NGAL, L-FABP, and KIM-1 in comparison to established markers of renal dysfunction.

Background: New urinary biomarkers like neutrophil gelatinase-associated lipocalin (NGAL), liver-type fatty acid binding protein (L-FABP), and kidney injury molecule-1 (KIM-1) open the opportunity to detect kidney injuries in early stages. Our study aimed at evaluating NGAL, L-FABP, and KIM-1 in comparison to established markers of urine protein differentiation for detection of renal dysfunction.

Methods: On the basis of the PROTIS expert system (for differentiation of glomerulo-/tubulopathy) urine and plasma samples of 263 randomly selected patients were routinely examined (urine: total protein, albumin, IgG, α1-microglobulin, creatinine, and dip stick results for leukocytes, blood, protein, glucose, pH, and nitrite; plasma: creatinine and cystatin C) followed by the analysis of the new urine biomarkers NGAL (CMIA), L-FABP (ECLIA), and KIM-1 (ELISA).

Performance evaluation of a turbidimetric cystatin C assay on different high-throughput platforms.

Objective: The goal with this study was to evaluate the analytical performance of a new cystatin C immunoassay (Tina-quant a Cystatin C, Roche Diagnostics GmbH). The evaluation was carried out at four centers according to a standardized protocol.

Material And Methods: The Tina-quant a Cystatin C is a latex particle-enhanced immunoturbidimetric assay.

Performance of the new mycophenolate assay based on IMPDH enzymatic activity for pharmacokinetic investigations and setup of Bayesian estimators in different populations of allograft recipients.

A new mycophenolate (MPA) assay based on the enzymatic activity of recombinant type II inosine monophosphate dehydrogenase (the pharmacological target of MPA) with excellent correlation with high-performance liquid chromatography has recently been released for the measurement of MPA plasma levels. This study aimed to (1) compare this new assay with liquid chromatography tandem mass spectrometry (LC-MS/MS) for MPA pharmacokinetic (PK) studies in different populations of allograft recipients given mycophenolate mofetil, (2) develop specific Bayesian estimators for this inhibition assay and test their accuracy, and (3) compare the resulting MPA area under the curve (AUC0-12h) estimates with those of Bayesian estimators developed based on the LC-MS/MS results. Sixty-four adult or pediatric, renal or lung transplant patients who were administered mycophenolate mofetil in association with cyclosporine, tacrolimus, or sirolimus at different post-transplant periods were enrolled as part of different PK studies.

Therapeutic drug monitoring and drugs of abuse testing on the cobas 6000 analyzer series: analytical performance under routine-like conditions.

Background: The analytical performance of the clinical chemistry module c 501 (cobas 6000 analyzer series) was evaluated for therapeutic drug monitoring and drugs of abuse testing using a spectrum of representative assays. Particular attention was paid to potential interactions between reagents using a simulated routine workload.

Methods: Within-run and total imprecision were assessed using a selection of representative reagents.

Clinical utility of a new enzymatic assay for determination of mycophenolic acid in comparison with an optimized LC-MS/MS method.

The goal of this study was to investigate the clinical utility of a new enzymatic assay for use on COBAS INTEGRA systems (Roche Total MPA assay). From 134 patients, plasma mycophenolic acid (MPA) concentrations were measured with both the enzymatic method and a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) procedure, to compare these assays. The test principle of the enzymatic assay is inhibition of inosine monophosphate dehydrogenase.

Multicenter evaluation of a new inosine monophosphate dehydrogenase inhibition assay for quantification of total mycophenolic acid in plasma.

The performance characteristics of a new inosine monophosphate dehydrogenase inhibition assay for the quantification of total mycophenolic acid (MPA) in plasma (Roche Diagnostics) were assessed in a multicenter evaluation. Validation data were collected from four institutions. Within-run and total imprecision were acceptable (n = 21 for each of 7 materials, coefficients of variation ranging 0.

Multicentre evaluation of a new assay for determination of carbohydrate-deficient transferrin.

Aims: The analytical performance of the new Tina-quant % carbohydrate-deficient transferrin (%CDT) was assessed in a multicentre study on Roche/Hitachi analysers.

Methods: Intra-assay/total precision studies revealed median coefficients of variation (CVs) of 4.7/7.

Clinical evaluation of the Elecsys CA 15-3 test in breast cancer patients.

The aim of the present study was to evaluate the clinical performance of the CA 15-3 assay on Elecsys systems in an international multicenter study (11 centers). A total of 1326 single samples (272 apparently healthy individuals, 34 pregnant women, 308 benign diseases, 273 cancers other than breast, 439 breast cancer) and 538 serial samples of 98 breast cancer patients during follow-up were analyzed. 95% of values in healthy individuals were below 25 kU/L, and 88% in benign breast diseases, respectively.