Performance comparison of EasyFix G26 and HYDRASYS 2 SCAN for the detection of serum monoclonal proteins

J Clin Lab Anal. 2020 Jun;34(6):e23254. doi: 10.1002/jcla.23254. Epub 2020 Mar 6.

Abstract

Background: Serum protein electrophoresis (SPE) is a widely used laboratory technique to diagnose patients with multiple myeloma (MM) and other disorders related to serum protein. In patients with MM, abnormal monoclonal protein can be detected by SPE and further characterized using immunofixation electrophoresis (IFE). There are several semi-automated agarose gel-based systems available commercially for SPE and IFE. In this study, we sought to evaluate the analytical performance of fully automated EasyFix G26 (EFG26) and semi-automated HYDRASYS 2 SCAN (H2SCAN) for both SPE and IFE.

Methods: Both instruments were operated according to manufacturer's instructions. Samples used include a commercially available normal control serum (NCS) and patients' specimens. The following were evaluated: precision and comparison studies for SPE, and reproducibility and comparison studies for IFE. Statistical analyses were performed using Microsoft Excel.

Results: For SPE repeatability study, our results showed that EFG26 has higher coefficient of variation (%CV) compared with H2SCAN for both samples except for monoclonal component with %CV of 0.97% and 1.18%, respectively. Similar results were obtained for SPE reproducibility study except for alpha-1 (4.16%) and beta (3.13%) fractions for NCS, and beta fractions (5.36%) for monoclonal sample. Subsequently, reproducibility for IFE was 100% for both instruments. Values for correlation coefficients between both instruments ranged from 0.91 to 0.98 for the five classic bands.

Conclusion: Both instruments demonstrated good analytical performance characterized by high precision, reproducibility and correlation.

Keywords: EasyFix G26; HYDRASYS 2 SCAN; immunofixation electrophoresis; serum monoclonal protein; serum protein electrophoresis.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Automation, Laboratory
  • Blood Protein Electrophoresis / instrumentation*
  • Blood Protein Electrophoresis / methods
  • Blood Proteins / analysis*
  • Blood Proteins / immunology
  • Humans
  • Immunoelectrophoresis / instrumentation*
  • Immunoelectrophoresis / methods
  • Myeloma Proteins / analysis
  • Reproducibility of Results

Substances

  • Blood Proteins
  • Myeloma Proteins
  • multiple myeloma M-proteins