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      • 동결건조표준액의 안정성에 관한 보고

        박준모,유혜정,김한철,한걸순,Park, Jun Mo,Yoo, Hye Jung,Kim, Han Chul,Han, Geul Soon 대한핵의학기술학회 2012 핵의학 기술 Vol.16 No.2

        이 실험은 검사를 매일 실행하고, 동결건조된 표준액을 매번 녹여서 사용하는 검사실은 그 안정성에 대하여 고민을 할 필요는 없지만, 검사를 일주일에 한번 또는 두 번 정도 실행하는 검사실에 대한 보고라고 할 수도 있다. 동결 건조한 표준물질은 용해한 후 다시 동결을 할 경우 보통 $-20^{\circ}C$이하에서 유효기간까지 보관하라는 식으로만 표현 되어져 있고, 이는 몇 번을 녹인 후 재사용해도 안정한가에 대해서는 표현된 바가 없기에 이번 실험은 동결건조한 표준용액을 녹임과 동결을 여러 번 번복하였을 때와 냉장보관을 하였을 시에 표준용액의 변화도와 이것이 결과에 미치는 영향을 비교 평가하였다. 시판되고 있는 방사면역측정법을 이용한 체외진단키트 중 동결건조표준용액으로 되어진 부갑상선호르몬(PTH), 부신피지자극호르몬(ACTH), 황체형성호르몬(LH) kit를 같은Lot.NO.로 구성하였다. 이를 D.W.로 각 용량에 맞게 용해한 후 3개의 대조군으로 분리하였다. 제1대조군은 녹임, 동결을 번복하는 방법으로 하였고 제2대조군은 용해한 후 Test tube에 1회 사용할 만큼 분주하여 동결을 하였고 제3대조군은 냉장보관으로 하였다. 표준액과 환자농도값 날짜 별로 비교하였고, pH Test를 하였으며 날짜 별 단순회귀분석 및 결정계수 산출을 하였으며 Excel Paired t-Test (p-value)를 하여서 유의수준관계를 분석하였다. 위에서 실험한 ACTH, PTH, LH의 동결건조 표준액은 반드시 냉동보관을 할 것을 권고한다. 이는 다른 동결건조표준액도 같은 방법으로 보관을 해야 할 것이다. Purpose : Since standard solution is the one that knows its exact concentration, the curve of the dissolution has been determined according to the amount of the solution, compared to the amount of the unknown sample. Therefore, the antigen that makes up standard materials should be made in a pure form. The configuration of the standard substance solution in the kit we use is a freeze-dried material, or made and comes as a liquid. Lyophilized reference material is used after dissolving in usually D.W. (Distilled Water), and if the antigen to use is too sensitive, reagents should be freeze-dried. Furthermore, when freeze-dried reference has to be frozen again after being dissolved, it should be kept under $-20^{\circ}C$ until the expiration date according to the reports. Since it is not expressed in the experiment if it is safe or stable to reuse the solution which was dissolved a few times, thus, this time it is tested and evaluated that the changes of the standard solution by freezing and melting several times, and its results and the effectiveness of it were compared to the solution which was kept in a fridge. Materials and Methods : Among Vitro diagnostic kits on the market made by radioimmunoassay, parathyroid hormone (PTH), adrenocorticotropic hormone (ACTH), luteinizing hormone (LH) are made of freeze-dried standard solution and all composed of the same Lot.NO. These hormones melted in D.W. and were separated into three groups. In the first group, melting and freezing were repeated, and in the second group, The solution only for one time use was put into a test tube after melting and freeze it. The third group was kept in the refrigerator. This experiment has been conducted from January to February in 2012. January to 2012. PH test was employed because ph is prone to changing depending on the change of protein. Each group of the standard solution, cpm (counter per minute), and the patient relative concentration values were compared by date, and Through the correlation coefficient and Paired t-test, the significant level of each group was analyzed. Results : ACTH, PTH, LH pH values were too subtle denaturation rather than numerical changes in the protein. In addition, when the standard solution of ACTH, PTH, LH was refrigerated, after 3 days and 7 days, there was a significant difference observed between the solution being kept in a refrigerator and a freezer within a significance level. Conclusion : Standard solution should be kept in a freezer, and being kept in a fridge, it is recommended to use the solution as soon as possible.

      • UBC 검사의 이상결과에 대한 연구

        박준모,유혜정,김한철,한걸순,Park, Jun Mo,Yoo, Hye Jung,Kim, Han Chul,Han, Geul Soon 대한핵의학기술학회 2013 핵의학 기술 Vol.17 No.2

        Purpose: As UBC IRMA is being tested, patients out of the reference value are reacting within the value again a few days later the urine collection tested, which causes the reliability of the test to decrease as a result. In this study, we can assume that the physiological changes in the factors would affect the results. The purpose of the study is to find out whether hematuria and proteinuria in the sample as well as the interval time (3 hours or more recommended) have affected the results. As a result, we could discover the changes in factors and increase the reliability of the test. Materials and Methods: 468 people (female: 249, male: 219) who came for the check-up were presented herein for medical examination from 2013.3.15 to 2013.1.2. Some people out of 468 who have reacted onto the reference value were divided into group low titer zone, ow-middle titer zone, and middle-high titer zone and tested for hematuria and proteinuria. During that period, 48 outpatients were asked to fill in a questionnaire regarding the urination interval time. The reagents used were (IDL Biotech AB, Sweden) and UBC IRMA. Results: Of the patients that are formed in the reference value of ($0.1-34.0{\mu}g/L$) turn out to be 52.7 years average age in their low concentration, ($mean{\pm}SD$) of the value of $0.10{\pm}0.02{\mu}g/L$. Among 80 people (50.8%, female: 49.2%), 16 patients (20%) have shown reaction to microscopic hematuria and 10 patients (12.5%) responded to proteinuria. In the average low concentration under 52.5 years of average age, 43 people (53%) have shown reaction to microscopic hematuria and 21 people (26.3%) are proteinuric patients out of 80 patients (male: 50.8%, female: 51.3%). In the middle high concentration of $11.8{\pm}4.82{\mu}g/L$ under the average age 51.7 years, 35 patients (53%) have responded to the microscopic hematuria and proteinuric patients are 26 people (39.3%) out of 66 people (men: 44%, women: 56%). In addition, in the concentration of $51.7{\pm}43.5{\mu}g/L$, some patients who get out of the reference value are observed as the average age of 52.0. 11 patients (78.6%) out of 14 (male: 35.7%, female: 64.3%) react to the microscopic hematuria. There show 6 people (42.8%) who turn out to be as proteinuric patients. As for the interval time, $1.67{\pm}3.71{\mu}g/L$ was the average value among 48 patients (female: 45.8%, male: 54.2%). Conclusion: We cannot see if proteinuria and hematuria directly affect abnormal results of inspection of 8,18 cytokeratin; however, we can find out that they statistically have an influence on highly generating UBC among several mechanisms. Also, although urination interval time was various every 15 minutes, we it does not affect these results.

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