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首页> 外文期刊>Indian journal of clinical biochemistry: IJCB >Validation Protocol: First Step of a Lean-Total Quality Management Principle in a New Laboratory Set-up in a Tertiary Care Hospital in India
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Validation Protocol: First Step of a Lean-Total Quality Management Principle in a New Laboratory Set-up in a Tertiary Care Hospital in India

机译：验证协议：印度三级医院新实验室建立精益全面质量管理原则的第一步

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摘要

Method validation is pursued as the first step in establishing Lean-Total Quality Management in a new clinical laboratory, in order to eliminate error in test results. Validation of all the new tests were done (with particular reference to alkaline phosphatase) by verifying reference intervals, analytical accuracy and precision, inter-assay and intra-assay variations, analytical sensitivity, limit of detection, linearity and reportable range, i.e. (i) Analytical measurement range (AMR) and (ii) Clinically reportable range (CRR). Our obtained reference range was within that of the manufacturer's and showed high degree of analytical accuracy between two laboratories (r~2 = 0.99). Precision was comparable with the manufacturer's claim with inter-assay variation CV 1.04% and intra-assay variation CV 1.54%. Lowest limit of detection was 1.0324 +- 0.007 with CV 0.34%. AMR was also verified with CV 1.26 and 0.69%, for level 1 and level 2 control sera, respectively. The assay was linear with different dilutions. Lean concept was also verified with high recovery percentage. Validation ensures that accurate and precise results are reported in a clinically relevant turn around time.
机译：方法验证是在新的临床实验室中建立精益全面质量管理的第一步，以消除测试结果中的错误。通过验证参考区间，分析准确度和精密度，批间和批内差异，分析灵敏度，检测极限，线性和可报告范围，对所有新测试进行验证（特别是针对碱性磷酸酶）。 ）分析测量范围（AMR）和（ii）临床报告范围（CRR）。我们获得的参考范围在制造商的参考范围内，并且在两个实验室之间显示出很高的分析准确性（r〜2 = 0.99）。精密度与制造商的要求相称，批间差异CV为1.04％，批内差异CV为1.54％。最低检测限为1.0324±0.007，CV为0.34％。 1级和2级对照血清的AMR也分别以CV 1.26和0.69％进行了验证。该测定是线性的，具有不同的稀释度。精益概念也得到了验证，回收率很高。验证可确保在临床相关的时间内报告准确和准确的结果。

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