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KMID : 0861420120160020149
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Korean Journal of Nuclear Medicine Technology
2012 Volume.16 No. 2 p.149 ~ p.155
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The Evaluation of Radioimmunoassay kits for Insulin
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Shin Yong-Hwan
Kim Yun-Hyun
Lee Il-Kyu
Kim Ji-Young
Seok Jae-Dong
Shin Sook-Hee
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Abstract
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Purpose:Serum insulin levels are useful indicator which of reflecting the function of insulin secretion in
pancreatic β cell and diagnosis of diabetes, differentiating the cause of impaired glucose tolerance. Insulin
measurement kits have shown some differences in many ways such as test methods as well as quality control.
The purpose of this study was to evaluate the diagnostic performance of seven manufacturing companies
commercial kits.
Materials and Methods: The values of insulin measured by three manufacturing companies
(Biosource, Siemens, TFB) with 59 samples in August 2009 were compared with those measured by four
manufacturing companies (Immunotech, Izotope, BNIBT, Cisbio) with 68 samples in December 2011. We
evaluated precision, recovery rate, dilution test and correlation of serum insulin measurement using seven
manufacturing company kits. Statistical program SPSS 12.0 was used for the verification of results.
Results:The coefficients variation of the precision on all seven different kits were showed within 5.0%. Recovery rate of Biosource, Siemens, TFB kits on three different levels showed 94.2~103.7%, 99.0~104.6%, 99.7~ 107.6%
respectively. Immunotech, Izotope, BNIBT, Cisbio were 93.5~99.1%, 91.4~99.1%, 99.2~131.0%, 84.8~102.3%
respectively. There was strong correlation between the measurement of insulin by Biosource kit and that by two
commercial kits, Siemens (R2=0.96), TFB (R2=0.99). There was good correlation between the measurement of
insulin by TFB kit and that by three commercial kits, Immunotech (R2=0.97), Izotope (R2=0.96), Cisbio
(R2=0.97). In the dilution test performed with more than 200 μIU/ml high concentration samples, samples with
diabetes correctly was measured in all seven manufacturing kits. However, as measured with insulinoma
samples TFB, Siemens, Izotope, Cisbio kits were correctly measured , but Biosource and Immunotech kits were
measured 47.4 μIU/ml, 72.3 μIU/ml, respectively.
Conclusion:Serum Insulin radioimmunoassay kits were
showed excellent precision, correlation and good recovery rate. However, some kits were not measured correctly
in the high concentration insulin values. when selecting a kit should be considered many factors that cost
effectiveness, compatible for automation equipment, high performance kit, the environment for each laboratory
such as reaction time and reporting time.
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KEYWORD
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Radioimmunoassay, Precision, Recovery, Correlation, Dilution test, Insulin
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