cobas b 101 system

One-stop solution for HbA1c, lipids, and CRP testing in the Primary Care Setting

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Guideline compliant performance

  • cobas b 101 system complies with all relevant standards and methods (IFCC, DCCT/NGSP)1

 

Easy and safe operation

 

  • Direct blood application from a single finger stick with small volume
  • No calibration needed, maintenance and service-free, guidance by the graphical user interface (GUI)

 

Fast turnaround time

 

  • From patient preparation to displaying dual testing results in a less than 15-minute workflow and single testing results in about 6 minutes (CRP in less than 4 minutes)
  • A choice of single HbA1c, lipid panel and CRP testing or dual HbA1c and lipid panel tests

 

System characteristics

 

  • User-friendly with a large touchscreen, full keyboard, and multiple language support 
  • Robust, maintenance-and calibration-free with a wide operating temperature and humidity range
  • Connection to cobas® infinity POC IT solutions
  • External printer or barcode scanner allow an improved workflow and documentation
  • Data download to USB stick and then to a PC or data download to IT solutions installed on PC.

 

Disc Features

 

  • Direct sample application from finger (no capillaries, tubes or pipettes are needed)
  • Requires only very small sample volumes (2 μL for HbA1c, 19 μL for lipids and 12 μL for CRP)
  • Discs are color-coded and clearly labelled to support correct use.
  • Hinge cover concept for operator safety
  • Discs can be stored for more than 16 months at room temperature (2 - 30 ºC)2,3,4
cobas b 101 system

Product specifications

  • Sample size

    HbA1c: 2 μL
    Lipid: 19 μL
    CRP: 12 μL

  • Sample material

    HbA1c:
    Capillary whole blood, venous whole blood with anticoagulant (EDTA or heparin)
    HbA1c PST: 
    Capillary whole blood

    Lipid: 
    Capillary whole blood, venous whole blood or plasma with anticoagulant (EDTA)
    Lipid PST: 
    Capillary whole blood

    CRP: Capillary whole blood or serum, venous whole blood or plasma with anticoagulant (EDTA or heparin)

     

  • Measurement range

    HbA1c:
    20 - 130 mmol/mol (IFCC) or 4–14 % (DCCT/NGSP)

     

    Lipid:
    CHOL: 50–500 mg/dL or 1.28–12.95 mmol/L
    TRIGL: 45–650 mg/dL or 0.50–7.35 mmol/L
    HDL-CHOL: 15–100 mg/dL or 0.38–2.60 mmol/L
    LDL-CHOL: estimated using the Friedewald equation

     

    CRP: 
    3.0–400 mg/L or 0.30–40.0 mg/dL

     

     

     

  • Test storage

    2 to 30 °C

  • Test stability

    Unopened:
    CRP Lipid: 16 months
    HbA1c: 22 months

    Opened: 20 minutes 

     

     

     

     

     

     

     

References

 

  1. Roche (2012). multi-center evaluation data on file.
  2. Roche (2019) cobas HbA1c Test, Method Sheet Version 2.0
  3. Roche (2019) cobas Lipid Panel, Method Sheet Version 5.0
  4. Roche (2019) cobas CRP Test, Method Sheet Version 2.0