{"title":"在 Alinity i 分析仪上使用改进的 CMIA 与一家参考实验室的 LC-MS/MS 方法之间的他克莫司浓度具有良好的相关性，但与另一家参考实验室的 LC-MS/MS 方法之间却出现了意想不到的负偏差。","authors":"Kelsey Woodard, Tracey Kisler, Amitava Dasgupta","doi":"10.1093/ajcp/aqae005","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>We compared tacrolimus concentrations obtained by the more recently US Food and Drug Administration-approved tacrolimus assay (CMIA) on the Alinity i analyzer (Abbott Laboratories) with a liquid chromatography/tandem mass spectrometry (LC-MS/MS)-based method from 2 reference laboratories. We also investigated the correlation between the CMIA tacrolimus and Elecsys tacrolimus assays.</p><p><strong>Methods: </strong>Tacrolimus concentrations were measured in EDTA whole blood by the chemiluminescent microparticle immunoassay (CMIA) using the Alinity i analyzer, and then 2 aliquots were sent to 2 reference laboratories, both using ascomycin as the internal standard for the LC-MS/MS method.</p><p><strong>Results: </strong>The total precision of the CMIA tacrolimus assay was excellent. When tacrolimus concentrations obtained by the LC-MS/MS method from reference laboratory A were plotted on the x-axis and corresponding CMIA values were plotted on the y-axis, the following regression equation was observed: y = 0.9721x + 1.005 (r = 0.95), indicating no significant bias with the CMIA. However, when tacrolimus values obtained from reference laboratory B were used for comparison, the regression equation was y = 0.7664x + 1.775 (r = 0.93), indicating significant negative bias with the CMIA. When we compared tacrolimus concentrations obtained by reference laboratories A and B, we observed positive bias with tacrolimus concentrations obtained by reference laboratory B. However, tacrolimus concentrations obtained by both CMIA and Elecsys immunoassays were comparable.</p><p><strong>Conclusions: </strong>Because of good correlation of tacrolimus concentrations using the CMIA and LC-MS/MS from reference laboratory A, our long-term reference laboratory for drug analysis, we concluded that the CMIA on the Alinity i can be used for therapeutic drug monitoring of tacrolimus.</p>","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Good correlation between tacrolimus concentrations using improved CMIA on the Alinity i analyzer and LC-MS/MS method from a reference laboratory but unexpected negative bias with another LC-MS/MS method from a different reference laboratory.\",\"authors\":\"Kelsey Woodard, Tracey Kisler, Amitava Dasgupta\",\"doi\":\"10.1093/ajcp/aqae005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>We compared tacrolimus concentrations obtained by the more recently US Food and Drug Administration-approved tacrolimus assay (CMIA) on the Alinity i analyzer (Abbott Laboratories) with a liquid chromatography/tandem mass spectrometry (LC-MS/MS)-based method from 2 reference laboratories. We also investigated the correlation between the CMIA tacrolimus and Elecsys tacrolimus assays.</p><p><strong>Methods: </strong>Tacrolimus concentrations were measured in EDTA whole blood by the chemiluminescent microparticle immunoassay (CMIA) using the Alinity i analyzer, and then 2 aliquots were sent to 2 reference laboratories, both using ascomycin as the internal standard for the LC-MS/MS method.</p><p><strong>Results: </strong>The total precision of the CMIA tacrolimus assay was excellent. When tacrolimus concentrations obtained by the LC-MS/MS method from reference laboratory A were plotted on the x-axis and corresponding CMIA values were plotted on the y-axis, the following regression equation was observed: y = 0.9721x + 1.005 (r = 0.95), indicating no significant bias with the CMIA. However, when tacrolimus values obtained from reference laboratory B were used for comparison, the regression equation was y = 0.7664x + 1.775 (r = 0.93), indicating significant negative bias with the CMIA. When we compared tacrolimus concentrations obtained by reference laboratories A and B, we observed positive bias with tacrolimus concentrations obtained by reference laboratory B. However, tacrolimus concentrations obtained by both CMIA and Elecsys immunoassays were comparable.