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      • 메디컬 시험기관에서 측정 불확도의 중요성과 의의

        유소연,김년옥,임수연,윤태석,신용환,Yoo, Soh Yeon,Kim, Nyun Ok,Lim, Soo Yeon,Youn, Tae Seok,Shin, Yong Hwan 대한핵의학기술학회 2015 핵의학 기술 Vol.19 No.2

        Purpose Medical laboratories carrying out all types of measurement are increasingly being asked to evaluate the uncertainties associated with their measurement results. For medical laboratories, measurement uncertainty is now an accreditation requirement as specified by standard such as ISO/IEC 17025 and ISO 15189. In order to satisfy the level of 'accredited medical laboratory', we need to evaluate the measurement uncertainties and have to provide them to certification authority such as KOLAS. For this reason, we carried out processes of measurement uncertainties by using the real test examples. Materials and Methods We searched and arranged the terms associated with ISO 15189. The CA19-9 test results of three (A, B, C) hospitals accredited by KOLAS, was the object of the measurement uncertainty estimation. We evaluated type A and, B both uncertainty estimation methods. Type A evaluation is using the repeated measurement values, (bottom-up approach). Type B evaluation is not using statistical analysis, but doing another method such as variation coefficient of internal quality control materials (Top-down approach). Results Hospital A of the expanded uncertainty on CA19-9 control 1 was $27.0{\pm}5.11U/mL$, control 2 was $181{\pm}30.97U/mL$, that of hospital C was $41.22{\pm}7.56U/mL$(type A evaluation). By using the variation coefficient of intra quality control materials we could estimate the standard uncertainty, combined standard uncertainty, expanded standard uncertainty(k=2). The expanded uncertainty of A hospital was 10.7~15.8%, B hospital was 8.0~22.7%(type A evaluation). Conclusion Medical laboratories should require the estimation results of measurement uncertainties in compliance with ISO 15189. Then, we studied the concept and estimation process with real examples in measurement uncertainty and made an appropriate form to report. Medical laboratories accredited by KOLAS could evaluate measurement uncertainty by using type A and B. We need to make an effort to standardize our laboratories, which could be a chance to reduce the rate of misdiagnosis and improve the reliability in medical laboratories.

      • 설문조사를 바탕으로 부서 간 만족도 향상을 위한 개선 안

        박지혜,김년옥,서미혜,유소연,박혜미,Park, Ji-Hye,Kim, Nyeon-Ok,Seo, Mi-Hye,Yoo, Soh-Yeon,Park, Hye-Mi 대한핵의학기술학회 2017 핵의학 기술 Vol.21 No.1

        Purpose Recently, there has been increasing demands for clinical departments at Asan Medical center in Seoul. They want to see the results of lab tests about blood samples as soon as possible and to be reported to them on the day. As the main contents of the survey, we explained the goodness of Asan medical center's in vitro and the points to be improved. Based on this, it became an opportunity to create a positive image of In vitro laboratory. In addition, we could identify their specific requirements through the surveys. Materials and Methods In September 2016, a total of 14 questionnaire surveys were conducted for 49 clinical departments and outpatient nurses at Asan Medical center in Seoul. The survey consists of description questions to be able to express the intention of the individual and the questions made on the Likert 4 point scale. The main contents of 14 questions are composed of goodness of In Vitro laboratory and points to be improved. Results 62% answered that the best service in In Vitro laboratory was "good accuracy and reproducibility". On the other hand, as an inconvenience when requesting blood tests, 73% pointed out that "the result report time was long", which was recognized as a part to be improved. There are many contents that "The result of all tests is reported within 2 hours" on the day of the examination. In the question - 'Are there some examination results which do not coincide well with clinical observations?', 55 of 56 people answered "no". Above all, the majority answered that waiting for re-examination results is too long. This problem must be causing discomfort to the patients. Conclusion In order to improve these problems, the first thing is to increase the number of blood tests by using the current personnel, equipments and reagents to the fullest by item in Asan Medical Center's Nuclear medicine in vitro part. Secondly, in case of re-examinations, we use the "AMIS message" to show other clinical departments the reporting time. This methode improves the efficiency of work with nurses and increases satisfaction of custom service. Thirdly, the correlation was evaluated by selecting the test species that can be carried out by the shortening method. Currently, C-peptide and insulin are implemented in the reaction process to shorten 2 hours into 1 hour. Finally, we are considering purchasing new equipments for quick test results.

