אילמ"ר - האיגוד הישראלי למדעי המעבדה הרפואית

אילמ"ר - האיגוד הישראלי למדעי המעבדה הרפואית

כינוס שנתי ה-48 | 2014

פוסטרים להצגה בכינוס

COMPARISON OF EVEROLIMUS QMS IMMUNOASSAY ON ARCHITECT CI4100 AND LC-MS/MS: LACK OF AGREEMENT IN ORGAN TRANSPLANTED PATIENTS

Inna Scherb1,2, Marina Krasik1,2, Gil Ring1,2, Erica Hoffer2, Daniel Kurnik3, Yedidia Bentur2, Edna Efrati1,2

1. Laboratory of Toxicology, Pharmacology and Pharmacogenetics, 2. Israel Poison Information Center, 3. Clinical Pharmacology Unit, Rambam Medical Center, The Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel

 

Background: Liquid chromatography with mass spectrometry (LC-MS/MS) is the method of choice for the determination of everolimus whole blood concentrations, but is not routinely available. Therefore, immunoassays have been developed for clinical monitoring of everolimus. In previous studies, the QMS immunoassay had a positive bias compared to LC-MS/MS, but was judged acceptable, although clinical agreement (e.g. 95% limits of agreement) was not reported. The objective of this study was to assess whether the agreement between the QMS assay and the reference LC-MS/MS method was clinically acceptable for using them interchangeably in therapeutic everolimus monitoring.

Methods: Whole blood samples from organ transplanted patients on everolimus therapy were analyzed by both QMS (on Architect ci4100 analyzer) and LC-MS/MS. Paired results were compared using paired Student's t-test, Bland-Altman plots, and Deming regression analysis. The proportion of falsely supra- and subtherapeutic results on the QMS assay compared to the reference LC-MS/MS were calculated.


Results: Among 250 samples (169 patients), mean everolimus concentrations determined by LC-MS/MS and QMS assays were 4.8±2.1 and 6.3±2.1 ng/mL, respectively (p<0.001), with 95% lines of agreement between -2.1 to 5.2 ng/mL, a range corresponding to 152% of the mean concentration. When stratified by type of transplant, a similar positive bias was found in each subgroup (all p < 0.014). 69% of the samples yielding supratherapeutic concentrations on the QMS assay were within the therapeutic range on the LC-MS/MS.


Conclusion: The everolimus QMS immunoassay, using the Architect ci4100 analyzer, had a significant positive bias compared to LC-MS/MS, with a wide range between the limits of agreement. The lack of agreement may result in inadequate everolimus dose adjustments, suggesting that the QMS assay cannot be used interchangeably with the LC-MS/MS method for therapeutic everolimus monitoring in organ transplanted patients.

 

 

לתקצירי הכנס     חזרה לריכוז הפוסטרים 2014


דף הבית | מי אנחנו | רישום לאילמ"ר ולאתר | תקנון | חברי הועד | מערכת האתר | צור קשר | מקצוע המעבדנות הרפואית | מישיבות ועד אילמ"ר | המועצה למעבדות במשה"ב |
חיפוש פרטי חבר | עדכון פרטים | ועדות מקצועיות | מפגשים וועדות המטולוגיה וקרישה | פורום אנדוקריני | פורום האיכות | כנסים שנתיים | ימי עיון | קפה מדע | כנסים של אגודות אחרות | פעילות בינלאומית | אבטחת איכות סקירת ספרות | מכשור ושיטות | דיווחי המעבדות | פרסים | לזכר חברנו | קישורים | דרושים | מידע מקצועי מחברות תומכות    
מומלץ לצפייה ברזולוציה של 768X1024