심장성 Troponin T 현장검사의 수행능 평가
Performance Evaluation of the Point-of-Care Cardiac Troponin T Assay
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배경: 저자들은 Cobas h 232 POC system을 사용하여 Roche Cardiac POC Troponin T (Roche Diagnostics, Switzerland) 검사의 분석적 수행능을 평가하고자 하였다. 방법: Roche Cardiac POC Troponin T 정도관리물질을 사용하여 반복정밀도와 검사실내 비정밀도를 평가하였다. 또한 환자 검체를 사용하여 반복정밀도를 추가로 평가하였다. 다섯 가지 농도의 환자 검체를 사용하여 직선성을 평가하였다. 40명의 환자 검체를 사용하여 중앙검사실의 Elecsys Troponin T high sensitiveity 검사와 Roche Cardiac POC Troponin T 검사의 상관성을 평가하였다. 결과: 정도관리물질의 평균 농도는 441.6 ng/L로 반복정밀도는 8.5%, 검사실내 비정밀도는 8.6%였다. 환자 검체의 반복정밀도는 88.7 ng/L 농도에서 7.5%, 454.6 ng/L 농도에서 7.2%였다. 54.0 ng/L에서 1,347.7 ng/L까지의 구간에서 직선성을 확인하였다. 중앙검사실 검사와 현장검사의 상관성 평가에서 회귀방정식은 y=0.8933x +6.24였고 상관계수는 0.988이었다. 결론: Roche Cardiac POC Troponin T 검사는 현장검사가 필요한 경우 유용하게 사용될 수 있을 것으로 판단된다.
Abstract
Background: The point-of-care (POC) troponin T assay has been used in various clinical settings. Recently, a POC troponin T assay with an extended measurable range (40 ng/L–2,000 ng/L) was introduced. We aimed to evaluate the analytical performance of the Roche Cardiac POC Troponin T assay (POC TnT, Roche Diagnostics, Switzerland) using the cobas h 232 POC system. Methods: The repeatability and within-laboratory imprecision of the POC TnT assay were evaluated using the Roche Cardiac POC Troponin T level 2 control. Repeatability was also assessed using patient samples. Linearity of the POC TnT assay was evaluated using patient samples containing five different concentrations of troponin T. Performance of the Elecsys Troponin T high sensitivity assay (hs-TnT) was compared with that of the POC TnT assay using 40 patient samples. Results: The repeatability (%CV), and within-laboratory imprecision (%CV) using the level 2 control solution (mean troponin T, 441.6 ng/L) were 8.5% and 8.6%, respectively. The repeatability of patient samples containing 88.7 ng/L and 454.6 ng/L TnT was 7.5% and 7.2%, respectively. The POC TnT assay was confirmed to produce linear data between 54.0 ng/L and 1,347.7 ng/L. Relative to the hs-TnT assay, the Passing-Bablok linear regression equation (correlation coefficient) was y=0.8933x+6.24 (r=0.988). At a troponin T concentration of 40 ng/L, the estimated bias of the POC TnT assay was 1.972 ng/L (4.93%). Conclusions: Our data suggest that the Roche Cardiac POC Troponin T assay is reliable in cases where POC troponin T testing is required.
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