Open AccessPerformance comparison of EasyFix G26 and HYDRASYS 2 SCAN for the detection of serum monoclonal proteins
Author(s) -
Amin Nordin Fatimah Diana,
Mohd Khalid Mohd Khairul Nizam,
Abdul Aziz Siti Mastura,
Mohamad Bakri Nor Aina,
Ahmad Ridzuan Siti Nurwani,
Abdul Jalil Julaina,
Habib Anasufiza,
Yakob Yusnita
Publication year - 2020
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.23254
Subject(s) - reproducibility , repeatability , chromatography , coefficient of variation , serum protein electrophoresis , immunofixation , monoclonal , chemistry , monoclonal antibody , medicine , immunology , antibody
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.