Clinica chimica acta; international journal of clinical chemistry · 2007
Performance of a no-pretreatment tacrolimus assay on the Dade Behring Dimension RxL clinical chemistry analyzer.
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Griffey Megan A, Hock Karl G, Kilgore Daniel C, Wei Tie Q, Duh Show-Hong, Christenson Robert, Scott Mitchell G
Аннотация
BACKGROUND: Therapeutic drug monitoring for tacrolimus is important for organ transplant patients receiving this immunosuppressant. Current available assays for tacrolimus require sample pre-treatment and operate in a batch mode. Here a no-pretreatment tacrolimus assay, performed on the Dade Behring Dimension analyzer is compared to the Abbott IMx tacrolimus assay and to an LC/MS/MS method.
METHODS: Whole blood samples from 2 medical centers and different transplant types (kidney n=103, liver n=81, heart n=27, pancreas n=16, bone marrow n=9, [corrected] lung n=7), were obtained and tacrolimus quantified by each of the 3 assays.
RESULTS: The lower limit of the linear range was 1.2 ng/ml on the Dimension assay. Total imprecision was 9.8% and within-run imprecision was 9.6% at a tacrolimus concentration of 3.4 ng/dL. Passing-Bablock regression analysis determined the following relationships: DIMN=(1.16) LC/MS - 0.43, r=0.90 and DIMN=(0.99)IMx - 0.35, r=0.87.
CONCLUSIONS: The Dade Behring Dimension [corrected] Tacrolimus assay has adequate imprecision and correlates well with the reference method of LC/MS/MS. The assay appears suitable for clinical use, and has the advantages of not requiring a pretreatment step and the ability to be performed in a random-access mode.
METHODS: Whole blood samples from 2 medical centers and different transplant types (kidney n=103, liver n=81, heart n=27, pancreas n=16, bone marrow n=9, [corrected] lung n=7), were obtained and tacrolimus quantified by each of the 3 assays.
RESULTS: The lower limit of the linear range was 1.2 ng/ml on the Dimension assay. Total imprecision was 9.8% and within-run imprecision was 9.6% at a tacrolimus concentration of 3.4 ng/dL. Passing-Bablock regression analysis determined the following relationships: DIMN=(1.16) LC/MS - 0.43, r=0.90 and DIMN=(0.99)IMx - 0.35, r=0.87.
CONCLUSIONS: The Dade Behring Dimension [corrected] Tacrolimus assay has adequate imprecision and correlates well with the reference method of LC/MS/MS. The assay appears suitable for clinical use, and has the advantages of not requiring a pretreatment step and the ability to be performed in a random-access mode.