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국가 표준물질을 이용한 B형 간염 검사 시약 간의 결과 비교 (The Comparison of Results Among Hepatitis B Test Reagents Using National Standard Substance)

  • 이영지;심성재;백송란;서미혜;유선희;조시만
    • 핵의학기술
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    • 제14권2호
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    • pp.203-207
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    • 2010
  • B형 간염은 B형 간염 바이러스(Hepatitis B virus ; HBV)에 의해 일어나는 감염으로 B형 간염 검사는 현재 여러 가지 검사 방법과 여러 종류의 Kit, 장비로 시행되고 있는데, 이에 따라 검사 결과간의 차이가 있을 수 있다. 이러한 차이를 관리하기 위해서는 특정 표준물질을 이용하여 검사시약, 검사 시스템의 성능을 평가하는 과정이 필요하다. 본 연구는 B형 간염 검사 국가 표준물질을 이용하여 여러 다른 검사법 시약과 비교 실험을 통해 본원 핵의학과에서 사용하고 있는 RIA법 시약이 동일한 결과로 정확하게 수행되고 있는지를 알아보는데 있다. 실험에 사용된 B형 간염 검사에 대한 식품의약품안전평가원의 생물의약품 국가 표준물질은 총 5가지로 항원물질 4가지와 항체물질 1가지로 구성 되어 있다. "B형 간염 바이러스표면 항원(혼합농도패널)", "B형 간염 바이러스 표면 항원(저농도 패널)", "B형 간염 바이러스 표면 항원 86.76 IU/vial", "B형 간염 사람 면역글로불린 95.45 IU/vial", "B형 간염 바이러스 표면 항원 표준물질 0.02~11.52 IU/mL"이며, 이를 본원에서 사용하고 있는 A사, B사 두 종류의 시약으로 각각 검사 방법에 따라 실험하였다. 보다 정확한 결과를 산출하기 위해 위의 모든 실험은 반복 측정하였다. "B형 간염 바이러스 표면 항원 (혼합농도패널)"은 S/CO단위를 기준으로 RIA법을 EIA 3가지 시약, CIA 2가지 시약과 비교한 일치율이 A사는 94.4%(17/18), 83.3%(15/18), B사는 88.9%(16/18), 77.8%(14/18)였다. "B형 간염 바이러스 표면 항원 (저농도 패널)" 의 결과 EIA 2가지 시약은 7개, CIA 3가지 시약은 11개가 양성 결과를 보였고 RIA법 A사는 3개, B사는 2개가 양성 결과를 보였다. 희석검사를 시행한 "B형 간염 바이러스 표면 항원 86.76 IU/vial"에서는 A사 시약은 600배(0.14 IU/mL), B사 시약은 300배(0.29 IU/mL)까지 양성 결과를 나타냈다. "B형 간염 사람 면역글로불린 95.45 IU/vial"의 경우에서는 A사 Kit는 10,000배(9.5 mIU/mL), B사 Kit는 4,000배(24 mIU/mL)까지 양성 결과를 보였다. "B형 간염 바이러스 표면 항원 표준물질 0.02~11.52 IU/mL"에 대한 실험 결과A사 시약은 0.38 IU/mL, B사 시약은 2.23 IU/mL 농도까지 검출하여 그 이상의 농도에서 양성 결과를 나타냈다. B형 간염 검사에 대해 국가 표준물질을 통해 비교해 보았을 때 여러가지 검사법 시약과 RIA 법 시약의 결과값 경향이 동일한 성향으로 나타나고 있으며, B형 간염 항원, 항체에 대한 역가 시험의 부분에 있어서도 항원은 최대 600배(0.14 IU/mL), 항체는 최대 10,000배(9.5 mIU/mL)까지 양성 결과를 얻을 수 있었다. 따라서 본원 핵의학과에서 시행 하고 있는 RIA 방법을 통한 B형 간염 검사의 검사시약과 검사시스템은 원활한 성능으로 정확한 결과보고가 수행되고 있다고 판단된다. 하지만 저농도 패널에서 다른 검사법 시약과의 낮은 일치율은 위양성과 민감도의 측면에서 해결되어야 할 숙제로 보이며, 또한 동일한 RIA 방법 일지라도 Kit간 민감도와 특이도의 격차는 계속해서 연구되고 개발 되어야 할 것으로 사료된다.

