cobas b 101 POC system

b101_3

One system to manage diabetes and dyslipidemia at the point of need

  • IVD test system offering HbA1c and a complete lipid profile (CHOL, HDL, LDL, TG, non-HDL, TC/HDL) on one device at the Point of Care
  • Capillary blood, whole blood and plasma* can be used
  • Fast and reliable results 
  • Intended for professional use in a clinical laboratory setting or point-of-care locations

*Plasma for Lipid Panel only



  • User-friendly with large touchscreen, full keyboard and multiple language support
  • Maintenance- and calibration-free with wide operating temperature and humidity range
  • Connectivity to POC IT solutions
  • External printer or barcode scanner enable improved workflow and documentation 

Parameters and measurements in therapeutic range

  • HbA1c disc:
    • IFCC: 20 – 130 mmol/mol
    • NGSP: 4 – 14 %
    • eAG*: 68 – 356 mg/dL



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  • Lipid disc:
    • CHOL: 50 – 500 mg/dL
    • TG: 45 – 650 mg/dL
    • HDL: 15 – 100 mg/dL
    • LDL*: 1– 476 mg/dL
    • Non-HDL and TC/HDL (calculated)



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Disc features

  • Sample volume from one finger stick
  • Fast and easy with direct sample application (no capillaries, tubes or pipettes needed)
    • HbA1c ≤2 µ L in ≤340 sec
    • Lipids ≤19 µ L in ≤385 sec
  • Discs are color-coded and clearly labeled to ensure correct use
  • Shelf life of more than 13 months
  • Both capillary and venous whole blood can be used for lipids and HbA1c testing
  • Lipid testing can also be done with plasma







Parameters and measuring range  in the therapeutic important range

  • HbA1c disc:

– IFCC: 20 – 130 mmol/mol
– NGSP: 4 – 14 %
– eAG*: 68 – 356 mg/dL

(calculated out of HbA1c)

  •  Lipid disc:

– CHOL: 50 – 500 mg/dL
– TG: 45 – 650 mg/dL
– HDL: 15 – 100 mg/dL
– LDL*: 1– 476 mg/dL
– Non-HDL and TC/HDL*

A step forward in the management of metabolic syndrome

The cobas b 101 system is an IVD test system that delivers benefits in a number of key areas:

Test precision and guideline compliant

  • Adheres to all relevant standards and methods (IFCC/ DCCT/NGSP and CDC/NCEP)

Easy and safe operation

  • Both tests can be performed from one finger prick
  • No calibration needed
  • Monitor sample integrity
  • Full process control
  • Configure how results are displayed

Fast turnaround time

  • Intuitive 15 min workflow from patient preparation to result of both HbA1c and lipid panel

1. cobas b 101 system-performance evaluation

This multicenter study evaluated the performance of the new cobas b 101 system which provides the measurement of both HbA1c and lipids from whole blood (including total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TG) and calculated low density lipoprotein (LDL), non-HDL and TC/HDL ratio) at the Point of Care.

In this study, both the precision and reproducibility of the cobas b101 measurement were evaluated as well the result equivalence to a reference system. All results matched the acceptance criteria defined at the beginning of the study, confirming the usability and practicability of the cobas b 101 in a point-of-care environment. The acceptance criteria were defined according to the National Glycohemoglobin Standardization Program (NGSP), the Clinical and Laboratory Practice Institute (CLSI) and the National Cholesterol Education Program (NCEP) guidelines.

2. HbA1c
Immediate Feedback of HbA1 c Level s Improves Glycemic Control in Type 1 and Insulin - Treated Type 2 Diabetic Patients
Cagliero E et al. (1999). Diabetes Care 22: 1785–1789
Summary: Immediately available HbA1c results lead to significantly decreased level at 6 and 12 months in the POC group (-0.57 ± 1.44 and -0.40 ± 1.65%, respectively; p < 0.01)




3. Metabolic syndrome
NCEP-Defined Metabolic Syndrome, Diabetes, and Prevalence of Coronary Heart Disease Among NHANES III Participants Age 50 Years and Older
Alexander et al (2003). Diabetes 52:1210–1214
Summary: Metabolic syndrome significantly increases the risk of CHD events in individuals with diabetes




4. Lipid panel
Evaluation of a pharmacist-managed lipid clinic that uses point-of-care lipid testing
Gerrald et al (2010). J Clin Lipidol 4:120–125
Summary: lipid panel testing at the lipid clinic improved NCEP goal attainment and therefore improve lipid management