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, rainking 7th in the top ten global causes of death, has become a worldwide health topic.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 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, 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
Product image for 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.

  1. WHO (2018). The top 10 causes of death. [online] Available at: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death [Accessed 23 Jul. 2019]
  2. IDF Diabetes Atlas 8th Edition, 2017
  3. Standards of Medical Care in Diabetes, 2018, ADA
  4. MTBRV: mean time between repair visit, data source: internal report
  5. Package insert
  6. FDA 510(k), data on file, Roche Diagnostics. 2019. 
  7. National Glycohemoglobin Standardization Program (2019). HbA1c Assay Interferences. Available from: http://www.ngsp.org/interf.asp (accessed July 2019).
  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.