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자동차회사 근로자를 대상으로 한 근골격계 자각증상과 moire 영상 진단과의 관계 연구 (Research on the Relation between Musculoskeletal symptoms and Diagnosis using Moire Topography among Workers at an Automobile Manufacturing Plant)

  • 천은주;이영길;장두섭;이기남;송용선
    • 대한예방한의학회지
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    • 제5권2호
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    • pp.69-92
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    • 2001
  • The purposes of this study were to offer foundation making more certain standards of musculoskeletal disorder diagnosis, We researched musculoskeletal symptoms degrees, frequencies, and cares and then examined relation between musculoskeletal symptoms and diagnosis of musculoskeletal conditions using moire topography among workers at an automobile manufacturing plant. Therefore we propose the possibility of moire topography as diagnosing utilities of musculoskeletal disorders. Methods: This study was to examine the general characteristics, complaints of musculoskeletal symptoms, and work-related musculoskeletal disorder rates of cervicobrachial and lumbar area by survey among 435 workers at an automobile manufacturing plant and then to show each frequency and percentage, In the diagnosis using moire topography, we studied pain control necessity of cervicobrachial and lumbar area, 435 subjects were classified by 5 levels: A(no symptoms), B(need management), C(need treatment) and then more divided by B1(light symptoms)/B2(heavy symptoms), C1(light symptoms)/C2(heavy symptoms), And musculoskeletal areas were divided by 2 parts, cervicobrachial area(neck, shoulder, arm&elbow, and wrist&hand) and lumbar area, Then, frequency and percentage of each musculoskeletal areas(cervicobrachial and lumbar area) were appeared. At last, Pearson's chi-square test analysis was utilized to observe the relation between diagnosis using moire topography and general characteristics and the relation between diagnosis using moire topography and work-related complaint of musculoskeletal symptoms of cervicobrachial and lumbar area, Results: The subjects employed for this research were categorized into; by gender, all of them were males(l00%): by age, under 35 years 12 %, 36-40 years 56.3%, 41-45 years 26.3 %, and above 46 years 5.3% with 36-40 years accounting for most of it. By living location, owned houses represented 69.7%, rented houses 23.4%, monthly-rented 1.6%, the others 5.3%; by education, middle school and lower represented 3.0%, high school 89.4%, and junior college and higher 7.6% with high school occupying most of the group. By marital status, married represented 95.2%, unmarried 4.1%, and the others 0.7% with most of them married; by alcohol, drinking represented 81.8% and non-drinking 18.2%; by smoking status, smoking represented 53.6%, non-smoking 46.4% with no big difference between them. By working time(hours/week), below 50 represented 26.9%, 50-60 67.6%, above 60 5.5%; by working time(hours/day), below 9 represented 21.6%, 10-12 73.1%, above 13 5.3%; by job tenure(years), below 10 represented 25.1%, 11-15 54.3%, 16-20 15.2%, above 21 5.5%. By personal income per year, below 30 million won represented 11.0%, 30-40 84.8%, above 40 4.1%; by sleeping hours, below 6 hours represented 26.7%, 7-8 hours 69.9%, above 9 hours 3.4%. Complaint rates of musculoskeletal symptoms and work-related musculoskeletal disorder rates were 63.9% and 54.9% with shoulder area occupying most of both them. By pain degree of musculoskeletal symptoms, shoulder area represented $2.73{\pm}0.84$, lumbar area $2.66{\pm}0.86$, wrist and hand area $2.59{\pm}0.86$, neck area $2.55{\pm}0.74$, and arm and elbow area $2.48{\pm}0.71$. By cares about musculoskeletal symptoms, taking medication or care represented 34.4%-46.7%, absence or leave 15.4%-28.7%, and job transfer 6.3%-11.5%. So experienced cases more than one thing among cares about musculoskeletal symptoms represented 39.6%-54%. In the diagnosis using moire topography, pain control necessity of cervicobrachial area was shown below; A(no symptoms) 20.7%, B1(need management/light symptoms) 64.6%, B2(need management/heavy symptoms) 11.5%, C1(need treatment/light symptoms) 3.0%, C2(need treatment/heavy symptoms) 0.2%. By lumbar area, A(no symptoms) 8.7%, B1(need management/light symptoms) 52.2%, B2(need management/heavy symptoms) 30.3%, C1(need treatment/light symptoms) 8.7%, C2(need treatment/heavy symptoms) was none. In the relation between pain control necessity and general characteristics, age(P=0.013), education(P=0.000), and job tenure(P=0.012) with pain control necessity showed differences with significance. The relation between pain control necessity and complaint of musculoskeletal symptoms of cervicobrachial and lumbar area showed no difference with significance; in cervicobrachial area represented P=0.708, lumbar area P=0.318 Conclusions: This study for musculoskeletal symptoms on workers at automobile manufacturing plant showed that complaint rates of musculoskeletal symptoms for cervicobrachial and lumbar area were so high, 63.9%. But Pearson's chi-square test analysis was utilized to study the relation between musculoskeletal symptoms and the diagnosis using moire topography, showed no differences with significance. They have no differences with significance, but the prevalence rates of diagnosis using moire topography for cervicobrachial and lumbar area were more higher than complaint rates of musculoskeletal symptoms; complaint rates of musculoskeletal symptoms were 52.4%, 34.5% and the diagnosis using moire topography were 79.3%, 91.3% for cervicobrachial and lumbar area. The results of this study indicate that the diagnosis using moire topography can find weak musculoskeletal disorders that an individual can not feel, not be judged work-related musculoskeletal disease. Therefore, this study has an important meaning that diagnosis using moire topography can predict and control own physical condition complete musculoskeletal disorders beforehand, since oriental medicine theory considers that prevention is important.

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