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Tina-quant® HbA1c Gen. 3

Turbidimetric inhibition immunoassay (TINIA) for the in vitro determination of hemoglobin A1c in whole blood or hemolysate

Tina-quant® HbA1c Gen. 3
Tina-quant® HbA1c - Setting a new precedent in HbA1c lab efficiency

Diabetes mellitus, ranking 9th in the top ten global cuases of deaths, has become a worldwide health topic.1 In 2019, more than one in 10 adults is living with diabetes (537 million) with approximately 45% of adults having 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.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.

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The Tina-quant® HbA1c assay aims to meet all of your needs in HbA1c measurement for routine diabetes management. Each and every time!

Testing Throughput for Lab TAT
  • The Tina-quant® HbA1c assay is available on the platforms with different throughput, eg. cobas INTEGRA 400 plus, cobas c 111, 311, 303, 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
Diabetes Panel
  • Glucose
  • Hemoglobin A1c
  • Fructosamine
  • Creatinine
  • Albumin
  • Micro Albumin (Urine)
  • Triglyceride
  • Total cholesterol
  • LDL-cholesterol
  • HDL-cholesterol
  • Urea/BUN
  • Cystatin C
  • C-peptide
  • Insulin

Related analyzers

cobas c 513 analyzer

cobas c 513 analyzer

Setting a new precedent in HbA1c lab efficiency

The cobas c 513 analyzer is a dedicated high throughput HbA1c solution designed to manage the increasing HbA1c testing volume.

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    References

    1. WHO (2020), the top 10 causes of death [online] Available from: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death [last accessed Sep-2022]
    2. IDF Diabetes Atlas 10th Edition, 2021
    3. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes - 2022, ADA
    4. MTBRV: mean time between repair visit, data source: internal report
    5. Tina-quant Hemoglobin A1c Gen. 3 package insert. Roche Diagnostics. 2022.
    6. FDA 510(k), data on file, Roche Diagnostics. 2010
    7. National Glycohemoglobin Standardization Program (2022). HbA1c Assay Interferences. Available from: http://www.ngsp.org/interf.asp [last accessed Sep-2022].
    8. Stéphane Jaisson et al. Evaluation of the analytical performances of the Cobas c513 analyser for HbA1c assay. Biochem Med (Zagreb). 2018 Oct 15; 28(3): 030708.