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INTERNAL QUALITY CONTROL APPLIED TO CENMAST, A PRODUCT TO DETECT MASTITIS

机译:内部质量控制应用于CENMAST,这是一种检测乳腺炎的产品

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CENMAST is a diagnostic test similar to the California Mastitis Test (CMT). During the production process at Centro Nacional de Sanidad Agropecuaria (CENSA), the Quality control Laboratory tests the specifications of the product, determining the active substance, pH and density, the results are under Internal Quality Control Program. A batch was evaluated as a working reference material, to be used as a sample of quality control, also it was used for the validation of the assay precision under repeatability conditions and intermediate conditions changing the analysts, working days, equipments and calibration. A suitable precision among replicas was obtained and critical ranges of 0,03, 0,30, 0,006 were reported for the active substance, pH and density respectively. The distribution of the control sample values plotted on the control graphics demonstrated that the analytical methods are under statistic control. The quality internal control demonstrated the reliability of the results in control and product samples when evaluated in parallel.
机译:CENMAST是类似于加州乳腺炎测试(CMT)的诊断测试。在圣地亚哥国家农业食品中心(CENSA)的生产过程中,质量控制实验室测试产品的规格,确定活性物质,pH和密度,结果在内部质量控制计划的控制下。将一批作为工作参考材料进行评估,用作质量控制样品,还用于在重复性条件和中间条件(改变分析人员,工作日,设备和校准)的情况下验证测定精度。在复制品之间获得了合适的精度,并且据报道活性物质,pH和密度的临界范围分别为0.03、0.30、0.006。在控制图形上绘制的控制样品值的分布表明,分析方法处于统计控制之下。并行评估时,质量内部控制证明了对照和产品样品中结果的可靠性。

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