• The Korean Journal of Nuclear Medicine
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• v.21 no.2
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• pp.143-150
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• 1987

To assess the analytic performance of immunoradiometric TSH assay (IRMA TSH), assay precision determined by intra and interassay variance, assay accuracy determined by dilution and recovery study, were evaluated by using two commercial kit $(Abott^{(R)}\;and\;Daichi^{(R)})$. Normal range of basal serum TSH and TRH stimulated TSH increment were also determined in 234 healthy subjects (male 110, female 124; age 20-70) and 30 voluteers (male 10, female 20; age 21-26). In addition, basal TSH levels of 70 patients with untreated hyperthyroidism, 50 untreated hypothyroidism, and 60 euthyroidism were measured to assess the clinical utility of IRMA TSH. The detection limit of IRMA TSH was 0.04 mU/l and 0.08 mU/l by Abott Kit and Daichi kit respectively. Using Abott kit, intra assay variance were 2.0, 3.1 and 1.4% in mean TSH concentration 2.4, 31.6 and 98.2 mU/l repectively and interassay variance were 2.0 and 3.2% in mean TSH concentration 2.3 and 31.3 mU/l. Mean recovery rate was 92.5% and dilution study showed nearly straight line. When Daichi kit was used, intrasssay variance were 5.6, 5.2 and 6.2% in mean TSH concentration of 2.4, 31.6 and 98.2 mU/l respectively and interassay variance were 7.1 and 7.4% in mean TSH of 2.3 and 31.3 mU/l. Mean recoveray rate was 89.9%. Normal range of basal TSH and TRH stimulated peak TSH were 0.38-4.02 mU/l and 2.85-30.8 mU/l repectively (95% confidence interval, Abott kit used). Sensitivity and specificity of basal TSH levels for diagnosing hypothyroidism as well as specificity for diagnosing hyperthyroidism were 100% by using both kit. Sensitivity of basal TSH level for diagnosing hyperthyroidism was 100% when TSH levels were measured by Abott kit while that was 80.9% when measured by Daichi kit. These results suggest that IRMA TSH was very precise and accurate method and might be used as a first line test in the evaluation of thyroid function.

• Journal of Nutrition and Health
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• v.29 no.9
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• pp.971-980
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• 1996

The soluble transferrin receptor(TfR) in human serum has been shown recently to be a truncated form of intact membrane bound receptor containing most of the extracellular domain. We purfied the transferin-free TfR from human serum by immounoaffinity chromatography which produced the single protein identity in high resolution gel chormatography. The monoclonal antibodies(MAb) against purifed serum TfR were produced by fusion of spleen cells o fimmunized Balb/c mice and SP2 cells. Ten hybrids producing MAb specific for serum TfR were identifed and determine their iostypes. A immunoraddiometric assay (IRMA) for serum TfR was established using two monoclonal IgG1 antibodies as the coating and indicator antibodies on the bosis of their suitability in sandwich IRMA of serum TfR. The mean serum TfR levels in the 15 normal male, 15 normal female, and 19 iron-deficient subjects were 5.4$\pm$0.98, 4.6$\pm$0/76, and 18.0$\pm$12.8mg/1, respectively, and the difference in mean values between normal and iron deficient subjects was significant(p=0.0005). There existed the inverse logarithmic relationship(r=-0.9336, p<0.0001) between the serum TfR and ferritin levels.

• The Korean Journal of Nuclear Medicine
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• v.34 no.4
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• pp.353-359
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• 2000

Purpose: Although ${\alpha}$-fetoprotein is one of the most commonly used tumor markers in Korea, most of the radioimmunoassay kits for ${\alpha}$-fetoprotein have been imported from foreign countries. The purpose of this study was to evaluate the performance of a recently developed domestic immunoradiometric kit for ${\alpha}$-fetoprotein (Riakey AFP IRMA $CT^R$, Sin-Jin Medics, Seoul, Korea). Materials and Methods: We evaluated intra- and inter-assay precision, recovery rate, parallelism, and sensitivity of serum ${\alpha}$-fetoprotein measurement using Riakey AFP IRMA $CT^R$ kit. The values of ${\alpha}$-fetoprotein measured by Riakey AFP IRMA $CT^R$ kit were compared with those measured by two foreign commercial kits (${\alpha}$-fetoproteina of Radim and ${\alpha}$-feto.riabead of Abbott). Results: Intra-assay coefficients of variation on three different levels were 5.3% for 18.9 ng/ml, 3.4% for 133 ng/ml and 1.6% for 330 ng/ml. Inter-assay coefficients of variation were 9.7% for 20.9 ng/ml, 3.2% for 137 ng/ml and 4.1% for 330 ng/ml respectively. Recovery rate tests on all three different levels showed within $100{\pm}10%$. Parallelism was also good and the sensitivity was 0.63 ng/ml. There was strong correlation between the measurement of ${\alpha}$-fetoprotein by Riakey AFP IRMA $CT^R$ and that by two foreign commercial kits(r=0.98). Conclusion: The first Korean domestic immunoradiometric kit for ${\alpha}$-fetoprotein, Riakey AFP IRMA $CT^R$, performed well for clinical use.

