[논문]외부정도관리 프로그램을 이용한 비타민 D 검사의 6 시그마 분석

지명석

doi:10.15324/kjcls.2020.52.2.91

[국내논문] 외부정도관리 프로그램을 이용한 비타민 D 검사의 6 시그마 분석
Six Sigma Analysis of Vitamin D Measurement Using External Quality Assessment Program 원문보기

Korean journal of clinical laboratory science : KJCLS = 대한임상검사과학회지, v.52 no.2, 2020년, pp.91 - 97

지명석 (강북삼성병원 진단검사의학과)

초록
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비타민 D 검사의 표준화는 전 세계적으로 계속되고 있으며, 결과의 정확성을 향상시키기 위해 많은 노력을 기울였다. 본 연구의 목적은 외부 품질 평가(EQA) 프로그램을 이용하여 비타민 D 검사의 시그마 메트릭스 값을 분석하는 것이다. 시그마 메트릭스는 검사기관에서 수행한 정량적 시험에 사용되며, 분석결과는 품질 측면에서 객관적으로 시각화할 수 있다. 이 분석은 약 300개의 검사기관이 참여한 가운데, CAP의 외부정도관리 프로그램인 2019년 정확도 기반 비타민 D (ABVD) 조사 결과를 이용하여 수행하였다. CDC 표준검사기관에서 얻어진 표준 값 6개의 서로 다른 농도에서는 시그마 메트릭 값이 각각 1.00, 1.85, 2.42, 1.01, 1.54 및 0.78로 분석되었다. 평균 1.43 시그마 메트릭 값을 보여주었다. 특히, 검체 ABVD-16, 17의 결과값에서의 양성 편향은 비타민 D 측정을 위한 표준검사법인 액체크로마토그래피 탠덤 질량 분석(LC-MS/MS)에 대해서만 나타났다. 차이의 원인은 다양한 비타민 D 대사산물에 대한 다양한 교차 반응으로 설명된다. 검사 기관은 전반적인 성능을 개선해야 한다.

Abstract ▼ AI-Helper

Standardization of vitamin analysis continues around the world, and much effort has been made to improve the accuracy of the results. This study analyzed the sigma metrics of the vitamin D test using the external quality assessment (EQA) program. Sigma metrics is used for quantitative tests performed in the laboratory, and the test results can be objectively visualized in terms of quality. This analysis was performed based on the accuracy of the College of American Pathologists (CAP) using the results of the 2019 accuracy-based vitamin D (ABVD) survey, and about 300 laboratories participated in the survey. Reference values were obtained by the Center for Disease Control and Prevention (CDC) reference laboratory. At six different concentrations, the sigma metrics were analyzed to be 1.00, 1.85, 2.42, 1.01, 1.54 and 0.78, respectively. An average of 1.43 sigma metrics was determined. In particular, only positive biases for ABVD-16 and 17 were shown in the liquid chromatography tandem-mass spectrometry (LC-MS/MS), which is the standard method for vitamin D determination when compared to the reference values. The causes of the difference can be explained by cross reactivity to various vitamin D metabolites. Laboratories need to improve their overall performance.

Keyword

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문제 정의

Six Sigma analysis enables laboratories to measure current processes to give the laboratory some measure of performance and to obtain objective indicators for the desired quality improvement. The purpose of this study is to analyze six sigma metrics using external quality assessment of vitamin D.

제안 방법

Six sigma improves process quality by analyzing and eliminating error sources to reduce the variability of how they are currently used. A low sigma value (＜3 sigma) in the clinical laboratory identifies the test, indicating that action must be taken to improve the quality of the analysis and that the laboratory should use alternative methods. In a CAP survey, the performance of five test subgroups was evaluated in 307 laboratories.
Study has shown that the analyzer used for routine 25-OH D measurements in the laboratory is lower than the suggested minimum 3 sigma. The limitation of this study was that it was evaluated using only the mean and CV of the same group. The reason that Architect i System was able to give the best sigma metrics is because CV value, a factor when calculating sigma metrics, showed better result than other test methods.
The 25-OH D TEa requires a value within 25% of the CDC reference value or less than 5 ng/mL [18]. In this study, Many laboratories using LC-MS/MS have not reported values within acceptable limits, which are likely to be caused by calibration problems, variable sensitivity of measurement procedures at a low concentration (＜0.6 ng/mL) of 25-OH D2, and the detection of a C3-epimer at 25-OH D3.

대상 데이터

It used the ABVD proficiency test (PT) data from CAP in 2019. This PT was conducted twice a year and three fresh serum specimens were used for each test. 307 laboratories were participated in the 2019 ABVD PT survey, and major test instruments and methods were investigated.
The vitamin D was assay performed on four instruments. They were ADVIA Centaur, Centaur XP/XPT (Siemens, Munich, Germany), LC-MS/MS, Architect i System (Abbott Diagnostics, Lake Forest, IL, USA) and LIAISON (DiaSorin, Saluggia, Italy). TEa values for various parameters are obtained from CAP.

이론/모형

The reference target value for 25-OH D in each specimen was determined by the isotope-dilution LCMS/MS reference method procedure performed at the Fat-soluble Nutrients Laboratory, Nutritional Biomarkers Branch at the Centers for Disease Control and Prevention (Atlanta, Georgia). The external quality assessment (EQA) specimens were comprised of reference target value: 9.

성능/효과

The sigma metrics calculated for each instrument are shown Table 2. The best sigma metrics was that Architect i System averaged 2.80 sigma, followed by LC-MS/MS (2.09 sigma), Liaison (1.95 sigma), and ADVIA Centaur, Centaur XP/XPT (1.09 sigma).

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