KMID : 1143620180220020101
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Korean Journal of Nuclear Medicine Technology 2018 Volume.22 No. 2 p.101 ~ p.104
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Evaluation of the Kit's Efficiency of Alpha Fetoprotein (AFP) Test
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Cho Hyun-Su
Noh Kyeong-Woon Yoo Tae-Min
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Abstract
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Purpose : Alpha fetoprotein(AFP) is a fetal serum protein that increases in germ cell tumors derived from liver cancer or egg yolk. AFP test has been used for screening of liver cancer, determination of tumor stage, determination of therapeutic effect, and fetal congenital malformations. The purpose of this study was to compare the results of the four kits, identify the advantages and disadvantages of each kit, and select the appropriate kits for our laboratory.
Materials and Methods : Blood samples were obtained from 89 patients attending the Seoul national university hospital. Experiments were carried out in accordance with manufacturer's instructions of four companies(A, B, C, D). The precision, recovery, linearity, and sensitivity test were performed for each kit.
Results : In case of the precision within the measurement, the CV value of the C kit was less than 5% at the low, middle, and high concentrations. The A, B and D kit's the CV value was less than 5% at the concentrations except the low concentration. The recovery rates of the A, B, C, and D kits were 100 ¡¾ 15%, 100 ¡¾ 30%, 100 ¡¾ 16% and 100 ¡¾ 14%, respectively. All kits showed good linearity. Sensitivity was measured as 0.5 IU/mL for A, 0.4 IU/mL for B, 0.98 IU/mL for C, and 0.3 IU/mL for D.
Conclusion : The CV values of the four kits were within 10%, and the correlation coefficients were close to 1 for R©÷ = 0.978,
R©÷ = 0.992 and R©÷ = 0.8957. As a result, they are clinically available. Therefore, each laboratory should select the appropriate kit for their experiment's environment.
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KEYWORD
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Alpha feto protein(AFP) , the evaluation of kit validation
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