• The Korean Journal of Nuclear Medicine Technology
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• v.27 no.1
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• pp.29-35
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• 2023

Purpose The concentration of PSA (Prostate Specific Antigen) after radical prostatectomy in prostate cancer patients is a predictor of biochemical recurrence, and the AUA (American Urological Association) is defined as biochemical recurrence when the concentration of PSA is measured at 0.2 ng/mL or more, and when the concentration is measured at 0.2 ng/mL or more at the retest. This standard is also applied our hospital. In this laboratory, the PSA reagent using IRMA (Immunoradiometric Assay) is used, and the sensitivity at a very low value was not as good as the reagent used in the department of laboratory medicine. This study aims to increase the reliability of the results by improving the precision and sensitivity of very low values. Materials and Methods As a reagent for the study, PSA reagent using IRMA was used. As a method to improve the precision and sensitivity of very low values, a variation method on the serum volume(25 uL, 50 uL, 100 uL, 200 uL) was studied, and variation usefulness evaluation was conducted. The evaluation items were compared the results of precision, analytical sensitivity, recovery rate, dilution test, high-dose hook effect test, parallel test and very low concentration values(n = 20). Results The validation results were displayed in the order of 25 uL, 50 uL, 100 uL, 200 uL. As the serum volume increased, it was confirmed that CV (Coefficient of Variation)(%) improved. Analytical sensitivity(ng/mL) was 0.038, 0.041, 0.017, 0.015 and recovery rate(%) was 101±3, 101±3, 99±2, 97±4. very low concentration values(ng/mL) between each volume(n=20) were 0.135±0.068, 0.076±0.050, 0.048±0.034, 0.046±0.034. and high dose hook effect appeared as the serum volume increased. Conclusion Through the variation usefulness evaluation, it was confirmed that as the serum volume increased, the precision and sensitivity improved at very low concentration values. However, it is necessary to pay special attention to the occurrence of high-dose hook effect as the serum volume increases. In the case of tests that requires very low concentration values, it is thought that the reliability of the result will be increased if the variation method is properly used after the variation usefulness evaluation.

• The Korean Journal of Nuclear Medicine Technology
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• v.23 no.1
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• pp.35-39
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• 2019

Purpose Hepatitis B virus (hepatitis B virus, HBV) infection is a worldwide major public health problem and it is known as a major cause of chronic hepatitis, liver cirrhosis and liver cancer. And serologic tests of hepatitis B virus is essential for diagnosing and treating these diseases. In addition, with the development of molecular diagnostics, the detection of HBV DNA in serum diagnoses HBV infection and is recognized as an important indicator for the antiviral agent treatment response assessment. We performed HBeAg assay using Immunoradiometric assay (IRMA) and Chemiluminescent Microparticle Immunoassay (CMIA) in hepatitis B patients treated with antiviral agents. The detection rate of HBV DNA in serum was measured and compared by RT-PCR (Real Time - Polymerase Chain Reaction) method Materials and Methods HBeAg serum examination and HBV DNA quantification test were conducted on 270 hepatitis B patients undergoing anti-virus treatment after diagnosis of hepatitis B virus infection. Two serologic tests (IRMA, CMIA) with different detection principles were applied for the HBeAg serum test. Serum HBV DNA was quantitatively measured by real-time polymerase chain reaction (RT-PCR) using the Abbott m2000 System. Results The detection rate of HBeAg was 24.1% (65/270) for IRMA and 82.2% (222/270) for CMIA. Detection rate of serum HBV DNA by real-time RT-PCR is 29.3% (79/270). The measured amount of serum HBV DNA concentration is $4.8{\times}10^7{\pm}1.9{\times}10^8IU/mL$($mean{\pm}SD$). The minimum value is 16IU/mL, the maximum value is $1.0{\times}10^9IU/mL$, and the reference value for quantitative detection limit is 15IU/mL. The detection rates and concentrations of HBV DNA by group according to the results of HBeAg serological (IRMA, CMIA)tests were as follows. 1) Group I (IRMA negative, CMIA positive, N = 169), HBV DNA detection rate of 17.7% (30/169), $6.8{\times}10^5{\pm}1.9{\times}10^6IU/mL$ 2) Group II (IRMA positive, CMIA positive, N = 53), HBV DNA detection rate 62.3% (33/53), $1.1{\times}10^8{\pm}2.8{\times}10^8IU/mL$ 3) Group III (IRMA negative, CMIA negative, N = 36), HBV DNA detection rate 36.1% (13/36), $3.0{\times}10^5{\pm}1.1{\times}10^6IU/mL$ 4) Group IV(IRMA positive, CMIA negative, N = 12), HBV DNA detection rate 25% (3/12), $1.3{\times}10^3{\pm}1.1{\times}10^3IU/mL$ Conclusion HBeAg detection rate according to the serological test showed a large difference. This difference is considered for a number of reasons such as characteristics of the Ab used for assay kit and epitope, HBV of genotype. Detection rate and the concentration of the group-specific HBV DNA classified serologic results confirmed the high detection rate and the concentration in Group II (IRMA-positive, CMIA positive, N = 53).

