We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Download Mobile App




Events

09 Apr 2024 - 12 Apr 2024
15 Apr 2024 - 17 Apr 2024
23 Apr 2024 - 26 Apr 2024

Semiautomated Immunoassay for Post-Transplantation Immunosuppressant Assessed

By LabMedica International staff writers
Posted on 29 Apr 2014
Print article
Image: cobas e 411 immunoassay analyzers (Photo courtesy of Roche Diagnostics).
Image: cobas e 411 immunoassay analyzers (Photo courtesy of Roche Diagnostics).
Strategies to improve the long-term preservation of organ function and to reduce the incidence of accompanying diseases such as infections, renal insufficiency, cardiovascular disease and malignancy associated with immunosuppression are increasingly important.

Tacrolimus (TAC) is a post-transplantation immunosuppressant drug used in patients for whom careful monitoring of TAC concentration is essential and a new semiautomated immunoassay for TAC measurements is available and has been assessed in a multicenter evaluation.

A team of scientists from Klinikum-Stuttgart (Stuttgart, Germany) examined residual whole blood samples from patients undergoing TAC therapy after organ transplant and were used in assay evaluation at five clinical laboratories in Europe from October 2012 to April 2013. Studies included imprecision within-run and intermediate, functional sensitivity, linearity, and recovery from external quality assessment scheme (EQAS) samples. The assay was compared to liquid chromatography tandem mass spectrometry (LC–MS/MS) used routinely at each investigational site, and to another commercial immunoassay.

The team evaluated the Elecsys Tacrolimus immunoassay which was developed by developed by Roche Diagnostics for use on the cobas e immunoassay analyzers (Basel, Switzerland). The Elecsys Tacrolimus immunoassay uses the principle of electrochemiluminescence for detection and measurement. This assay was compared with in three centers to an immunoassay from Abbott Architect (Abbott Park, IL, USA) and in five centers to LC–MS/MS analysis.

The investigators observed linearity from 0.5 to 40 μg/L and determined a functional sensitivity of 0.3 μg/L. The within-run imprecision was less than 5.1% on cobas e 602 (5.1% at 1.5 μg/L) and less than 8.9% (8.9% at 0.8 μg/L) on cobas e 411. The intermediate imprecision for TAC concentrations equal to or greater than 6.8 μg/L was less than 6.5%. At lower therapeutic concentrations to 1.5 μg/L, it was consistently less than 10%.

The authors concluded that the assay performed well at all investigator sites, implementation and handling were simple, no deviation from the manufacturer insert information regarding calibration and or reagent stability was observed. The Elecsys Tacrolimus assay has good linearity, functional sensitivity and intermediate imprecision and is comparable to LC–MS/MS methods. The over-all performance of electrochemiluminescence immunoassay demonstrates a modern generation TAC assay that meets the demands of monitoring drug concentrations in current immunosuppressive regimens. The study was published on April 12, 2014, in the journal Clinical Biochemistry.

Related Links:
Klinikum-Stuttgart
Roche Diagnostics
Abbott 


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Specimen Collection & Transport
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Magnetic Bead Separation Modules
MAG and HEATMAG

Print article

Channels

Molecular Diagnostics

view channel
Image: MOF materials efficiently enrich cfDNA and cfRNA in blood through simple operational process (Photo courtesy of Science China Press)

Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis

The ability to diagnose diseases early can significantly enhance the effectiveness of clinical treatments and improve survival rates. One promising approach for non-invasive early diagnosis is the use... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more

Pathology

view channel
Image: The OvaCis Rapid Test discriminates benign from malignant epithelial ovarian cysts (Photo courtesy of INEX)

Intra-Operative POC Device Distinguishes Between Benign and Malignant Ovarian Cysts within 15 Minutes

Ovarian cysts represent a significant health issue for women globally, with up to 10% experiencing this condition at some point in their lives. These cysts form when fluid collects within a thin membrane... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.