Tina-quant^® HbA1c Gen. 3

Tina-quant^® HbA1c - Setting a new precedent in HbA1c lab efficiency

Diabetes mellitus, rainking 7th in the top ten global causes of death, has become a worldwide health topic.¹ In 2017, 1 in every 11 adults was diagnosed with diabetes (425 million) with approximately 50% of adults have undiagnosed diabetes.²

HbA1c, which reflects the average glucose level in the last 8-12 weeks, is one of the most widely used test in diabetes management. Current ADA guidelines recommend the HbA1c tests for use in diagnosing type 2 diabetes and prediabetes.^2,3 Therefore, it is critical for the lab to use a standardized assay with good quality to support the right clinical decision.

On cobas^® series platforms, the Tina-quant^® HbA1c assay empowers the laboratory to reduce TAT, optimize operational cost with various solutions, and build confidence on the results for clinical decisions.

• The Tina-quant^® HbA1c assay is available on the platforms with different throughput, eg. cobas INTEGRA 400 plus, cobas c 111, 311, 501/502, 503
• Dedicated high throughput close tube sampling HbA1c system: cobas c 513 (400 samples/hour)

Workflow Efficiency for Operational Cost

• Roche digital diagnostics
• Robustness in cobas^® Series with long MTBRV⁴ time
• Ready-to-use cassette
• Direct result reporting (no result validation needed)
• No sample preparation⁵

Results Accuracy for Clinical Decision

• IFCC (traceable to IFCC ref. method) certified
• NGSP (traceable to DCCT study) certified
• FDA clearance with diagnostics claim⁶
• Result report in duel units: mmol/mol (SI) and % (DCCT)
• Highly specific antibody, no interference of common variants (HbS, C, D, E)⁷
• Excellent CV, eg. cobas c 513 < 1% in DCCT unit⁵
• Good correlation to different methodology standardized⁸