Roche has brought out the Elecsys Testosterone II Assay, which features improved accuracy and reduced interference for female samples.
The new Roche Elecsys Testosterone II Assay delivers enhanced accuracy against the Gold Standard ID-GC/MS methods for female samples (in the range of 0.025-1.5ng/ml).
With greatly reduced matrix effect and DHEAS (dehydroepiandrosterone sulphate) interference compared with conventional assays, this automated testosterone assay ensures accurate and reliable results, allowing clinicians to make better clinical decisions about the care of female patients.
The improved performance of the Elecsys Testosterone II Assay is due to the use of a high-affinity testosterone monoclonal antibody.
This antibody allows the assay to deliver optimised recovery of testosterone, even with female samples, and ensures excellent precision, especially at low concentration levels.
It also reduces cross reactivity to DHEAS and susceptibility to matrix effect with female samples, which is a common problem with alternative assays.
The Elecsys Testosterone II Assay demonstrated good correlation with LC-MS/MS for samples from male and female patients and has also shown markedly improved accuracy in haemodialysis patients compared with first-generation assays.
First-generation assays frequently over-estimate testosterone in the female matrix.
This effect is variable and cannot be predicted for any given sample.
The Elecsys Testosterone II Assay has been developed as part of Roche's continued commitment to improvement and in response to customer feedback about high recovery with female samples, which did not fit the clinical picture.
The Elecsys Testosterone II Assay is for use on the Modular Analytics, cobas 8000, cobas 6000, cobas 4000 and Elecsys 2010 platforms.
Roche offers the largest endocrinology menu currently available for automated platforms, which includes fully automated DHEAS, SHBG (sex hormone-binding globulin), Anti-TSHR (thyroid stimulating hormone receptor antibody) and ACTH (adrenocorticotropin hormone) assays.
The short turnaround time of the Elecsys Testosterone II Assay (18 minutes) and small sample-volume required (20ul) improves workflow and allows complete endocrinology panel testing from one patient sample.
