine, Vol 24, Iss 4, p 100 (2023)
Publication Year :
2023
Publisher :
IMR Press, 2023.

Abstract

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.

Details

Language :
English
ISSN :
15306550
Volume :
24
Issue :
4
Database :
Directory of Open Access Journals
Journal :
Reviews in Cardiovascular Medicine
Publication Type :
Academic Journal
Accession number :
edsdoj.65895a003e09442aac37d02e1e0d46b5
Document Type :
article
Full Text :
https://doi.org/10.31083/j.rcm2404100