B-322 Assessment of MassTrak™ Immunosuppressant Calibrator and Control Sets: Confidence in Your Calibrators

Abstract

Abstract Background The analytical performance of the Waters MassTrak Immunosuppressant Calibrator and Quality Control Sets (IVD) were evaluated using a laboratory developed LC-MS/MS method, to analyze all four immunosuppressants in a single run. Methods The MassTrak Immunosuppressant Calibrator and Quality Control Sets were used to quantify cyclosporine, everolimus, sirolimus and tacrolimus in human whole blood. Samples (50 µL) were treated with zinc sulfate and acetonitrile containing internal standards. A water/methanol/ammonium acetate gradient was used with a Waters C18 HSS SB Column on a Waters ACQUITYTM UPLTM I-Class FL and Xevo TQ-S micro Mass Spectrometer with an injection-to-injection time of less than 2 min. Results No system carryover was observed from high concentration samples. Precise quantification (≤20% CV, ≤15% bias) at concentrations equal to or lower than the lowest concentration calibrator was demonstrated. Total precision and repeatability (3 pools, 5 replicates, 5 days; n = 25) were determined to be ≤7.1% CV. The method was linear over the measuring interval of 19.3–1500 ng/mL (cyclosporine) and 0.77–39 ng/mL (everolimus, sirolimus and tacrolimus). Addition of high concentrations of several endogenous materials did not affect quantification. External quality assurance samples for all drugs met the scheme acceptance criteria (cyclosporine: n = 39, range 0–2658 ng/mL, mean % bias +1.0%; everolimus: n = 35, range 0–21.9 ng/mL, mean % bias +0.9%; sirolimus: n = 34, range 0–74.2 ng/mL, mean % bias −7.5%; tacrolimus: n = 40, range 0–23.0 ng/mL, mean % bias −0.5%). Conclusion Performance of the Waters MassTrak Immunosuppressant Calibrator and Quality Control Sets, with the developed method described provide good method performance. The accuracy data demonstrates confidence in the MassTrak Immunosuppressant Calibrator Set, providing harmonization across laboratories. This method is an example of an application using the instrumentation, software and consumables described in this document. This method has not been cleared by any regulatory entity for diagnostic purposes. The end user is responsible for completion of the method development and validation. MassTrak Immunosuppressant Calibrator and Quality Control Sets are not available for sale in all countries.