</p><p><strong>Conclusions: </strong>Because of good correlation of tacrolimus concentrations using the CMIA and LC-MS/MS from reference laboratory A, our long-term reference laboratory for drug analysis, we concluded that the CMIA on the Alinity i can be used for therapeutic drug monitoring of tacrolimus.</p>\",\"PeriodicalId\":2,\"journal\":{\"name\":\"ACS Applied Bio Materials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2024-07-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Bio Materials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ajcp/aqae005\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MATERIALS SCIENCE, BIOMATERIALS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Bio Materials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ajcp/aqae005","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MATERIALS SCIENCE, BIOMATERIALS","Score":null,"Total":0}
引用次数: 0
摘要
研究目的我们比较了 Alinity i 分析仪（雅培实验室）上最新获得美国食品和药物管理局批准的他克莫司测定法（CMIA）和 2 家参考实验室基于液相色谱/串联质谱（LC-MS/MS）的方法得出的他克莫司浓度。我们还研究了 CMIA 他克莫司检测法与 Elecsys 他克莫司检测法之间的相关性：方法：使用 Alinity i 分析仪通过化学发光微粒子免疫分析法（CMIA）测定 EDTA 全血中他克莫司的浓度，然后将 2 份等分样品送至 2 个参考实验室，这 2 个实验室均使用阿霉素作为 LC-MS/MS 方法的内标：结果：CMIA 他克莫司测定法的总精密度非常高。将参考实验室 A 用 LC-MS/MS 方法获得的他克莫司浓度绘制在 x 轴上，相应的 CMIA 值绘制在 y 轴上，可观察到以下回归方程：y = 0.9721x + 1.005（r = 0.95），表明 CMIA 无明显偏差。然而，当使用参考实验室 B 的他克莫司值进行比较时，回归方程为 y = 0.7664x + 1.775（r = 0.93），表明 CMIA 存在明显的负偏差。当我们比较参考实验室 A 和 B 所获得的他克莫司浓度时，我们发现参考实验室 B 所获得的他克莫司浓度存在正偏差，但 CMIA 和 Elecsys 免疫测定法所获得的他克莫司浓度相当：由于使用 CMIA 和参考实验室 A（我们的长期药物分析参考实验室）的 LC-MS/MS 测得的他克莫司浓度具有良好的相关性，我们认为 Alinity i 上的 CMIA 可用于他克莫司的治疗药物监测。
Good correlation between tacrolimus concentrations using improved CMIA on the Alinity i analyzer and LC-MS/MS method from a reference laboratory but unexpected negative bias with another LC-MS/MS method from a different reference laboratory.
Objectives: We compared tacrolimus concentrations obtained by the more recently US Food and Drug Administration-approved tacrolimus assay (CMIA) on the Alinity i analyzer (Abbott Laboratories) with a liquid chromatography/tandem mass spectrometry (LC-MS/MS)-based method from 2 reference laboratories. We also investigated the correlation between the CMIA tacrolimus and Elecsys tacrolimus assays.
Methods: Tacrolimus concentrations were measured in EDTA whole blood by the chemiluminescent microparticle immunoassay (CMIA) using the Alinity i analyzer, and then 2 aliquots were sent to 2 reference laboratories, both using ascomycin as the internal standard for the LC-MS/MS method.
Results: The total precision of the CMIA tacrolimus assay was excellent. When tacrolimus concentrations obtained by the LC-MS/MS method from reference laboratory A were plotted on the x-axis and corresponding CMIA values were plotted on the y-axis, the following regression equation was observed: y = 0.9721x + 1.005 (r = 0.95), indicating no significant bias with the CMIA. However, when tacrolimus values obtained from reference laboratory B were used for comparison, the regression equation was y = 0.7664x + 1.775 (r = 0.93), indicating significant negative bias with the CMIA. When we compared tacrolimus concentrations obtained by reference laboratories A and B, we observed positive bias with tacrolimus concentrations obtained by reference laboratory B. However, tacrolimus concentrations obtained by both CMIA and Elecsys immunoassays were comparable.
Conclusions: Because of good correlation of tacrolimus concentrations using the CMIA and LC-MS/MS from reference laboratory A, our long-term reference laboratory for drug analysis, we concluded that the CMIA on the Alinity i can be used for therapeutic drug monitoring of tacrolimus.
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