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.

아세틸콜린 수용체 항체(Acetylcholine receptor autoantibody) 검사의 의의

유소연,임수연,백송란,서미혜,문형호,유선희,Yoo, Soh-Yeon,Lim, Soo-Yeon,Pack, Song-Ran,Seo, Mi-Hye,Moon, Hyung-Ho,You, Sun-Hee 대한핵의학기술학회 2011 핵의학 기술 Vol.15 No.1

아세틸콜린 수용체는 아세틸콜린에 대한 신경근 접합부의 수용체로 중증 근무력증에서는 이 수용체에 대한 자가항체인 아세틸콜린 수용체 항체가 생산되어 수용체 단백질과의 사이에 항원항체 결합체를 형성하기 때문에 신경흥분의 전달장애를 가져오는 것으로 알려져 있어 아세틸콜린 수용체 항체의 측정은 중증 근무력증의 진단에 중요하다. 중증 근무력증(Myasthenia Gravis)은 근육의 힘이 비정상적으로 약해지거나 피로해지는 병으로 안검하수, 복시, 근력약화 등을 나타내는 자가 면역성 질환이다. 모든 근무력증 환자에서 이 자가항체가 존재하는 것은 아니고, 전신성 근무력증 환자의 80~90% 가량이 발견되며 안근육에 국한된 근무력증의 71%가 검출된다. 그러나 선천성 근무력증에서는 검출되지 않는다. 아세틸콜린수용체 항체 농도와 임상적 중증도와의 상관관계는 없는 것으로 알려져 있다. 본 연구에서는 아세틸콜린 수용체 항체의 검사법을 소개함으로서 중증 근무력증의 진단에 유용한 정보를 제공하고자 하였다. 대상은 본원에 내원한 환자들 중 2010년 8월부터 9월까지 총 19명의 아세틸콜린 수용체 항체 검사가 의뢰된 검체를 대상으로 검사를 시행하였고, 측정키트는 R사의 키트로 면역침강법(immuno-precipitation)을 이용한 비경쟁반응법이다. cut off 값은 0.2 nmol/L로 결과값 중 음성값(negative)은 0.2 nmol/L미만이며, 양성값(positive)은 0.2 nmol/L 이상으로 판정한다. 검사를 시행한 19명의 환자 중 7명이 양성으로 보고되었으며(36.8%), 7명 중 6명이 근무력증(MG)으로 진단되었다. 중증 근무력증의 확진에는 이 검사법뿐만 아니라 다른 여러 가지 추가 검사들이 필요하다. 희귀병을 진단하는 검사법이라 많이 보편화된 검사는 아니지만 중증 근무력증은 아세틸콜린 수용체에 대한 항체가 생겨서 기능장애를 초래하는 질병이기 때문에 이 항체의 측정은 그의 진단에 유용할 것이라고 사료된다. Purpose: Acetylcholine receptor antibodies cause acetylcholine receptor loss, which is responsible for failure of the neuromuscular junction in the acetylcholine receptor autoantibody. The disease characterized by muscle weakness and fatigue, myasthenia gravis(MG) occurs when the body inappropriately produces antibodies against acetylcholine receptors, and thus inhibits proper acetylcholine signal transmission. And this reason, the measurement of acetylcholine receptor antibodies can be of considerable value in disease diagnosis. Methods: From 2010. August to September, we tested orderd AchRAb 19 samples to get the results. 1. Pipette $5{\mu}{\ell}$ undiluted patient sera and kit control and add 125I AChR $50{\mu}{\ell}$ and incubate at R.T for 2 hours. 2. Pipette $50{\mu}{\ell}$ of anti-human IgG into each tube, and incubate at $2{\sim}8^{\circ}C$ for 2 hours. 3. Pipette $25{\mu}{\ell}$ precipitation enhancer into each tube and add 1mL washing solution into all tubes. 4. Centrifuge each tube for 20minutes at $2{\sim}8^{\circ}C$ at 1500g. 5. Aspirate or decant the supernatant. 6. Pipette 1 mL washing solution into all tubes and resuspend the pellet and repeat centrifugation. 7. Aspirate or decant the supernatant and count all tubes on a gamma counter. Results: Cut off value is 0.2 nmol/L and the results taken below 0.2 nmol/L are negative, the results above that identified as being positive values. We assayed the 19 patients samples and got 7 positive results. Of which, 6 patients were diagnosed as MG.(85.7%). Conclusions: Acetylcholine Receptor autoantibody test is intended for use by persons only for the quantitative determination of it in human serum. Even if measurement of the antibodies is not a routine test, it can be of considerable value in disease diagnosis.

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.

25-Hydroxyvitamin D3 RIA Kit(3H, 125I)의 비교 및 평가보고

정윤영 ( Yoon Young Chung ),임수연 ( Soo Yeon Lim ),신영균 ( Young Gyun Sin ),천준홍 ( Joon Hong Cheon ),김년옥 ( Nyeon Ok Kim ),유소연 ( Soh Yeon Yoo ) 대한임상검사과학회 1997 대한임상검사과학회지(KJCLS) Vol.29 No.1