• The Korean Journal of Nuclear Medicine
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• v.38 no.6
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• pp.532-539
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• 2004

Purpose: There has been a renewal of interest in Macrophage migration inhibitory factor (MIF), especially correlation in pathogenesis of sepsis by many infectious diseases and in regulation of host inflammatory and immune response. We developed immunoradiometric assay (IRMA) to determine serum human MIF concentration. Materials and Methods: The IRMA system utilizes solid phase bound monoclonal anti-recombinant human MIF (rhMIF) antibody as a capture antibody, biotinylated polyclonal anti-rhMIF antibody as a detector antibody. We applied with rhMIF that concentration of standard solutions increased from 0 ng/ml to 100 ng/ml. We used $^{125}I$-streptavidin (SA) as radiotracer to determination of rhMIF concentration. Streptavidin was labeled with $^{125}I$ by Chloramine-T method and $^{125}I$-SA was purified by ultracentrifugation. $^{125}I$-SA stability was evaluated by ITLC analysis at $4^{\circ}C$ and room temperatures until 60days. To validate IRMA system for MIF, we experimented intra-assay and inter-assay coefficients of variation, recovery test and dilution test. Results: Radiolabeling yield of $^{125}I$-SA was 87% and purified $^{125}I$-SA retained above 99% radiochemical purity. $^{125}I$-SA showed above 93% stability in $4^{\circ}C$ until 60days that it is good for immunoradiometric assay as radiotracer. Plotted standard dose response curve showed that increased concentration of rhMIF linearly correlated (R2=0.99) with bound radioactivity of $^{125}I$-SA. The highest intra- and inter-assay coefficients of variation were 5.5% and 7.6%, respectively. The average of recovery of MIF in samples was 102%. In dilution test, linear response curves were obtained (R2=0.97). Conclusion: Radioimmunoassay using $^{125}I$-SA as radiotracer thought to be useful for the determination of serum MIF concentration, and further, its data will be used to evaluate the correlation between clinical significance and serum MIF concentration in patients with various inflammatory diseases.

• The Korean Journal of Nuclear Medicine Technology
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• v.23 no.2
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• pp.43-50
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• 2019

Purpose The principle of nuclear medicine test is divided into two main categories: competition(radioimmunoassay, RIA) and noncompetitive reaction(Immunoradiometric assay, IRMA). It is known that the curve fitting method, which is commonly used in inspection field, uses Spline interpolation in RIA method and Linear interpolation method in IRMA method. Among them, the insulin test using the IRMA test showed a significant difference, especially at low concentrations, despite the same algorithm of linear interpolation between fully automated radio immunoassay analyzers. In this study, we aim to obtain results from applying two different of algorithm using fully automated radio immunoassay analyzers including Gamma pro, Gamma 10, Cobra, and SR300. Materials and Methods A total of 30 test samples were selected for the test of TSH, ferritin, C-peptide, and insulin serum levels. Test was performed by IRMA method. We compared the difference in the results of applying the linear interpolation method and the spline interpolation method to Gamma Pro, Gamma 10, Cobra, and SR300 equipment. Results Two-way ANOVA was used for statistical analysis. The significance level was applied as P <0.05. The results of TSH, ferritin, C-peptide, and insulin tests were compared between the fully automated radio immunoassay analyzers. There was a significant difference between ferritin, C-peptide, and insulin serum levels(P<0.001). TSH didn't show any significant different between the devices(P=0.29). In the difference between linear and spline interpolation, there was no significant difference between insulin test(P=0.08), TSH test(P=0.81), and Ferritin test(P=0.06). However, C-peptide test showed a significant difference(P=0.03). Especially, the insulin test showed significant difference in lower ranges. As a result of comparing and analyzing the difference between the two interpolation methods, the devices in the low concentration group showed significant difference(P<0.001). Conclusion In case of new equipment in the laboratory it is necessary to recognize that there is a difference in the curve fitting method for each automated radio immunoassay analyzers in the low concentration area when the principle of inspection is IRMA method.

