Immunoassay-based analysis of tacrolimus can be affected by cross-reactivity with drug metabolites, leading to overestimation of the parent drug.
The Waters MassTrak Immunosuppressants Kit (IVD™), when used with the Waters ACQUITY™ UPLC™ I-Class PLUS and Xevo™ TQD IVD™ Systems, provides enhanced specificity for measuring tacrolimus levels in patients who have undergone kidney and liver transplants. This improves accuracy compared with traditional immunoassays and supports personalised dosing, helping reduce the risks of rejection and toxicity.
This all-encompassing IVD kit comprises all necessary chemical reagents, an analytical column, and a validated method as outlined in the Directions for Use. There is no requirement for method development or validation when used with the Waters-recommended LC-MS/MS system.
The device is intended for the quantification of the immunosuppressive drug tacrolimus (FK506; Prograf®, Astellas Europe, Munich, Germany) in whole-blood samples from liver and kidney transplant patients, serving as a support tool for the management of tacrolimus therapy.
The MassTrak Immunosuppressants Kit (IVD) has received 510(k) clearance and is registered with the FDA as a Class 2 device. MassTrak Immunosuppressants Kits (IVD) are available for purchase and distribution solely within the United States.
Waters MassTrak Immunosuppressants Kit (IVD) | For LC-MS/MS analysis of Tacrolimus levels in patient whole blood samples to aid with Therapeutic Drug Monitoring of Tacrolimus. Image Credit: Waters Advanced Diagnostics
Overview
- Experience reduced reagent expenses compared to immunoassay, with a MassTrak kit costing $5.51 per sample, and anticipate savings of at least $200k in reagent costs annually upon transitioning from immunoassay to the MassTrak Immunosuppressants
- Conduct assays with assurance using a comprehensive kit that encompasses all necessary chemical reagents – calibrators and controls, internal standard and tuning solution, analytical column, and a validated method
- Use the first and only FDA 510(k)-cleared commercial LC-MS/MS solution for monitoring tacrolimus – now accessible on the Waters Xevo TQD IVD System
- Reach sensitivity levels as low as 0.5 ng/mL and standardize tacrolimus results across laboratories, with a proven mean deviation from EQA ALTM of 1.1 %
- Achieve enhanced specificity with this LC-MS/MS kit, which is tailored for the parent drug tacrolimus and is free from cross-reactivity with drug metabolites
- Eliminate the need for method development or validation by using the validated kit method with the ACQUITY UPLC I-Class PLUS/Xevo TQD IVD System
- LC-MS/MS solution
MassTrak Immunosuppressants Kit (IVD) characteristics
MassTrak Immunosuppressants Kit (IVD): Calibrators
- Calibrator set comprising lyophilized tacrolimus in whole blood
- In-use stability: 3 weeks at ≤ -20 °C; 1 week at 2-8 °C
- Shelf life: 53 months when stored at ≤ -20 °C
- Format: 6 x 3 mL (volume for reconstitution)
MassTrak Immunosuppressants Kit (IVD): Controls
- Quality Control Set comprising lyophilized tacrolimus in whole blood
- In-use stability: 3 weeks at ≤ -20 °C; 1 week at 2-8 °C
- Shelf life: 53 months when stored at ≤ -20 °C
- Format: 3 x 3 mL (volume for reconstitution)
MassTrak Immunosuppressants Kit (IVD): Internal standard
- Internal standard solution comprising lyophilized ascomycin
- In-use stability: 3 weeks at a temperature range of 2-8 °C
- Format: 1 x 250 mL (volume for reconstitution)
- Shelf life: 53 months when stored at ≤ -20 °C
MassTrak Immunosuppressants Kit (IVD): Neat solution/tuning mixture
- Mixture adjustment comprising lyophilized tacrolimus and ascomycin
- Shelf life: 53 months when stored at ≤ -20 °C
- Format: 1 x 5 mL (volume for reconstitution)
- Stability during use: 1 week at 2-8 °C
MassTrak TDM C18 Cartridge Column 2.1 x 10 mm
- Durable C18 column designed for online solid-phase extraction (SPE)
- Approved for 500 injections
- P/N: 186002695
Ensure accurate tacrolimus results
In a distinct study, 40 EQA samples (IPT scheme, UK) spanning a concentration range of 1.4 to 21.7 ng/mL were analyzed utilizing the MassTrak Immunosuppressants Kit on the ACQUITY UPLC I-Class PLUS/Xevo TQD IVD System.
All results from the EQA samples fell within ±3 standard deviations of the IPT scheme's mean method. The overall average bias from the method mean across all samples was –5.8 %.
Image Credit: Waters Advanced Diagnostics
Typical concentration values are presented in the table images.
MassTrak Immunosuppressants Kit calibrators and controls contain tacrolimus with 6 x 3 mL target reconstitution volume. Source: Waters Advanced Diagnostics
MassTrak Immunosuppressants Kit Internal standard solution contains ascomycin with a target reconstitution volume of 1 x 250 mL, while the neat solution/tuning mixture contains both ascomycin and tacrolimus with a reconstitution volume of 1 x 5 mL. Source: Waters Advanced Diagnostics
Achieve a high level of precision for the tacrolimus assay
Data from three distinct studies, which used three patient groups (low, medium, high), showed an overall imprecision of less than 8 % across 2.04 ng/mL to 29.9 ng/mL.
Source: Waters Advanced Diagnostics
Improve the laboratory’s efficiency
The MassTrak Immunosuppressants Kit provides an extensive reportable range for tacrolimus, spanning from 0.68 ng/mL to 31.7 ng/mL, thereby eliminating the necessity to dilute samples. This results in fewer retests and more consistent costs.
Image Credit: Waters Advanced Diagnostics
Waters, Xevo, MassTrak, ACQUITY, and UPLC are trademarks of Waters Corporation or its affiliates