J Clin Pathol Qual Control.
1998 Dec;20(2):315-323.
Development and Evaluation of New Immunoturbidimetric Reagents for Apo A-I and B in the Human Serum
- Affiliations
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- 1Department of Clinical Pathology, Seoul National University College of Medicine and Seoul National University Hospital, Seoul 110-744, Korea.
- 2Samil Research Institute, Samil Pharmaceutical Co., Ltd, Ansan 425-090, Korea.
Abstract
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BACKGROUND: The measurement of these apolipoproteins are possible by various methods such as radioimmunoassay, radial immunodiffusion, electroimmunoassay, immunonephelometry and enzyme-linked immunosorbant assay. The immunoturbidimetric assay is rapid and easy to perform on automatic operation. We developed new immunoturbidimetric reagents for apo A-I and B determination.
METHODS
This reagents were composed with polyclonal antisera which were raised in goat with injection of purified apo A-I and B. Each antiserum revealed no cross reactivities with other lipoproteins of human serum. To evaluate the new reagents for clinical use, we compared with other commercial reagents.
RESULTS
In dilution test with purified HDL and LDL, we observed good linearity. In reproducibility assay, the within-run CVs were 4.3% and 3.6% and the between-run CVs were 9.0% and 5.8% for apo A-I and B respectively. Average analytical recovery was 102.8% for apo A-I and 101.4% for apo B, assaying human serum samples to which we added various amounts of purified HDL and LDL. We found a good correlations with other commercial reagents. The correlation coefficients with other immunoturbidimetric assay reagents were r=0.922 for apo A-I and r=0.924 for apo B and with other immunonephelometric assay reagents, r=0.931 for apo A-I and r=0.895 for apo B.
CONCLUSIONS
We concluded that these reagents are accurate, precise and suitable for use in clinical laboratories.