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cobas® b 101 system

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

IVD For in vitro diagnostic use.
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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

  • User friendly benchtop device
  • Easy blood sample application onto disc from a finger prick
  • No calibration needed, maintenance and service-free, guidance by the graphical user interface (GUI)

Fast turnaround time

  • Single testing with HbA1c, lipid panel and CRP, or dual testing with HbA1c and lipid panel tests
  • Single test results are available in about 6 minutes (CRP less than 4 minutes) and dual testing results are available after a workflow of under 15 minutes

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 blood sample application onto disc from a finger prick (no capillaries, tubes and 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

References

  1. Roche Multi center evaluation. Data on file (2012)
  2. Roche cobas HbA1c Test Method Sheet V 2.0 (2019)
  3. Roche cobas Lipid Panel Method Sheet V 5.0 (2019)
  4. Roche cobas CRP Test Method Sheet V 2.0 (2019)

Overview

Ordering Information

Technical Documents

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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

     

     

     

    Lipids: 
    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:
    TC: 50-500 mg/dL or 1.28-12.95 mmol/L
    TG: 45-650 mg/dL or 0.50-7.35 mmol/L
    HDL-TC: 15-100 mg/dL or 0.38-2.60 mmol/L
    LDL-TC: estimated using the Friedewald equation

     

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

  • Test storage

    2-30 °C

  • Shelf life

    Unopened:
    CRP Lipid: 16 months
    HbA1c: 22 months

    Opened: 20 minutes 

     

     

     

     

     

     

     

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