자동화학분석기 Atellica CH 930 Analyzer의 성능 평가
Evaluation of the Analytical Performance of Atellica CH 930 Automated Chemistry Analyzer
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배경: 최근 새로운 자동화학분석기 Atellica CH 930 Analyzer (Siemens Healthcare Diagnostics, Germany)가 소개되었다. 이 장비는 미리 정해진 계획에 따라 자동으로 내부 정도관리물질을 측정하는 기능이 있다. 이를 위해 장비 내에 정도관리 물질을 저장하는 장치가 있다. 저자들은 새로운 Atellica System의 일반 화학 검사에 대한 분석 성능을 평가하고자 하였다. 방법: 정밀도 평가는 일반 화학 검사 29개 항목에 대해 3가지 농도의 정도관리물질로 두 가지 저장방법으로 시행하였다. 정밀도 평가 기간 동안 정도관리물질을 장비의 전용 저장장치에 저장하여 정밀도 평가를 시행하였다. 추가로, 외부 냉장고에 정도관리물질을 저장하고, 검사 시기마다 장비에 장착하면서 재현성 평가를 시행하였다. 또한, 직선성, 교차오염률, 현재 방법과의 일치도 평가를 시행하였다. 결과: 검사실 내 변이계수는 tCO2를 제외한 모든 항목에서 5.0% 이내였고, 정도관리물질 보관방법에 따른 차이는 없었다. 장비 내 전용 저장공간에 정도관리물질을 저장한 경우 tCO2의 변이계수는 세 가지 농도에서 각각 5.2%, 5.8% 및 5.1%였다. 직선성 평가 결과 비직선성이 5% 미만으로 우수하였다. 비록 대다수 항목에서 좋은 일치도를 보였으나, Ca, T. bilirubin, AST, Cl 등 항목에서 동등하지 않은 결과를 보였다. 결론: Atellica CH 930 Analyzer는 일반 화학 검사 항목에서 우수한 정밀도, 직선성, 일치도를 보여주었다. 장비에 탑재된 저장장치를 이용한 자동 정도관리 기능은 안정성이나 정밀도에서 문제가 없었다. 이를 통해 수작업에 사용되는 시간을 줄이고 검사자가 정도관리 결과 검토에 더욱 집중할 수 있게 하여, 정확하고 신뢰성 있는 결과를 보고를 하는 데 도움이 될 것이다.
Abstract
Background: Recently, a new automated chemistry analyzer, Atellica CH930 (Siemens, Germany), was introduced. It automatically measures internal quality control (QC) materials according to a pre-determined schedule. For this purpose, the instrument has space for storage of QC materials. We evaluated the analytical performance of chemistry items by using the Atellica system. Methods: The precision of 29 items was evaluated with three levels of QC materials with two storage methods. We stored the QC materials in the dedicated storage space in the instrument during the precision evaluation period. In addition, we aliquoted and stored the materials in the refrigerator, and then loaded the material in a timely manner. Linearity, carry-over, and agreement with current methods were also evaluated. Results: The within-laboratory coefficient of variation (CV) of most items, except for total CO2 (tCO2), was within 5.0% in both QC storage methods without significant differences in CV between storage methods. The CV of tCO2 was 5.2%, 5.8%, and 5.1% at three different levels when the QC materials were stored in a dedicated space in the instrument. The linearity was acceptable, showing <5% nonlinearity. Although good agreement was observed for most items, some items, such as calcium, total bilirubin, aspartate transaminase, and chloride, showed unequivalent results. Conclusions: Atellica CH930 showed acceptable precision, linearity, and agreement in routine chemistry items. The automatic QC function using the storage device has no problem with stability or precision. It can reduce the manual process, allowing technicians to focus on reviewing the QC results and reporting reliable results.
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