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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.

Related information

KONTAKTA OSS

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

Explore the solution, Immunoassay or HPLC?

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

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.