IMR Press / RCM / Volume 24 / Issue 4 / DOI: 10.31083/j.rcm2404100
Open Access Original Research
Performance Evaluation of AFIAS ST2 and Ichroma ST2 Assays in Comparison with Presage ST2 Assay
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1 Department of Laboratory Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea
2 Division of Cardiology, Department of Internal Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea
3 Department of Emergency Medicine, Konkuk University School of Medicine, 05030 Seoul, Republic of Korea
4 Department of Medical-Surgery Sciences and Translational Medicine, School of Medicine and Psychology, Sapienza–University, Sant' Andrea Hospital, 00189 Rome, Italy
*Correspondence: dearmina@hanmail.net (Mina Hur)
Rev. Cardiovasc. Med. 2023, 24(4), 100; https://doi.org/10.31083/j.rcm2404100
Submitted: 20 July 2022 | Revised: 19 January 2023 | Accepted: 2 February 2023 | Published: 31 March 2023
Copyright: © 2023 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license.
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.

Keywords
soluble suppression of tumorigenicity 2
point-of-care
performance
cut-off
comparison
prognosis
heart failure
Funding
BDTSR2008-0088/Boditech Med
Figures
Fig. 1.
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