• Journal of The Korean Society of Integrative Medicine
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• v.6 no.1
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• pp.63-74
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• 2018

Purpose: The purpose of this study was to evaluate the effect of a trunk stabilization exercise program on the participants' scoliosis angle, pulmonary function, and growth hormones. Method: In the study, 30 participants were divided into a normal scoliosis exercise group (n=15) and an obese scoliosis exercise group (n=15). The participants performed a trunk stabilization exercise program three times a week for 12 weeks, and the exercise sessions lasted 50 minutes. The participants' pulmonary function [FVC, FEV1, FEV1/FVC, and PEF] was measured using a CardioTouch 3000S, and their scoliosis angles were measured using the Cobb's angle. The levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) were analyzed on an immunoradiometric assay (IRMA) and radioimmunoassay (RIA), respectively. Results: After the intervention, the scoliosis angle, hormone levels, and pulmonary function increased significantly in both groups (p<.05). The result of the intergroup difference test indicated statistically significant differences in the three items (scoliosis angle, hormone levels, and pulmonary function) between the two groups (p<.05). Conclusion: Therefore, this program may be recommended as a therapeutic intervention for patients with scoliosis.

• The Korean Journal of Nuclear Medicine Technology
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• v.13 no.1
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• pp.116-119
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• 2009

Background: Preanalytical factors can affect reliability of hormone assay results. Adrenocorticotropic hormone (ACTH) in blood is considered highly unstable because of proteolytic degradation, so storage of blood samples on ice until analysis is recommended. In clinical practice, however, this procedure may present logistical problems because most samples for ACTH measurement must be shipped from the place of sample collection to the laboratory. Therefore, we studied the impact of time and temperature before plasma separation and analysis on the results of ACTH assays. Methods: A total number of 22 patients were enrolled in this study. We obtained 2 blood samples. ACTH concentrations were 35~126 pg/mL. ACTH concentrations were measured by immunoradiometric assay (IRMA) using commercial kits (CIS Biointernational, Gif-sur-Yvette, France). Results: ACTH levels showed a significant difference between the samples of $22^{\circ}C$ EDTA and $4^{\circ}C$ EDTA. Measured ACTH concentrations significantly decreased with time before freezing at $-20^{\circ}C$. ACTH levels showed no significant difference between the groups of after storage for 24 hr without centrifugation at $22^{\circ}C$ and $4^{\circ}C$. Conclusion: We recommend that blood samples be obtained on pre-chilled EDTA collection tubes. The shortest possible time between sample collection and processing is always the best laboratory practice.

• Clinical and Experimental Pediatrics
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• v.51 no.12
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• pp.1329-1335
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• 2008

Purpose : This study aimed to determine the best cutoff line for insulin-like growth factor (IGF)-I and insulin-like growth factor binding protein (IGFBP)-3 to discriminate between growth hormone deficiency (GHD) patients and the control group. Methods : Two hundred thirty subjects with normal controls (129 boys and 101 girls, aged 7-15 years), 14 patients with complete GHD (12 boys and 2 girls), and 17 patients with partial GHD (9 boys and 8 girls) were studied. IGF-I serum concentrations were measured by radioimmunoassay (RI), and IGFBP-3 concentrations were measured by immunoradiometric assay (IRMA). Results : The receiver operating characteristic (ROC) plot analysis showed that the best IGF-I and IGFBP-3 cutoff line was at -1 standard deviation (SD). By comparing IGF-I serum levels of GHD children within 1 SD of normal control, we determined the sensitivity (S) (87.5-100%) and specificity (Sp) (80-84.6%) according to the age group. For IGFBP-3, we determined the following values: S (58.7-85.7%) and Sp (79.2-85.5%). Eleven of 14 patients with complete GHD (78.5%) and 16 of 17 patients with partial GHD (94.1%) had IGF-I concentrations equal to or below -1 SD of the control group mean. Ten of 12 complete GHD children (83.3%) and 13 of 17 partial GHD children (76.5%) had IGFBP-3 concentrations equal or below -1 SD of the control group mean. Conclusion : We conclude that the measurement of IGF-I and IGFBP-3 concentrations might provide essential supplementary data in the diagnostic evaluation of patients with GHD. Our results support the need to use cutoff lines based on below -1 SD of the control.