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KMID : 0384120010210010183
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Korean Journal of Clinical Pathology
2001 Volume.21 No. 1 p.183 ~ p.188
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The preliminary study of AFP radioimmunoassay by made in Korea
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Abstract
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For the practical use of AFP RIA kit developed by G company we performed its quality control. Samples were 391 cases containing outrange the standards. They were accepted from September 1988 to January 1989 at department of nuclear medicine, Seoul National University Hospital.
The experiment was performed in a day by the protocol developed by the company to obtain homogenous condition. The results show:
1. The CV´s of control groups low, medium and high control samples falled in 5.1-7.5% and in 6.0-9.5% in Intra and Inter assay performances respectively.
These results are similar to those obtained by the kits produced in A(2-7.5) and B(6.2-6.6) company.
2. Sensitivity was 1.5ng / ml.
3. Hook effect was not observed.
4. Recovery rate was in 92-106.5%. This result in similar to those obtained by the kits produced in A(94-100%) and D(87-113%) company.
5. Linearity and recovery rate(83-104%) were confirmed by serialy diluted sample.
6. The values of 326(83%) samples falled in 1-700ng / ml range and the other 65(17%) over 700ng / ml in all 391 samples. Correlation coefficients of the kits G vs A, G vs D and A vs D were 0.98, 0.97and 0.98 respectively.
From these results we could not find any significant difficulties from the 3 kits.
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