      • 제안제도를 활용한 RIA 발전 방향에 관한 연구

        신영균,천준홍,김년옥,이선호,김성호,유선희,Shin, Young-Kyun,Chun, Jun-Hong,Kim, Yeon-Ok,Lee, Seon-Ho,Kim, Seong-Ho,Yoo, Seon-Hee 대한핵의학기술학회 2011 핵의학 기술 Vol.15 No.1

        기존에는 제안 내용을 검사 담당자가 필요에 의해 개인적으로 process개선을 하였다. 그러나 최근 병원에서 정책적으로 제안제도 활성화를 다양한 방법으로 추진하고 있어 핵의학과 혈액검사실에서도 체계적인 system이 대두 되었다. 이에 핵의학과 혈액검사실에도 제안제도를 활용하여 업무개선이 활성화 되었고 더 나아가 우수제안 사례를 타 병원과 공유하여 RIA 발전에 도움을 추구하고자 한다. 2007년 1월부터 2010년 3월까지 혈액검사실에서 제안한 총 124건의 제안내용을 분석하였다. 연구방법은 제안한 내용을 고객만족, 원가절감, 실험 방법개선, 장비, 환경개선, 전산 등으로 나누어 분석 하였다. 총 124건의 제안 내용 중 환경개선과 전산에 관한 제안이 각 33건씩으로 26.6%를 차지하였고, 고객만족에 관한 제안이 32건으로 약 25.8%를 차지 하였다. 그 중 우수제안 내용은 다음과 같다. 1. RIA-MAT280(핵의학 혈액검사 자동화 기기) washing part 소모품 제작에 따른 기기운용 효율성 증진 및 원가절감 방안 2. Fitting system을 이용한 aspiration line의 개선 및 유지보수 개선방안 3. 자동분주기기(automatic dispensing system, Hamilton) waste bottle cap개조를 통한 액체 폐액 관리 개선방안 4. Hamilton System을 이용한 검사용 검체 분주 시 error방지를 위한 개선방안 5. Air regulator를 이용한 측정성분 dry개선방안 6. 검사코드 순서 배열 수정에 의한 건별결과 입력 error 감소 방안 7. 접수시간 스티커 발행으로 재검사 수행할 모 검체 찾는 시간 단축방안 8. Hamilton 장비 QC 보안으로 정확도 향상 제안제도를 통해 관리자부터 검사실 직원에 이르는 업무개선 의식의 활성화를 유도하고, 전사적인 업무개선 시스템을 확보함으로써 일반직원에게도 아이디어의 생산 및 체계화를 유도할 수 있었으며, 나아가 실질적인 업무개선 효과를 통해 병원경쟁력을 높이고 병원 발전을 도모 하였다. Purpose: Until now, the process was improved by the needs of experimenters personally. But recently, suggestion system in hospital has been activated in various ways. So the department of nuclear medicine laboratory is also aware of the need of operation improvement using suggestion system. It is intend to assist in the development by sharing excellent suggestion cases with other hospitals. Material & Method: A total of 124 suggestion cases from January 2007 to March 2010 were analyzed. Suggestion cases were divided into customer satisfaction, cost reduction, improved testing methods, equipment, environmental improvement, and computational system. Result: Suggestion cases of environmental improvement and computational system were accounted for 26.6% as 33 cases, respectively. Suggestion for customer satisfaction is 25.8% as 32 in a total of 124 cases. Conclusion: Activation of the awareness of operation improvement is induced by suggestion system. By securing system of operation improvement, employees' ideas can lead to the production and systematization. Furthermore, it enhances hospital competitiveness and promotes the development of the hospital.

