Related Experiment Video
Updated: Nov 2, 2025
Using Extraordinary Optical Transmission to Quantify Cardiac Biomarkers in Human Serum
Published on: December 13, 2017
Analytical characterization and clinical performance evaluation of a new point-of-care testing system for
Rui Zhang1, Yueyu Hong1,2, Jie Shi1
1Department of Clinical Laboratory, Beijing Chao-yang Hospital, Capital Medical University, Beijing, People's Republic of China.
Background:
We aimed to evaluate the analytical performance and clinical diagnostic accuracy of the SuperFlex point-of-care testing (POCT) high-sensitivity cardiac troponin I (hs-cTnI) assay system.
Method:
The imprecision, the limit of blank, the limit of detection, the limit of quantitation, linearity and comparability were assessed as per the Clinical and Laboratory Standards Institute guidelines. Also, the 99th-percentile reference value and diagnostic accuracy were evaluated.
Results:
The reproducibility and total imprecision were 1.52-1.92% and 2.69-2.92%, respectively. Limit of blank and limit of detection were 1 ng/L and 1.8 ng/L, respectively, and limit of quantitation was 12 ng/L at 10% coefficient of variation (CV). The results met the requirements of linearity, and the correlation coefficient was 0.996. The SuperFlex POCT results had good agreement with those obtained by the Siemens Advia 2400. The CV% was 7.24% at the 99th percentile concentration (p99th) of 25.6 ng/L (95% confidence interval: 22.0-33.3 ng/L) from 620 healthy subjects. The sex-partitioned CV% and p99th were 7.15% at 27 ng/L (males; n = 308) and 7.35% at 24 ng/L (females; n = 312), respectively (P < 0.0001). The hs-cTnI detection rate of all observed healthy individuals from limit of detection to 99th was 82.57% by the SuperFlex POCT assay, 89.90% for the males and 75.48% for the females. The sensitivity, specificity, positive predictive value and negative predictive value of diagnostic performance for acute myocardial infarction were 100%, 81.25%, 57% and 100%, respectively.
Conclusions:
The SuperFlex POCT system showed the analytical performance characteristics required for enabling the clinical use of a hs-cTnI assay.
More Related Videos
10:12A Sensitive and Specific Quantitation Method for Determination of Serum Cardiac Myosin Binding Protein-C by Electrochemiluminescence Immunoassay
Published on: August 8, 2013
05:58Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
Published on: March 22, 2022
Related Concept Videos
01:20Blood Studies for Cardiovascular System I: Cardiac Biomarkers
The essential diagnostic tools for detecting myocardial necrosis and monitoring individuals suspected of having acute coronary syndrome (ACS) include:
Troponins
Troponins, particularly cardiac troponins I and T, are the most precise and sensitive markers of myocardial injury. They are detectable within 4-6 hours of myocardial injury and remain...
01:30Acute Coronary Syndrome III: Diagnostic Studies
01:19Blood Studies for Cardiovascular System II: CRP, Hcy, and Cardiac Natriuretic Peptide Markers
These markers indicate stress or strain on the heart muscle:
Natriuretic Peptides (BNP)
Cardiac myocytes produce these hormones in response to ventricular stretching...