• The Korean Journal of Nuclear Medicine Technology
• /
• v.23 no.1
• /
• pp.35-39
• /
• 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 Technology
• /
• v.14 no.2
• /
• pp.208-211
• /
• 2010

Purpose: $TFB^{(R)}$ CA19-9 IRMA kit uses beads coated with CA19-9 antibody. However, this mathod can not use automated equipment, and requires a long time test. Recently, CA19-9 IRMA kit developed by $TFB^{(R)}$ is coated with CA19-9 antibody to the polystyrene test tube and reaction at room temperature, and also reduced test time. This study evaluated the performance of a newly developed $TFB^{(R)}$ CA19-9 IRMA kit. Materials and Methods: This study were measured by using 56 patients sample of Boramae Medical Center and Seoul National University Hospital. We evaluated intra-and inter-assay precision, recovery rate, linearity, sensitivity and high dose hook effect of coated tube CA19-9 IRMA kit developed by $TFB^{(R)}$. The values of CA19-9 measured by $TFB^{(R)}$ bead kit were compared with those measured by $TFB^{(R)}$ coated tube kit. Results: ntra-assay coefficients of variation on three different levels were 4.1%, 4.0% and 4.2%. Inter-assay coefficients of variation were 7.6%, 4.3% and 7.8%. Recovery tests on all three different levels showed within $100{\pm}10%$. Linearity was good and sensitivity was 0.3 U/mL. High dose hook effect is not observed. There was strong correlation between bead kit and coated tube kit by $TFB^{(R)}$ CA19-9 IRMA kit. (y=0.9185x-0.953, $R^2$=0.9779) Conclusion: Coated tube CA19-9 IRMA kit developed by $TFB^{(R)}$ showed satisfactory precision, recovery rate, linearity, sensitivity and high dose hook effect.

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

• KIEAE Journal
• /
• v.5 no.2
• /
• pp.11-18
• /
• 2005

The Purpose of this study is development and analysis of Effluence Characteristic of the Rainfall in the IRMA Green Roof System(developed in KICT) Plus 50 program is an internal research project at KICT(Korean Institute of Construction Technology) which has it as an object ; to lengthen the building's life 50-year or more and reduce energy conception 50% than present. Green roof system is one of the most important theme in the Plus 50 program. Generally, a Green Roof System has a positive effect on the thermal conductivity in winter, the micro cooling effect on building and city by evaporation in summer, the flood-control effect by runoff-reduction or the treated rainwater-quality of green roof system and so on. However, inspection of the physical effect of green roof system does not consider in Korea. Above all, long-term monitoring and a whole observation of green roof system is needed to probate the effect. So a new experimental method could be tried in this research, which is never attempted in Korea. The measurement by a bucket with a great volume, 1L, gives a new dimension of measuring green roof effect to measure the permanent running flood from a wide roof. This offers a reasonable result on a long-term measuring of a running water. Additionally, the thermal behavior of the IRMA(Insulated Roof Membrane Assembly), known in the western europe as a reasonable solution at green roof system by economical benefits and easy construction, would be experimented.

• The Korean Journal of Nuclear Medicine Technology
• /
• v.15 no.1
• /
• pp.121-125
• /
• 2011

Purpose: The DNA-type virus HBV, discovered by D. Dane and others in 1976, is approximately 42nm big and known as the main cause of liver-related diseases around the world. HBsAg has 4 kinds of subtypes including adw, adr, ayw and ayr and besides common antigen factor a, there are d, y, r, w. From the methods of serologically testing HBV, IRMA, EIA and CLIa were developed for testing HBsAg and are being used in examining the surface antigen of HBV. In this study, among the methods for testing HBV, the recently developed RIAKEY Ultrasensitive HBsAg IRMA kit's sensitivity level and performance in detection of mutant forms were measured and compared with CLIA. Materials and methods: Two certified reference materials, which are WHO 1st International Standard 1985(80/549) and WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA), were used in the examination and the sensitivity level was measured by diluting these materials from 0.08 IU/ml to 0.005 IU/ml. The materials for examining the detection of mutant forms included 9 kinds of subtype 'ad' and one kind of subtype 'ay' purchased from DSI company. Also, with the use of positive and negative samples, they was compared with CLIA. Result: Ultrasensitive HBsAg kit based on IRMA method showed the detection of up to 0.01 IU/ml not only for WHO 1st International Standard 1985(80/549) but also for WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA) and the sensitivity level was measured as 0.01 IU/ml by WHO standard. In testing the performance for detection of mutant forms, the 9 kinds of subtype 'ad' and one kind of subtype 'ay' mutant materials were detected, demonstrating the capacity of detecting various types of mutant forms. Conclusions: With the clinical importance of sensitivity level and performance in detection of mutant forms increasing in the field of HBsAg diagnosis, the examination of IRMA's effectiveness using RIA method in the aspects of the sensitivity level and performance in detection of mutant forms was carried out and its result is as follows. The sensitivity level was measured as 0.01 IU/ml by WHO standard and it was possible to measure various types of mutant forms with high sensitivity. Thus it is suggested that more speedy and accurate reports could be produced from a nuclear medicine laboratory for clinical practitioners requiring results of various situations.

• The Korean Journal of Nuclear Medicine Technology
• /
• v.16 no.2
• /
• pp.156-161
• /
• 2012

Purpose : IRMA method for the experimental reagents, as set out in the manual settings for doing and reporting the test results should, in principle. But many of the reagents allows for the setting of the plot does not have a lot of information. Depending on the angle setting of the table make a difference in test results and what settings are best suited to investigate. Materials and Methods : The hospital has Boramae DREAM10, Cobra, SR-300's using the Immunotech TSH reagents have been compared with the measurements. Since then there using EXCEL calculation of the equipment compared with the measurement. Results : In the comparison between each piece of equipment 1.SR-300: DREAM 10 y = 1.1376x - 0.046 (LOG-LOGIT), 2.SR-300: COBRA y = 1.0985x + 0.042 (LOG-LOG) 3.DREAM10: COBRA y = 0.965x + 0.0887 (LOG-LOG) was the result. In all charts the same X, Y axis, X values were good in general when you have. Linear-Logit value of Cobra Dream10 and Excel tends to match the calculated values provided. Conclusion : Is to guide the B / max, B / Total Logit Y axis of the chart is set to draw a look at the value equation when the X-axis LOG a high concentration are disadvantages rising urgently toward the slope. Linear-Logit plots close to the straight line has a curve. If you have a chart to guide on setting AS setting and therefore, set to guide the absence of information on the need to set up the experiment are thought to pass through.

• The Korean Journal of Nuclear Medicine
• /
• v.34 no.4
• /
• pp.353-359
• /
• 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 Nurse
• /
• v.16 no.4 s.90
• /
• pp.41-47
• /
• 1977

• The Korean Journal of Nuclear Medicine
• /
• v.21 no.2
• /
• pp.143-150
• /
• 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
• /
• v.29 no.9
• /
• pp.971-980
• /
• 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.