MassTrak Immunosuppressants Kit (IVD)
FDA 510(k)-cleared LC-MS/MS assay for tacrolimus quantification to support transplant patient care
Tacrolimus analysis using immunoassay-based technology can suffer from cross reactivity with drug metabolites, resulting in overestimation of the parent drug. Waters MassTrak Immunosuppressants Kit (IVD), when used with Waters ACQUITY UPLC I-Class PLUS and Xevo TQD IVD Systems, delivers greater specificity for measuring tacrolimus concentrations in kidney and liver transplant patients. This leads to improved accuracy compared to immunoassays and supports individualized dosing to help manage the risks of rejection and toxicity.
This comprehensive IVD kit includes all of the chemical reagents, the analytical column, and a validated method provided in the Directions for Use. No method development or validation is required when used with the Waters recommended LC-MS/MS system. The device is indicated for the quantification of the immunosuppressive drug tacrolimus (FK506; Prograf®, Astellas Europe, Munich, Germany) in whole blood samples from liver and kidney transplant patients as an aid in the management of tacrolimus therapy.
The MassTrak Immunosuppressants Kit (IVD) is 510(k)-cleared and listed with the FDA as a Class 2 device. MassTrak Immunosuppressants Kits (IVD) are available for sale and shipment exclusively in the United States.
MassTrak Immunosuppressants Kit (IVD)
Overview
- Adopt the first and only FDA 510(k)-cleared commercial LC-MS/MS solution for tacrolimus monitoring—now available on Waters Xevo TQD IVD System
- Run assays with confidence using a complete kit that includes all required chemical reagents— calibrators and controls, internal standard and tuning solution, analytical column, and validated method (outlined in the Directions for Use)
- Eliminate the need for method development or validation when using the validated kit method with the ACQUITY UPLC I-Class PLUS/Xevo TQD IVD System
- Achieve greater specificity with this LC-MS/MS kit that is specific for the parent drug tacrolimus and doesn’t suffer from cross-reactivity with drug metabolites
- Attain sensitivity as low as 0.5 ng/mL and harmonize tacrolimus results across labs. In-house testing showed an average method bias of less than 6% from method mean for 41 EQA samples tested
- Realize lower reagent costs when compared to immunoassay with a MassTrak kit cost of $5.51 per sample and expect to save at least $200k in reagent costs per year2 upon switching from immunoassay to the MassTrak Immunosuppressants LC-MS/MS solution
1 Assumes 10% discount off list price
2 Assumes lab runs 35k tacrolimus patient samples per year and pays an immunoassay reagent cost of $12 per sample
MassTrak Immunosuppressants Kit (IVD) Characteristics
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Calibrator set containing lyophilized tacrolimus in whole blood -
Format: 6 x 3 mL (reconstitution volume)
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Shelf life: 53 months at ≤ -20 °C
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In-use stability: 1 month at ≤ -20 °C; 1 week at 2–8 °C
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QC Set containing lyophilized tacrolimus in whole blood
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Format: 3 x 3 mL (reconstitution volume)
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Shelf life: 53 months at ≤ -20 °C
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In-use stability: 1 month at ≤ -20 °C; 1 week at 2–8 °C
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Internal standard solution containing lyophilized ascomycin
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Format: 1 x 250 mL (reconstitution volume)
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Shelf life: 53 months at ≤ -20 °C
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In-use stability: 3 weeks at 2–8 °C
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Tuning mixture containing lyophilized tacrolimus and ascomycin
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Format: 1 x 5 mL (reconstitution volume)
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Shelf life: 53 months at ≤ -20 °C
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In-use stability: 1 week at 2–8 °C
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Robust C18 column for performing online solid-phase extraction (SPE)
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Validated for 500 injections
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P/N: 186002695
Ensure accurate tacrolimus results
41 EQA samples (IPT scheme, UK) covering a concentration interval of 1.4 to 21.7 ng/mL were tested using the MassTrak Immunosuppressants Kit on the ACQUITY UPLC I-Class PLUS/Xevo TQD IVD System. All EQA sample results were within ±3sd of IPT scheme method mean. The average bias from the method mean for all samples was –5.8%.
Typical concentration values are shown in the table images. Please refer to your lot-specific certificate of analysis (COA) for exact concentrations. The certification of analysis (COA) can be found in the box or at www.waters.com.
Achieve a high level of precision for your tacrolimus assay
Data from three separate studies, using three different patient pools (low, medium, high) indicated a total imprecision of <8% between 2.04 ng/mL and 29.9 ng/mL.
Improve your laboratory’s efficiency
The MassTrak Immunosuppressants Kit offers a wide reportable range for tacrolimus between 0.68 ng/mL and 31.7 ng/mL for tacrolimus, negating the need to dilute samples. This means fewer retests and more predictable costs.
Resources
Documents
- Evaluation of the Waters MassTrak LC-MS/MS Assay for Tacrolimus and a Comparison to the Abbott Architect Immunoassay
- Standardization of LC-MS for Therapeutic Drug Monitoring of Tacrolimus
- A Rapid, Simple And Sensitive Liquid Chromatography-Tandem Mass Spectrometry Method For Routine Clinical Monitoring Of Tacrolimus With The Waters Masstrak™ Immmunosuppressant Kit
- Multi-Center Evaluation Of A Commercial Kit For Tacrolimus Determination By LC/MS/MS
- The MassTrak (TM) reagent kit for tacrolimus quantification by HPLC-MS/MS: Comparison for accuracy with three commercial immunoassay procedures
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