Roche announced that its new, dedicated high-throughput HbA1c testing solution, the cobas c 513 analyser, is now available for countries accepting the CE mark.

"The increasing number of people with diabetes is challenging healthcare providers and is putting a significant strain on healthcare systems," said Roland Diggelmann, COO, Roche Diagnostics. "With the cobas c 513, Roche is meeting the dedicated and growing testing needs of our customers."

With the new cobas c 513 analyser, Roche is replacing its existing dedicated HbA1c analyser, the COBAS INTEGRA 800 CTS, which has been a successful and well-established solution.

The cobas c 513 analyser further increases laboratory efficiency by doubling the already market-leading throughput of the INTEGRA 800 CTS from 200 to 400 patient results per hour. The cobas c 513 achieves this performance with the same footprint.

The cobas c 513 features direct results reporting, thereby minimising the risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. This saves valuable time and laboratory resources while ensuring high quality of results.

Furthermore, the cobas c 513 analyser provides a higher on-board test capacity. Enabling laboratories to load the analyser with more tests at a time saves laboratory space, releases lab resources and ensures a smooth workflow.

The new analyser also offers closed tube sampling, which reduces hands-on time, prevents sample contamination and ensures operator safety for laboratory personnel.

HbA1c is a longer-term measure of blood sugar levels, which is used to determine if a person is diabetic or at risk of developing diabetes.

The cobas c 513 analyser runs the established Tina-Quant HbA1c A1cDx Gen.3 test, which is also used across the Roche laboratory HbA1c portfolio, to ensure high quality of results. It complies with current guidelines and recommendations for HbA1c testing and measures A1c as defined by IFCC.

With no interference by most known HbA1c variants, Roche’s Tina-quant HbA1c assay delivers accurate monitoring of HbA1c levels and results that clinicians and patients can have confidence in.2 Moreover, Roche’s Tina-Quant HbA1c was the first test cleared for diagnosis of diabetes by the FDA.

The cobas c 513 analyser is based on the proven and trusted cobas technology developed in cooperation with Hitachi High-Technologies (HHT).