Roche cobas b101 HbA1c Testing

Point-of-care HbA1c testing with cobas® b 101

Aid in diagnosis and monitoring of individuals with diabetes

The cobas b 101 HbA1c test from Roche is used with the matching cobas b 101 analyzer as an aid for the diagnosis and long-term monitoring of diabetes. The test provides reliable measurement results of the HbA1c value over a wide measurement range. Thanks to the fast and accurate results, the test is ideallysuited for use in the practice, clinic and laboratory.

Important Notice: For healthcare professionals only.
The test may only be performed and interpreted by a physician or a person authorized by a physician. Medical laypersons may use and interpret the test incorrectly.

Importance of point-of-care (POC) HbA1c testing

Measurement of HbA1c is used to diagnose diabetes and prediabetes in at risk patients and to monitor patients with diabetes.2

	Diabetes is among the top ten leading causes of death globally.1
	In 2021, an estimated 6.7 million individuals died due to diabetes and its complications.1

	Half of all adults with diabetes are undiagnosed.1

• • For determination of HbA1c level in blood
  • Aids in the diagnosis of diabetes and long-term blood glucose monitoring
  • High working safety thanks to application of the sample directly onto the disc
  • For use with the Roche cobas b 101 system
  • Sample material: capillary and venous whole blood
  • Sample volume: 2 μL
  • Measuring time: ≤ 6 minutes
  • Sample stability: 1 minute
  • Measuring range:
    • IFCC: 20 – 130 mmol/mol
    • DCCT/NSGP: 4 – 14 %

cobas® HbA1c test

cobas® HbA1c test is used in POC or clinical laboratory settings, to determine the % hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC), to estimate the average glucose level (eAG).3

	2 μL Fresh capillary blood3 (K2 or K3-EDTA venous whole blood)
	Direct application from single finger prick3

	Shelf life 22 months at room temperature3
	Dual testing with Lipids available – results in < 15 minutes3

Key benefits of cobas® b 101

• Easy and safe handling of samples and test discs
• connectivity and data management
• User-friendly, robust and service-free
• Confirmed performance with full compliance to guidelines*

References

1. International Diabetes Federation. (2021). Diabetes Atlas (10th Edition).
2. Rhea, J.M., Molinaro, R. (2014). Pathology consultation on HbA(1c) methods and interferences. Am J Clin Pathol 141, 5–16.
3. Roche Diagnostics International Ltd. cobas HbA1c Test Method Sheet Version 2.0
4. Commission. European Union. (2016). Certification of the Amount-of-Substance Fraction of HbA1c versus the Sum of HbA0 and HbA1c in Haemoglobin: ERM-AD500/IFCC.