Kosin Medical Journal

Namhee Kim

2 Articles

Evaluation of automated calibration and quality control processes using the Aptio total laboratory automation system: Namhee Kim, Yein Kim, Jeongeun Park, Jungsoo Choi, Hyunyong Hwang; Kosin Med J. 2022;37(4):342-353. Published online December 22, 2022; DOI: https://doi.org/10.7180/kmj.22.144

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Abstract PDF PubReader ePub: Background
The objective of this study was to determine whether manually performed calibration and quality control (QC) processes could be replaced with an automated laboratory system when installed analyzers fail to provide automated calibration and QC functions.
Methods
Alanine aminotransferase (ALT), total cholesterol (TC), creatinine (Cr), direct bilirubin (DB), and lipase (Lip) items were used as analytes. We prepared pooled serum samples at 10 levels for each test item and divided them into two groups; five for the analytical measurement range (AMR) group and five for the medical decision point (MDP) group. Calibration and QC processes were performed for five consecutive days, and ALT, TC, Cr, DB, and Lip levels were measured in the two groups using automated and manual methods. Precision and the mean difference between the calibration and QC methods were evaluated using the reported values of the test items in each group.
Results
Repeatability and within-laboratory coefficients of variation (CVs) between the automated system and the conventional manual system in the AMR group were similar. However, the mean reported values for test items were significantly different between the two systems. In the MDP group, repeatability and within-laboratory CVs were better with the automation system. All calibration and QC processes were successfully implemented with the Aptio total laboratory automation system.
Conclusion
The Aptio total laboratory automation system could be applied to routine practice to improve precision and efficiency.

Agreement of three commercial anti-extractable nuclear antigen tests: EUROASSAY Anti-ENA Profile, Polycheck Autoimmune Test and FID^IS Connective Profile: Namhee Kim, In-Suk Kim, Chulhun L Chang, Hyung-Hoi Kim, Eun Yup Lee; Kosin Med J. 2018;33(3):307-317. Published online January 19, 2018; DOI: https://doi.org/10.7180/kmj.2018.33.3.307

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Abstract PDF PubReader: Background
Detection of antibodies to extractable nuclear antigens (ENAs) is needed for the diagnosis in systemic autoimmune diseases. In this study, we compared three reagents using line immunoblot assay (LIA) or multiplex bead immunoassay for detecting the anti-ENAs.
Methods
A total of 89 sera were tested by 3 different assays: EUROASSAY Anti-ENA Profile (Euroimmune, Germany), Polycheck Autoimmune Test (Biocheck GmbH, Germany), and FIDIS™ Connective Profile (Biomedical Diagnostics, France). The following individual ENAs were investigated: Sm, SS-A (Ro), SS-B (La), Scl-70, Jo-1 and RNP. We reviewed medical records to investigate the discrepant results among three methods.
Results
Overall percent agreements were 96.1% between EUROASSAY Anti-ENA Profile and FIDIS™ Connective profile; 90.4% between EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test using the manufacturers’ cutoff; 96.4% between EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test using a upward cutoff; 90.4% between FIDIS™ Connective profile and Polycheck Autoimmune Test the manufacturers’ cutoff; and 96.4% between FIDIS™ Connective profile and Polycheck Autoimmune Test a upward cutoff.
Conclusions
The three assays showed excellent agreement with each other. With appropriate cutoff, the all three assays for six of the anti-ENA tests investigated in this study can be used in clinical laboratories for detecting the anti-ENAs.

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