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Determination of 97.5th and 99th percentile upper reference limits for heart-type fatty acid-binding protein (H-FABP) in a US population.

Authors :
Vera MA
Koch CD
Kavsak PA
El-Khoury JM
Source :
Clinica chimica acta; international journal of clinical chemistry [Clin Chim Acta] 2021 Dec; Vol. 523, pp. 397-401. Date of Electronic Publication: 2021 Oct 16.
Publication Year :
2021

Abstract

Background: Heart-type fatty acid binding protein (H-FABP), a low molecular weight protein found primarily in myocardial tissue, has been identified as a potential biomarker in the detection of acute coronary syndrome and acute kidney injury. To further investigate clinical utility, we sought to establish an upper reference limit (URL) of H-FABP within a healthy U.S.<br />Methods: Serum samples of healthy donors were acquired from the AACC Universal Sample Bank. We analyzed 355 samples for H-FABP concentration using the Randox Laboratories immunoturbidimetric assay on the Roche Cobas 8000 series analyzer.<br />Results: The final sample population consisted of individuals aged 18-74 y, with 170 males and 185 females. The distribution of the population exhibited a strong positive skew, affecting outlier analysis and URL determination. The 97.5th-percentile URL was found to be 7.4 ng/ml (95% CI: 6.3-9.2), while the 99th-percentile URL was 12.1 ng/ml (8.6-14.9).<br />Conclusion: As the URL for H-FABP is highly affected by population distribution and outlier removal, final determination for an assay cutoff should be made in the context of clinical utility, either as a standalone assay or in conjunction with other biomarkers, and the desired clinical sensitivity and specificity.<br /> (Copyright © 2021 Elsevier B.V. All rights reserved.)

Details

Language :
English
ISSN :
1873-3492
Volume :
523
Database :
MEDLINE
Journal :
Clinica chimica acta; international journal of clinical chemistry
Publication Type :
Academic Journal
Accession number :
34666029
Full Text :
https://doi.org/10.1016/j.cca.2021.10.011