      • Thyroglobulin 검사의 반응조건에 따른 결과 비교 분석

        정승희,이영지,문형호,유소연,김년옥,Joung, Seung-Hee,Lee, Young-Ji,Moon, Hyung-Ho,Yoo, So-yoen,Kim, Nyun-Ok 대한핵의학기술학회 2017 핵의학 기술 Vol.21 No.1

        Thyroglobulin (Tg)은 갑상선에서 특이적으로 생성되는 요오드단백질로써 분화갑상선 암(Differentiate Thyroid Carcinoma, DTC) 의 생물학적 표지자이다. 본 검사실의 Tg 검사법은 반응시간이 길어 진료과와 환자들의 결과보고 요청사항을 만족시키지 못하고 있는 상황이다. 이를 만족시키기 위해 Tg 검사의 반응시간을 단축하고자 현재 사용중인 B사 Kit와 타 병원에서 사용중인 C사 Kit의 반응시간을 단축시켜 실험을 진행하였다. 본원에 의뢰된 Tg 약 65명의 환자 검체를 대상으로 B사 Kit의 반응시간을 $37^{\circ}C$ shaking 2hr/2hr, 실온 shaking 3hr/2hr, $37^{\circ}C$ shaking 1hr/1hr으로, C사 Kit의 원법인 실온 shaking 3hr법과 반응시간을 단축한 실온 shaking 2hr, $37^{\circ}C$ shaking 2hr 방법으로 단축하여 기존에 시행하던 overnight법과 상관성검사를 실시하여 비교하였다. 그 결과 여섯가지 방법 모두 1.0 ng/mL 이상의 값에서는 높은 상관관계를 보였으나 1.0 ng/mL 이하의 값에서는 다소 흔들리는 경향이 있었다. 하지만 그 중 상대적으로 안정적이었던 B사 Kit $37^{\circ}C$ shaking 1hr/1hr 법과 C사 Kit 실온 shaking 2hr 법에 대해 다른 조건들을 재설정하여 적합한 방법을 찾는다면 진료과와 환자들의 요구 사항 충족은 물론, EIA법과의 경쟁력 면에서도 유용할 것이다. Purpose Thyroglobulin (Tg) is a biologic marker of differentiated thyroid carcinoma (DTC), produced by normal thyroid tissue or thyroid cancer tissue. Therefore, the Tg values of DTC patients is the most specific indicator for judging whether recurrence occur or whether the remaining thyroid cancer is present. Thyroid cancer is currently the most common cancer in Korea, of which 90% is differentiated thyroid cancer. The number of patients with thyroid disease of this application also increased, and an accurate and prompt results are required. However, the incubation time of the Tg commonly takes about 24 hours in our hospital, and the result reporting time is delayed, and We could not satisfied with the requirements of clinical departments and patients. In order to fulfill these requirements, experiments were conducted by shortening the incubation time between company B's Kit currently in use and company C's Kit used in other hospitals. Through these experiments, we could perform the correlation with the original method and shortening method, and could find the optimum reaction time to satisfy the needs of the departments and the patients, and we will improve the competitiveness with the EIA examination. Materials and Methods In September 2016, we tested 65 patients company