CAJ | 학술논문

目的：对 ALT，AST，GGT 和 LDH 检测方法由 JSCC 法变更为 IFCC 法进行性能验证。方法对新方法进行正确度、精密度验证，线性范围评价，临床可报告范围评价，并与原方法进行方法学比对试验。结果 ALT，AST，GGT 和LDH 正确度偏倚＜1／2允许总误差；批内精密度 CV＜1／4允许总误差，日间精密度 CV＜1／3允许总误差；线性范围评价所得的回归方程Y ＝aX ＋b，a 在0.97～1.03范围内，b 在可接受范围内；可报告范围验证结果显示，标本经不同比例稀释后，实测值／预期值均在90％～110％，说明在一定范围内的标本稀释检测结果可靠。与原方法进行的回归比对所得回归方程相关系数均接近于1。结论ALT，AST，GGT 和 LDH 检测的新方法分析性能满足临床检测需求。
목적：대 ALT，AST，GGT 화 LDH 검측방법유 JSCC 법변경위 IFCC 법진행성능험증。방법대신방법진행정학도、정밀도험증，선성범위평개，림상가보고범위평개，병여원방법진행방법학비대시험。결과 ALT，AST，GGT 화LDH 정학도편의＜1／2윤허총오차；비내정밀도 CV＜1／4윤허총오차，일간정밀도 CV＜1／3윤허총오차；선성범위평개소득적회귀방정Y ＝aX ＋b，a 재0.97～1.03범위내，b 재가접수범위내；가보고범위험증결과현시，표본경불동비례희석후，실측치／예기치균재90％～110％，설명재일정범위내적표본희석검측결과가고。여원방법진행적회귀비대소득회귀방정상관계수균접근우1。결론ALT，AST，GGT 화 LDH 검측적신방법분석성능만족림상검측수구。
Abstact:Objective To evaluate the method change from JSCC to IFCC for ALT,AST,GGT and LDH Detection.Methods The accuracy,precision,linearity and reportable range of the new detection method for ALT,AST,GGT and LDH,and the comparison analysis on the two different reagents were evaluated.Results All the accuracy bias of the testing items were within the required 1/2TEa,and all the within-run precision and between run precision were within the required 1/4TEa and 1/3TEa respectively.The linear verification results got the regression equation of the theoretical and measured valuesY =aX+b,in which a was within the range of 0.97~1.03,b was within an acceptable range.The reportable range verification re-sults showed that after the samples being diluted by different proportions,the measured/expected values were all between 90% and 110%,indicating that within a certain range of sample dilution the test esults were reliable.The comparison results showed the R 2 closed to 1.Conclusion The evaluation of the method change for ALT,AST,GGT and LDH detection met the basic requirements of the experiments in clinical diagnosis.