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KMID : 1143620220260020043
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Korean Journal of Nuclear Medicine Technology
2022 Volume.26 No. 2 p.43 ~ p.47
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A Study on the Establishment of Acceptable Range for Internal Quality Control of Radioimmunoassay
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Lee Young-Ji
Lee So-Young
Lee Sun-Ho
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Abstract
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Purpose: Radioimmunoassay implement quality control by systematizing the internal quality control system for quality assurance of test results. This study aims to contribute to the quality assurance of radioimmunoassay results and to implement systematic quality control by measuring the average CV of internal quality control and external quality control by plenty of institutions for reference when setting the laboratory's own acceptable range.
Materials and Methods: We measured the average CV of internal quality control and the bounce rate of more than 10.0% for a total of 42 items from October 2020 to December 2021. According to the CV result, we classified and compared the upper group (5.0% or less), the middle group (5.0~10.0%) and the lower group (10.0% or more). The bounce rate of 10.0% or more was compared by classifying the item of five or more institutions into tumor markers, thyroid hormones and other hormones. The average CV was measured by the overall average and standard deviation of the external quality control results for 28 items from the first quarter to the fourth quarter of 2021. In addition, the average CV was measured by the overall average and standard deviation of the proficiency results between institutions for 13 items in the first half and the second half of 2021. The average CV of internal quality control and external quality control was compared by item so we compared and analyzed the items that implement well to quality control and the items that require attention to quality control.
Results: As a result of measuring the precision average of internal quality control for 42 items of six institutions, the top
group (5.0% or less) are Ferritin, HGH, SHBG, and 25-OH-VitD, while the bottom group (≤10.0%) are cortisol, ATA, AMA, renin, and estradiol. When comparing more than 10.0% bounce rate of CV for tumor markers, CA-125 (6.7%), CA-19-9 (9.8%) implemented well, while SCC-Ag (24.3%), CA-15-3 (26.7%) were among the items that require attention to control. As a result of comparing the bounce rate of more than 10.0% of CV for thyroid hormones examination, free T4 (2.1%), T3 (9.3%) showed excellent performance and AMA (39.6%), ATA (51.6%) required attention to control. When comparing the bounce rate of 10.0% or more of CV for other hormones, IGF-1 (8.8%), FSH (9.1%), prolactin (9.2%) showed excellent performance, however estradiol (37.3%), testosterone (37.7%), cortis ol (44.4%) required attention to control. As a result of measuring the average CV of the whole institutions participating at external quality control for 28 items, HGH and SCC-Ag were included in the top group (≤10.0%), however ATA, estradiol, TSI, and thyroglobulin included in bottom group (≥30.0%).
Conclusion: As a result of evaluating 42 items of six institutions, the average CV was 3.7~12.2% showing a 3.3 times difference between the upper group and the lower group. Cortisol, ATA, AMA, Renin and estradiol tests with high CV will require continuous improvement activities to improve precision. In addition, we measured and compared the overall average CV of the internal quality control, the external quality control and the proficiency between institutions participating of six institutions for 41 items excluding HBs-Ab. As a result, ATA, AMA, Renin and estradiol belong to the same subgroup so we require attention to control and consider setting a higher acceptable range. It is recommended to set and control the acceptable range standard of internal quality control CV in consideration of many things in the laboratory due to the different reagents and instruments, and the results vary depending on the test's proficiency and quality control materials. It is thought that the accuracy and reliability of radioimmunoassay results can be improved if systematic quality control is implemented based on the set acceptable range.
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KEYWORD
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Internal Quality Control, External Quality Control, CV
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