B's kit and company C's kit by three incubation ways. First method $37^{\circ}C$ shaking 2hr/2hr, Second method RT shaking 3hr/2hr, Third method 1hr/1hr shaking at $37^{\circ}C$. Fourth method RT shaking 3hr method which is the original method of Company C's Kit. Fifth method, the incubation time was shortened under room temperature shaking 2hr, Sixth method $37^{\circ}C$ shaking 2hr. And we performed and compared the correlation and coefficient of each methods. Results As a result of performing shortening method on company B currently in use, when comparing the Original method of company B kit, First method $37^{\circ}C$ shaking 2hr/2hr was less than Tg 1.0 ng/mL and the ratio of $R^2=0.5906$, above 1.0 ng/mL In the value, $R^2=0.9597$. Second method RT shaking 3hr/2hr was $R^2=0.7262$ less than value of 1.0 ng/mL, $R^2=0.9566$ above than value of 1.0 ng/mL. Third method $37^{\circ}C$ shaking 1hr/1hr was $R^2=0.7728$ less than value of 1.0 ng/mL, $R^2=0.8904$ above than value of 1.0 ng/mL. Forth, Company C's The original method, RT shaking 3hr was $R^2=0.7542$ less than value of 1.0 ng/mL, and $R^2=0.9711$ above than value of 1.0 ng/mL. Fifth method RT shaking 2hr was $R^2=0.5477$ less than value of 1.0 ng/mL, $R^2=0.9231$ above than value of 1.0 ng/mL. Sixth method $37^{\circ}C$ shaking 2hr showed $R^2=0.2848$ less than value of 1.0 ng/mL, $R^2=0.9028$ above than value of 1.0 ng/mL. Conclusion Samples with both values of 1.0 ng/mL or higher in both of the six methods showed relatively high correlation, but the correlation was relatively low less than value of 1.0 ng/mL. Especially, the $37^{\circ}C$ shaking 2hr method of company C showed a sharp fluctuation from the low concentration value of 1.0 ng/mL or less. Therefore, we are planning to continuously test the time, equipment, incubation temperature and so on for the room temperature shaking 2hr method and $37^{\circ}C$ shaking 1hr/1hr of company C which showed a relatively high correlation. After that, we can search for an appropriate shortening method through additional experiments such as recovery test, dilution test, sensitivity test, and provide more accurate and prompt results to the department of medical treatment, It is competitive with EIA test.

