PDF(Pubmed)
Abstract：
UNASSIGNED: Calprotectin (CP) is a calcium and zinc binding protein that is widely measured on faecal samples but its determination in other biological fluids might be of interest. The aim of this work was to validate the measurement of CP in pleural fluid by chemiluminescence.
UNASSIGNED: LIAISON®XL, a fully automated chemiluminescence analyzer, was used for CP quantification on pleural fluid. A validation protocol was designed using both quality control materials provided by the manufacturer and pools of pleural fluid samples. Stability, imprecision, bias, linearity, detection capability and carry over effect were evaluated.
UNASSIGNED: CP was stable on pleural fluid at least one week, under refrigerated conditions, and four weeks at -80 °C. The observed intra- and inter-day imprecision was between 2.2 and 6.49 %, with a negative bias under 5.51 %. The linearity of the method was verified up to 2,000 ng/mL. The LoQ for the assay was 48.52 ng/mL. A statistically significant carry-over effect was observed after measuring CP concentrations above the upper limit of linearity, but given the observed magnitude, a clinically relevant impact should not be expected.
UNASSIGNED: DiaSorin Liaison® calprotectin assay allows reliable measurement of CP in pleural fluid.
UNASSIGNED: LIAISON®XL, a fully automated chemiluminescence analyzer, was used for CP quantification on pleural fluid. A validation protocol was designed using both quality control materials provided by the manufacturer and pools of pleural fluid samples. Stability, imprecision, bias, linearity, detection capability and carry over effect were evaluated.
UNASSIGNED: CP was stable on pleural fluid at least one week, under refrigerated conditions, and four weeks at -80 °C. The observed intra- and inter-day imprecision was between 2.2 and 6.49 %, with a negative bias under 5.51 %. The linearity of the method was verified up to 2,000 ng/mL. The LoQ for the assay was 48.52 ng/mL. A statistically significant carry-over effect was observed after measuring CP concentrations above the upper limit of linearity, but given the observed magnitude, a clinically relevant impact should not be expected.
UNASSIGNED: DiaSorin Liaison® calprotectin assay allows reliable measurement of CP in pleural fluid.
摘要：
■钙卫蛋白（CP）是一种钙和锌结合蛋白，可在粪便样品中广泛测量，但在其他生物流体中的测定可能会引起人们的兴趣。这项工作的目的是通过化学发光验证胸膜液中CP的测量。
■LIAISON®XL，全自动化学发光分析仪,用于胸膜积液的CP定量。使用制造商提供的质量控制材料和胸膜液样本库设计验证方案。稳定性,不精确,偏见，线性度对检测能力和结转效果进行了评价。
■CP在胸膜液中至少一周稳定，在冷藏条件下，在-80℃下4周观察到的日内和日间不精确度在2.2％和6.49％之间，负偏差在5.51%以下。该方法的线性被验证为高达2,000ng/mL。测定的LoQ为48.52ng/mL。在测量高于线性上限的CP浓度后，观察到具有统计学意义的结转效应，但是考虑到观测到的震级，临床相关影响不应预期.
■DiaSorinLiaison®钙卫蛋白测定法可以可靠地测量胸膜液中的CP。
■LIAISON®XL，全自动化学发光分析仪,用于胸膜积液的CP定量。使用制造商提供的质量控制材料和胸膜液样本库设计验证方案。稳定性,不精确,偏见，线性度对检测能力和结转效果进行了评价。
■CP在胸膜液中至少一周稳定，在冷藏条件下，在-80℃下4周观察到的日内和日间不精确度在2.2％和6.49％之间，负偏差在5.51%以下。该方法的线性被验证为高达2,000ng/mL。测定的LoQ为48.52ng/mL。在测量高于线性上限的CP浓度后，观察到具有统计学意义的结转效应，但是考虑到观测到的震级，临床相关影响不应预期.
■DiaSorinLiaison®钙卫蛋白测定法可以可靠地测量胸膜液中的CP。
