How do YOU measure a patient’s second chance?

[ MassTrak Immunosuppressants Kit ]

Clinical laboratories throughout the world have adopted LC/MS/MS for routine immunosuppressant drug monitoring. Since 2001, Waters has pioneered TDM solutions for LC/MS/MS. The MassTrak Immunosuppressants Kit is the first com-mercially availible kit designed specifically for use with LC/MS/MS and cleared by the FDA for monitoring Tacrolimus levels in kidney and liver transplant patients.

■ The MassTrak Immunosuppressants Solution enables the accurate, precise and specific quantification of Tacrolimus on a Waters ACQUITY UPLC® coupled to an ACQUITY TQD (LC/MS/MS system). 510 (k) cleared and CE marked for in vitro diagnostic use.

■ Intended for the quantification of the immunosuppressive drug Tacrolimus (FK506; Prograf®) in liver and kidney transplant patient whole blood samples as an aid in the management of Tacrolimus therapy.

■ The MassTrak Immunosuppressants Solution is specific for the parent drug Tacrolimus and overcomes the inherent weaknesses of immunoassays due to mass selection. Immunoassays are nonspecific and can cross-react with drug metabolites which may lead to the overestimation of the parent drug.

■ MassTrak LC/MS/MS methods for immunosuppressant drug monitoring offer increased sensitivity, consistently measuring target compounds at low ng/mL levels (0.5 ng/mL).

■ Cost effective compared to immunoassay. Lower consumable and operating costs than immunoassay methods.

[ MASSTRAK IMMUNOSUPPRESSANTS PRODUCT SPECIFICATIONS ]

MassTrak Immunosuppressants Solution for Monitoring Tacrolimus

LC/MS/MS System Technology for Clinical Drug Monitoring – Providing Confidence in Patient Results

Cleared for in vitro diagnostic use in the United States. CE marked in accordance with the in vitro diagnostic (IVD) Directive 98/79/EC. Only available for sale in the United States, Canada, the European Economic Area (EEA) and Switzerland. Please contact Waters to check availability in other countries.

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Assay Name MassTrak Immunosuppressants Kit

Method UPLC-MS/MS

Run Rate ~ 30 samples/hr

Reportable Range 0.5-30 ng/mL

Calibrators *6 points: 0, 3, 6, 12, 20, 30 ng/mL (nominal values)

Controls *3 levels: 2, 8, 22 ng/mL (nominal values)

Internal Standards Ascomycin

Sample Type & Volume Whole blood (preserved in EDTA), 50 µL

Sample Preparation Manual pretreatment

Column Chemistry MassTrak TDM 2.1 mm x 10 mm C18

* Actual concentrations are lot specific

UNPARALLELED SPECIFICITYLC/MS/MS assays are specific for the parent compound. The MassTrak Immunosuppressants assay provides Tacrolimus concentrations independent of the level of known metabolites in patient samples.

Mass spectrum for Tacrolimus highlighting specificity for the parent compound without cross reactivity from drug metabolites.

RELIABLE PRECISIONKeeping within the therapeutic range is crucial to successful patient outcomes. Precise measurement of Tacrolimus ensures confidence in quality results. The MassTrak Immunosuppressants Kit exhibits a total imprecision of ≤10 % total CV, resulting in quality results and agreement across samples.

Three different pools of patient whole blood (low, medium, and high) were analyzed in duplicate, and two assays were performed each day for 20 days.

Correlation study comparing the MassTrak Immunosuppressants Kit test results to the international immunosuppressive drug measurement proficiency testing scheme (Analytical Services International Ltd.) target values for Tacrolimus.

EXCELLENT CORRELATIONHarmonization of intra and inter-laboratory results benefits the quality of care for the

ultimate end users, transplant recipients.y = 0.9946x + 0.0621R2 = 0.99427

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35

0 5 10 15 20 25 30 35

EQA Target Value Tacrolimus (ng/mL)

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mL)

TACROLIMUS

Sample

WITHIN RUN BETWEEN RUN TOTAL

Mean (ng/mL) N SD %CV SD %CV SD %CV

Low 2.04 80 0.11 5.6 0.04 2.1 0.16 7.6

High 10.91 80 0.35 3.2 0.04 0.4 0.4 3.7

29.90 80 0.72 2.4 0.51 1.7 1.12 3.7

0780 785 790 795 800 805 810 815 820 825 830 835 850 m/z

100

%

840 845

Didemethyl Tacrolimus

Demethyl Tacrolimus Hydroxy Tacrolimus

TacrolimusAscomycin

Waters, The Science of What’s Possible, ACQUITY UPLC, UltraPerformance LC and UPLC are registered trademarks of Waters Corporation. MassTrak is a trademark of Waters Corporation. All other trademarks are the property of their respective owners.

©2011 Waters Corporation. Produced in the U.S.A. May 2016 720004041EN KP-VW-PDF

ORDERING INFORMATIONDescription Part No.

MassTrak Immunosuppressants Kit 176000898

2.1 x 10 mm Holder Kit for TDM Column WAT097958

Inquire about reagent rental options.

LABORATORY TOOLS THAT MAKE THE MOST OF A TRANSPLANT PATIENT’S SECOND CHANCE

The MassTrak Immunosuppressants Kit, used with Waters LC/MS/MS technology, provides greater specificity for measuring tacrolimus concentrations in transplant patients compared against older, immunoassay-based testing. It’s the solution you need for individualizing dosing and minimizing the risks of rejection and toxicity.

ACQUITY UPLC® coupled to an ACQUITY TQD (LC/MS/MS System for immunosuppressant drug monitoring).