      • 모집단 분포를 이용한 핵의학 혈액검사의 통계적 품질관리의 유용성

        천준홍,조은빛,유선희,김년옥,Cheon, Jun Hong,Cho, Eun Bit,Yoo, Seon Hee,Kim, Nyeon Ok 대한핵의학기술학회 2016 핵의학 기술 Vol.20 No.1

        정도관리(Quality Control)는 오차를 최소한으로 하여 검사의 신뢰도를 증진 시키는 것을 목적으로 하고 있으며 이러한 정도관리 활동을 통해 환자의 진단과 치료방침에 영향을 주는 핵의학 혈액 검사의 신뢰도가 확보되고 있다. 이에 연구자들은 신뢰도 향상의 추가적인 기법으로 건강검진 수검자를 대상으로 시행한 핵의학 혈액검사의 모집단 분포를 이용한 통계적 품질관리의 유용성을 평가해 보고자 한다. 2014년 1월부터 2014년 12월까지 서울아산병원 건강증진센터를 이용한 건강검진 수검자 41,341명을 대상으로 핵의학 혈액 검사 12종목에 대해 통계 분석을 시행 하였다. 통계분석은 핵의학 혈액 검사 12종목에 대한 결과 보고 치를 참고치 이내, 참고치 이상, 참고치 이하의 세 가지 그룹의 월간 백분율로 구분하여 모집단 분포의 평균값과 표준편차, 그리고 표준편차 지수(Standard Deviation Index: SDI)를 산출 하였고 그 결과 모집단 분포의 표준편차는 모든 그룹에서 대부분 ${\pm}2SD$ 이내의 결과를 보였다. 건강검진 수검자에 대한 핵의학 혈액검사 12종목(AFP, CEA, CA19-9, CA125, PSA, TSH, FT4, Anti-Tg-Ab, Anti-TPO-Ab, Calcitonin, 25-OH-VitD3, Insulin)의 모집단 분포를 분석한 결과 월간 백분율의 표준편차 지수(SDI)가 ${\pm}2.0$ 이상인 경우는, 1월과 3월 Insulin검사에서 각각 2.3, 2.4, 5월 Anti-Tg-Ab검사에서 2.2, 그리고 9월 CA19-9에서 2.2의 결과를 보였다. 이는 검사 Kit 시약의 이상 (동위원소 시약의 최대 결합률 저하), 검사반응 시간의 저하가 원인 이었다. 연구대상이 되는 전체의 속성을 포함하고 모집단 분포의 특성을 이용한 통계적 품질관리는 검사실에서 시행하고 있는 내부정도관리 프로그램을 보완하는 역할을 할 수 있으리라 생각된다. Purpose The importance of quality control by the error to a minimum, which for the purpose of enhancing the reliability of the examination is not be emphasized excess. Currently, most nuclear medicine laboratory are conducting the internal and external quality control, and they are applying the Levey-Jennings or Westgard Multi-Rules by using the commercialized quality control materials. The reliability of the nuclear medicine blood test which affects the diagnosis of patients and the treatment policy is being secured through this quality control activity. Therefore, researchers will evaluate the utility of the statistic quality control using the population distribution of the nuclear medicine blood test conducted targeting the checkup examinees by the additional technique of the reliability improvement. Materials and Methods A statistic analysis was performed about 12 items of the nuclear medicine blood test targeting 41,341 peoples who used the health screening and promotion center in Asan Medical Center from January, 2014 to December, 2014. The results of 12 items of the nuclear medicine blood test was divided into the monthly percentage of three groups: within reference values, over reference, and under reference to analyze the average value of the population distribution, standard deviation, and standard deviation index (SDI). Results The standard deviation of the population distribution mostly showed a result within ${\pm}2SD$ in all groups. However, When the standard deviation of the population distribution represented a result over ${\pm}2SD$, it was confirmed SDI was showing a result of SDI > -2 or SDI > 2. As a result of analyzing the population distribution of 12 items(AFP, CEA, CA19-9, CA125, PSA, TSH, FT4, Anti-Tg-Ab, Anti-TPO-Ab, Calcitonin, 25-OH-VitD3, Insulin) of the nuclear medicine blood part basic test, when SDI of the monthly percentage which deviated from the reference values was over ${\pm}2.0$, CA19-9 September was 2.2, Anti-Tg-Ab may was 2.2, Insulin January was 2.3, Insulin March was 2.4. It was confirmed these cases were attributed to the abnormality of the test reagent (maximum combination rate of isotope reagent declined) and the decline of the test response time. Conclusion The population distribution includes the entire attribute which becomes the study object. It is expected the statistic quality management using the population distribution which was conducted targeting the checkup examinees by dividing into three groups: within reference values, over reference, and under reference by means of this characteristics will be able to play a role of complementing the internal quality control program which is being carried out in the laboratory.

