Performance of ivisen IA-1400, a new point-of-care device with an internal centrifuge system, for the measurement of cardiac troponin I levels

Ha Nui Kim, Soo Young Yoon

Research output: Contribution to journalArticlepeer-review

Abstract

Background: We present the analytical performance of the ivisen IA-1400, a new point-of-care device that features a characteristic built-in centrifuge system, to measure blood cardiac troponin I (cTnI) levels. Methods: Whole blood and plasma samples obtained from patients who visited Korea University Guro Hospital were used to analyze measurement range, cross-reactivity, interference, and sensitivity and specificity. We performed a correlation analysis of the ivisen IA-1400 versus the Access AccuTnI+3 immunoassay using the UniCel™ DxI 800 platform and the PATHFAST™ hs-cTnI assay. Results: Within-run precisions were classified as low, 9.8%; middle, 10.2%; and high, 8.5%. The limit of blank was 3.1 ng/L for plasma samples and 4.3 ng/L for whole blood samples. The limit of detection was 8.4 ng/L for plasma samples and 10.0 ng/L for whole blood samples, respectively. The limit of quantitation at a coefficient of variation of 20% and 10% was 19.5 ng/L and 45.5 ng/L for plasma samples, respectively. The comparative evaluation between the two other assays and ivisen IA-1400 showed excellent correlation, with Spearman's correlation coefficients (R) of 0.992 and 0.985. The sensitivity and specificity of ivisen IA-1400 using the optimum cut-off value of 235 ug/L were 94.6% and 98.2%, respectively. Conclusion: The ivisen IA-1400 showed acceptable and promising performance in cTnI measurements using whole blood and plasma samples, with limited information in the clinical performance. The flexibility for sample selection using the internal centrifugation system is the main advantage of this point-of-care device.

Original languageEnglish
Article numbere23747
JournalJournal of Clinical Laboratory Analysis
Volume35
Issue number5
DOIs
Publication statusPublished - 2021 May

Keywords

  • cardiac troponin
  • cardiac troponin I
  • i-SENS
  • ivisen IA-1400
  • point-of-care

ASJC Scopus subject areas

  • Immunology and Allergy
  • Hematology
  • Public Health, Environmental and Occupational Health
  • Clinical Biochemistry
  • Medical Laboratory Technology
  • Biochemistry, medical
  • Microbiology (medical)

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