A New Hematocrit Measurement Method Using a Chemiluminescence Biosensor and Its Application in a Chemiluminescence Immunoassay Platform for Myocardial Markers Detection with Whole Blood Samples

Abstract

The accuracy and precision of analyte concentrations measured in whole blood by chemiluminescence immunoassay (CLIA) have been significantly affected by erythrocytes, which leads to poor application of whole blood CLIA in clinical practice. In this work, a chemiluminescence biosensing optical platform for blood hematocrit (HCT) analysis using MAGICL 6000 (Getein Biotechnology, Nanjing, China) was designed, implemented, and fully characterized. The developed method was successfully applied to determine various HCT levels of human blood from 0% to 65%, with a correlation coefficient of 0.9885 compared with the conventional method (Sysmex XE 5000, Kobe, Japan). A mathematical model was developed to quantitatively evaluate the impact of HCT on the results of two sample types (whole blood vs. plasma). Combining the established HCT method and mathematical model with CLIA on MAGICL 6000, the precision was significantly improved by almost 20%. Comparison studies using whole blood samples and corresponding plasma samples showed that the square of the correlation coefficients of troponin I (cTnI), myoglobin (MYO), creatine kinase MB (CK-MB), and N-terminal pro-hormone brain natriuretic peptide (NT-proBNP) were increased to 0.9992, 0.9997, 0.9996, and 0.9994, respectively, showing a great potential for clinical application.

The cavity perturbation method for evaluating hematocrit via dielectric properties

“…The method is a useful tool based on measuring the conductivity of human blood at low frequencies and at body temperature [18,19]. Recently, a chemiluminescence biosensor employing a CLIA-based system effectively quantified the human blood hematocrit percentage from 0% to 65% [20].…”

“…It appeared that the hematocrit had a significant impact on these parameters [28]. In a recent study, the effects of physiological solutions with varying NaCl concentrations, HCT levels, and different albumin extracted from bovine blood were studied to determine the dielectric properties at frequencies between 0.5 GHz and 20 GHz using an open-ended co-axial probe. The measurements showed linear relationships between permittivity and various levels of HCT, albumin, and osmolality [29].…”