      • OCS QC 프로그램을 통한 건진 센터 종양검사의 결과보고 개선

        백송란,김성호,유소연,김년옥,문형호,유선희,조시만,Back, Song-Ran,Kim, Sung-Ho,Yoo, So-Yeon,Kim, Nyun-Ok,Moon, Hyoung-Ho,Yoo, Seon-Hee,Cho, Shee-Man 대한핵의학기술학회 2009 핵의학 기술 Vol.13 No.3

        목적 : 건진센터 종양 검사가 정상범위 내에서 재검기준이 명확히 설정되어 있지 않아 검사자마다 각자의 재검기준에 따라 재검을 시행함에 따라 재검상의 편차가 크고 일괄적이지 못했다. 이를 개선하기 위해 정상치이하값에서의 재검기준을 마련하고 정상치이하인 값에서 trend 결과를 관리할 수 있는 본원 OCS QC (order communication system quality control)프로그램을 이용하여 건진 센터 종양 검사의 결과보고오류에 개선을 하고자 한다. 대상 및 방법 : 2009년 2월부터 3월까지 본원 건진 센터에서 종양 검사(AFP, CEA, CA19-9, CA125, PSA)를 실시한 환자들을 대상으로 하였다. 우선 각 검사의 정상범위에서 Inter assay CV%를 구하여 screening 기준 값을 설정하였다. OCS QC program에 진료과, 대상 검사종목, screening 기준 값을 입력하여 기준 값에 벗어난 결과는 색깔에 반전을 주었다. 1차로 5가지종양 검사를 전 결과대비 ${\pm}$ 30% 기준을 벗어난 screening 건수를 구하였고 2차로 각각의 종양 검사에 대해 전 결과 대비 AFP는 ${\pm}$ 60%, CEA와 CA19-9는 ${\pm}$50%, CA125와 PSA는 ${\pm}$40%로 기준 값을 상향조정하여 screening 건수를 구하였으며 정상치 이하에서의 재검기준도 설정하여 비교하였다. 결과 : 1차 screening 건수 백분율은 30~40%의 결과를 얻었고, 2차 screening 건수 백분율은 AFP 26.1%, CEA 18.9%, CA19-9 17.3%, CA-125 18.7%, PSA 21.0%로 평균 20%의 screening 백분율을 얻었다. 정상치 이하에서의 재검기준은 AFP 5.0이하$\leftrightarrow$10.0이상, CEA 1.0이하$\leftrightarrow$3.0이상, 2.0이하$\leftrightarrow$4.0이상, CA19-9와 CA-125 10.0이하$\leftrightarrow$30.0이상, PSA 1.0이하$\leftrightarrow$2.0이상으로 정하였으며 평균 20.4%의 screening 백분율에 재검기준을 적용시켜 실제 재검사 건수를 얻었다. 2달 동안 재검사 건수는 AFP 0건, CEA 15건, CA19-9 3건, CA-125 2건, PSA 5건이었다. 결론 : OCS QC 프로그램을 이용하여 시스템적인 재검기준을 마련함으로 검사자간 재검 실시 편차의 감소가 있었고 정상치 이하 값에서 결과보고오류에 대해 개선이 있을 것으로 사료된다. Purpose: Standard of retests were discrepant and inconsistent due to inaccuracy and lack of standardization within normal range limit of tumor marker test. To enhance the standardization of retests set standard value below normal range and the Order Communication System Quality Control (OCS QC) program was put in place. This program enables managing the results within lower limit of normal range which were used for tumor marker test in Health Center. Materials and Methods: At present the tumor marker study for AFP, CEA, CA19-9, CA125, and PSA included outpatients in Asan Medical Center from February to March, 2009. The standard value was obtained by using the percentage of CV of Inter Assay according to the normal range of each tumor test. The results were confirmed by using the OCS QC program via formatted assessment of screening test such as test items, standard value and medical department. The number of out-of-range results within plus and minus 30 percents regarding the five primary items of tumor marker test was assessed. The next step was to obtain the number of AFP, CEA, and CA125 according to the ratio of comparison between prior and post test result, 60%, 50%, and 40% within normal range, respectively. In addition, set standard value below normal range. Results: The first screening test with percentage of sample number was resulted between 30%-40% and the second one was AFP 26.1%, CEA 18.9%, CA19-9 17.3%, CA125 18.7%, and PSA 21.0% obtained screening percentage of average 20 percents. The limited value of retest was AFP less than 5.0 and more than 10.0, CEA less than 1.0 and more than 3.0, CA19-9 less than 10.0 and more than 30.0, and PSA less than 1.0 and more than 2.0 to set and the number of retest was obtained by applying to the limited value of retest to screening percentage of average 20 percents For two months, the number of retest was AFP 0, CEA 15, CA19-9 3, CA125 2, and PSA 5. Conclusions: Through using the OCS QC program in establishing the standard of retest systemically, there appeared to be reduced discrepancy among the examiners and to be expected improvement in relation to the error of results.

      • TSH, FT4 검사의 Two-point Calibration Curve 적용의 유용성 평가

        박혜미,유선희,이선호,김년옥,Park, Hye-Mi,Yoo, Seon-Hee,Lee, Seon-Ho,Kim, Nyun-Ok 대한핵의학기술학회 2016 핵의학 기술 Vol.20 No.2

