Analytical Methodology: Development And Interpretive App

分析方法：开发和解释应用程序

• 批准号: 7004402
• 负责人: NADJA REHAK
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7004402
• 关键词: analytical chemistry; analytical method; anticoagulants; blood chemistry; blood tests; centrifugation; chemical stability; chemical structure function; enzyme induction /repression; heparin; lithium; physical separation; plasma; sample collection; serum; technology /technique development; temperature; tissue /organ preservation

Autoverification of results generated by the automated analyzers is used by the clinical laboratories to increase efficiency, streamline the work flow and decrease turnaround time. However, this requires that the integrity of specimens is assured ?hemolyzed, lipemic and icteric specimens must be identified and rejection rules set to avoid verification of erroneous results. In our laboratory we measure the common chemistry analytes with Synchron LX20 Clinical System that offers index panel for identification of hemolyzed (H), lipemic (L) and icteric (I) specimens. We established the rejection rules by measuring H, I, and L for serum samples with known concentration of total hemoglobin (THgb =0-500 mg/dL, n=20), total bilirubin (TBil=1.9-28.4 mg/dL, n=36) and triglycerides (Trig=46-7370 mg/dL, n=29), and determined the effect of H, I and L values on 29 common serum chemistry analytes. None of the studied serum analytes were affected when I<= 28 and the rejection limit was set to be >28. Following analytes were affected at increased L values: HDLC, LDLC (L>2), DBil, TBil (L>4), Alb, CO2 (L>5), and at increased H values: LD and Fe (H>1), K (H>2), AST, CK, DBil, TBil (>3), AMYL (H>4), ALT (>6), Na (>8) and, therefore, these L and H values were set as the rejection limits. For the remaining analytes the rejection limits were set as L>8 and H>9. Whenever the I or H limit was exceeded the test was reported as icteric or hemolyzed, while specimen with rejected L limit, except for LDLC, were ultracentrifuged and reanalyzed. Implementation of these rejection limits on the number of affected specimen / tests in the calendar year 2003 is summarized as follows: 986 specimens (0.89% of total) were received hemolyzed (H=2, n=318; H=3, n=310, H=4, n=448, H=5, n=292, H=6, n=132, H=7, n=112; H=8, n=122; H=9, n=145; H=10, n=894) resulting in 2773 tests reported as ?hemolyzed?; 244 specimens (0.22% of total) needed to be ultracentrifuged. There were no specimens with I>28. Cost analysis: In our laboratory the serum index panel is performed automatically with each of the 29 LX20 methods. For these tests, on average, the cost per test increased by $0.013 that translates to an increase in the cost per year by 5.49%.

临床实验室使用自动分析仪产生的结果自动化，以提高效率，简化工作流程并减少周转时间。但是，这要求确保标本的完整性？必须识别溶血，脂肪和晶状体标本，并设置拒绝规则，以避免验证错误的结果。在我们的实验室中，我们测量了使用同步LX20临床系统的常见化学分析物，该系统提供了用于鉴定溶血（H），脂肪（L）和颅（I）标本的索引面板。我们通过测量已知浓度的总血红蛋白浓度（THGB = 0-500 mg/dl，n = 20），总胆红素（tbil = 1.9-28.4 mg/dl，n = 36）和甘油酸酯（Trig = 46-7370MG/n = 29）和n = 29，我们确定了拒绝规则。 29个常见血清化学分析物的值。当i <= 28时，研究的血清分析物没有影响，拒绝限制为> 28。 Following analytes were affected at increased L values: HDLC, LDLC (L>2), DBil, TBil (L>4), Alb, CO2 (L>5), and at increased H values: LD and Fe (H>1), K (H>2), AST, CK, DBil, TBil (>3), AMYL (H>4), ALT (>6), Na (>8) and, therefore, these L and H将值设置为拒绝限制。对于其余的分析物，将拒绝限设置为l> 8和h> 9。每当超过I或H限制的限制时，测试被报告为乳脂或溶血，而拒绝L限制的样品除非LDLC除外，都将被超级离心并重新分析。对这些拒绝的实施限制了2003年日历年中影响样本 /测试数量的数量如下：收到986个样本（占总数的0.89％）（H = 2，n = 318; H = 3，n = 3，n = 310，n = 310，h = 4，h = 4，h = 4，n = 448，n = 448，n = 448，h = 5，n = 5，n = 292，n = 7，n = 6，n = 7，n = 7，n = 8，n = 8，n = 8，n = 8，n = 8，n = 32; n = 122; h = 9，n = 145; h = 10，n = 894），据报道？需要进行244个标本（占总数的0.22％）。 I> 28没有标本。 成本分析：在我们的实验室中，使用29 LX20方法中的每一种都会自动执行血清指数面板。对于这些测试，平均而言，每次测试成本增加了0.013美元，这将每年的成本增加5.49％。