Elsevier

Clinical Biochemistry

Volume 79, May 2020, Pages 48-53
Clinical Biochemistry

Evaluation of the new Beckman Coulter Access hsTnI: 99th percentile upper reference limits according to age and sex in the Korean population

https://doi.org/10.1016/j.clinbiochem.2020.02.005Get rights and content
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open access

Highlights

  • The 99th percentile URLs of Access hsTnI in the Korean population were lower than the manufacturer’s.

  • cTnI values were significantly higher in men and in the older age group.

  • Beckman Coulter Access hsTnI assay met the performance criteria of the IFCC for hs-cTnI assays.

Abstract

Background

Defining the 99th percentile upper reference limits (URL) of cardiac troponin I (cTnI) is critical because it is clinically important in determining myocardial injury, and is variable among reagents, age, sex, or races. The analytical performance of the new, high- sensitivity reagent Beckman Coulter Access hsTnI was evaluated, and its 99th percentile URL was determined in the Korean population.

Methods

Analytical performances of Access hsTnI assay were evaluated including imprecision and limit of measurements. To define the reference limits, 600 healthy subjects were included with similar proportions of sex and age groups.

Results

Beckman Coulter Access hsTnI assay presented a limit of blank, detection, and quantitation at 10% CV of 0.32 ng/L, 0.63 ng/L, and 6.1 ng/L, respectively, and 98.3% of the healthy population showed cTnI above the limit of detection. The 99th percentile URLs were 9.5 ng/L (90% CI 7.4–14.9), 7.8 ng/L (90% CI 5.5–19.2 ng/L), and 11.3 ng/L (90% CI 8.0–15.7 ng/L) in 600 healthy participants, 300 women and 300 men, respectively with imprecision less than 10% CV. The median values and 99th percentile URLs of hsTnI were higher in men and the age group ≥50 years than in women and the age group <50 years, respectively.

Conclusions

Access hsTnI assay met the performance criteria of the IFCC for high-sensitivity cTnI assays. Their 99th percentile URLs in the Korean population were lower than the manufacturer’s claims. cTnI values were significantly different among different sex and age groups.

Abbreviations

AMI
acute myocardial infarction
cTn
cardiac troponin
hs-cTnI
high-sensitivity cardiac troponin I
URL
upper reference limit
IFCC
International Federation of Clinical Chemistry and Laboratory Medicine
CV
coefficient of variation
LOD
limit of detection
LOQ
limit of quantitation
hs
high sensitivity
LOB
limit of blank
CLSI
Clinical and Laboratory Standards Institute
AMR
analytical measurement range
eGFR
estimated glomerular filtration rate
CI
confidence interval
IQR
interquartile range

Keywords

Hs-cTnI
Beckman Coulter Access hsTnI assay
Upper reference limits
Acute myocardial infarction

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