        Purpose The ASAN Medical Center, Nuclear Medicine performs TSH (Thyroid stimulating hormone) and FT4 (Free Thyroxine) tests 8 times per day. Accordingly, 70 ~ 80 kit tubes are consumed every day for the measurements and the time consumed for reagent dispensing averages over 170 seconds, where the TAT (turnaround time) may be effected when the number of test samples is larger than expected. Therefore, the following test was conducted with the purpose to reduce the number of kit tubes consumed, and reduce the time for reagent dispensing. Materials and Methods The test is based on applying the same reagent for tests where the number of samples is 30 or less. The test for TSH was conducted 9 times from July $1^{st}$ 2015 to July $10^{th}$ 2015. The test for FT4 was conducted 4 times from June $18^{th}$ 2015 to June $22^{nd}$, 2015. Standard Solution No.2 (0.153 uU/mL) and No.5 (4.96 uU/mL) was selected as the two-point standards for the TSH test, and Standard Solution No.3 (0.777 ng/dL) and No.4 (2.044 ng/dL) was selected as the two-point standards for the FT4 test. 38 test samples were subject to correlation analysis. Results For TSH, the result of the normal test shows ranges of 0.20 ~ 0.37 uU/mL for Control1, 0.53 ~ 0.71 uU/mL for Control2, and 6.77 ~ 7.94uU/mL for Control3, while the result of two-point calibration curve test shows ranges of 0.18 ~ 0.27 uU/mL for Control1, 0.53 ~ 0.71 uU/mL for Control2, and 7.30 ~ 8.52 uU/mL for Control3. For FT4, the result of the normal test shows ranges of 0.85 ~ 0.94 ng/dL for Control1 and 4.23 ~ 4.57 ng/dL for Control2, while the result of two-point calibration curve test shows ranges of 0.61 ~ 0.75 ng/dL for Control1 and 3.88 ~ 5.71 ng/dL for Control2. For TSH, the CV% of the normal test for Control1, Control2 and Control3 are 10.5, 3.3 and 3.6 respectively, while the CV% of the two-point calibration curve test for Control1 and Control1 are 12.4, 8.2 and 5.1 respectively. The result shows an outstanding correlation of TSH: y = 0.9985x - 0.0459 $R^2=0.9986$. For FT4, the CV% of the normal test for Control1 and Control2 are 0.70 and 0.71 respectively, while the CV% of the two-point calibration curve test for Control1 and Control1 are 8.7 and 16.2 respectively. The result shows an outstanding correlation of FT4: y = 1.2674x - 0.1133 $R^2=0.9824$. Conclusion The two-point calibration curve can be efficiently applied for TSH in cases where the number of test samples is not large, since the number of samples to be re-tested increases when the result is abnormal from the calibration curve. The two-point calibration curve test should not be applied for FT4 where the results do not consistently comply with the quality assessment range. Depending on how the two-point calibration curve is applied, up to 5 test tubes can be conserved per test, and the reduced time for reagent dispensing is anticipated to have a positive effect on the TAT (turnaround time).

      • Ultrasensitive serum thyroglobulin의 유용성 평가

        이선호,조은빛,신영균,이영지,유선희,김년옥,Lee, Sun Ho,Cho, Eun Bit,Shin, Young Kyun,Lee, Young Ji,Yoo, Seun Hee,Kim, Nyun Ok 대한핵의학기술학회 2015 핵의학 기술 Vol.19 No.2

        Purpose Serum Thyroglobulin measurement is a major tool for the follow-up of differentiated thyroid cancer (DTC) patients. Thyroglobulin is Normal thyroid tissue, or thyroid cancer tissue produced only. Thyroid hormone to a halt without Tg differentiation of thyroid cancer recurrence just by measuring how to decide whether there was increasing expectations if I can do it instead. Therefore, in excellent sensitivity Tg new inspection of the functional sensitivity by measuring the looked to evaluate the usefulness of reagents. Thyroidectomy is measuring the numbers Tg (total thyroidectomy) remaining thyroid ablation and radioactive iodine (radioactive iodine remnant ablation, RRA) DTC in patients being diagnosed with or help predict the remaining early detection of thyroid cancer recurrence. Materials and Methods Agent that I'm currently using Tg of the measurements of low clinical specimen for a second drainage of the three (0.08 0.17, 0.98, ng/mL) within the scope of the dilute magnification (2, 4, 8, 16, 32 times) by dilute Intraassy (n=10) and Interassay (n=10) out in no time. Concentration value according to the coefficient of variation and the mean and standard deviation of each measurement (Coefficient of variation, CV) the absolute value of the measured values that corresponds to 20 percent target a coefficient of variation of CV Find the value of the concentration of the functional sensitivity measurement did. Also, analytical sensitivity with recovery rates, Dilution test inspections, and interrelationship, compared. Results Sensitivity is an excellent analytical sensitivity within the prosecutor kit Tg 0.006 ng/mL, and core analytical sensitivity, conducted by the 0.006 ng/mL to same conclusion. Be rather high to 142 percent recovery rate was 60 to measurement and functional sensitivity, 0.01766 ng/mL(Intraassay n=10) was measured at. CBC is relatively good correlation as ($R^2=0.949$) the correlation. Conclusion Recently ultrasensitive thyroglobulin this clinically important indicators of the previous kit and demands are lower than sensitivity to the measurement results. Therefore, ultrasensitive thyroglobulin test is correlated that there would be useful in value in nuclear medicine the thyroid gland.

      • KCI등재

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