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

Autor:	Kim H; Department of Laboratory Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea., Lee TH; Department of Laboratory Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea., Hur M; Department of Laboratory Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea., Kim HJ; Division of Cardiology, Department of Internal Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea., Yang HS; Division of Cardiology, Department of Internal Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea., Lee KR; Department of Emergency Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea., Somma SD; Department of Medical-Surgery Sciences and Translational Medicine, School of Medicine and Psychology, Sapienza-University, Sant' Andrea Hospital, 00189 Rome, Italy.
Jazyk:	angličtina
Zdroj:	Reviews in cardiovascular medicine [Rev Cardiovasc Med] 2023 Mar 31; Vol. 24 (4), pp. 100. Date of Electronic Publication: 2023 Mar 31 (Print Publication: 2023).
DOI:	10.31083/j.rcm2404100
Abstrakt:	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. Competing Interests: The authors declare no conflict of interest. The Boditech Med’s support did not affect the results and conclusions of this study. (Copyright: © 2023 The Author(s). Published by IMR Press.)
Databáze:	MEDLINE
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