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The cobas b 101 instrument is intended for near-patient testing. Not for self-testing.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Specification", "Value": "  
 
Sample sizeHbA1c 2 μL
Lipid19 μL
CRP12 μL
 
Sample materialHbA1cCapillary whole blood, venous whole blood with anticoagulant (EDTA or heparin)
HbA1c PSTCapillary whole blood
 
LipidsCapillary whole blood, venous whole blood or plasma with anticoagulant (EDTA)
Lipid PSTCapillary whole blood
 
CRPCapillary whole blood or serum, venous whole blood or plasma with anticoagulant (EDTA or heparin)
 
Measurement rangeHbA1c20-130 mmol/mol (IFCC) or 4-14 % (DCCT/NGSP)
 
Lipids:
CHOL50-500 mg/dL or 1.28-12.95 mmol/L
TRIGL45-650 mg/dL or 0.50-7.35 mmol/L
HDL-CHOL15-100 mg/dL or 0.38-2.60 mmol/L
LDL-CHOLestimated using the Friedewald equation
 
CRP3.0-400 mg/L or 0.30-40.0 mg/dL
 
Test storage2-30°C
 
Test stabilityUnopened:
CRP Lipid16 months
HbA1c22 months
 
Opened20 minutes

 ", "Language": "en", "Country": "XG", "Code": "Specification" } ] } } ] }

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

The cobas b 101 system is an IVD test system offering HbA1c, lipid panel and CRP tests at the Point of Care. Fresh capillary blood, K2 or K3-EDTA or lithium heparin anticoagulated venous whole blood can be used for HbA1c. Fresh capillary blood, K2 or K3-EDTA anticoagulated whole blood or plasma can be used for lipids (CHOL, TRIGL, HDL-CHOL, LDL, non-HDL). Fresh capillary blood or serum, K2 or K3-EDTA or lithium heparin anticoagulated whole blood or plasma can be used for CRP. The system delivers fast and reliable results and is intended for professional use in a clinical laboratory or at Point of Care locations.

cobas b 101 system

Lipid disc

Direct sample application (no capillaries, tubes or pipettes are needed) and requires only 19 μL blood volume for lipids test

Lipid disc

HbA1c disc

Direct sample application (no capillaries, tubes or pipettes are needed) and requires only 2 μL blood volume for HbA1c test

HbA1c disc

CRP disc

Direct sample application (no capillaries, tubes or pipettes are needed) and requires only 12 μL blood volume for CRP test

CRP disc
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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

Related information

cobas b 101 system

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    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
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    Overview

    Ordering Information

    Technical Documents

    Access Material Data Sheets, Certificates of Analysis, and other product documentation.

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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:
      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

      2-30 °C

    • Test stability

      Unopened:
      CRP Lipid: 16 months
      HbA1c: 22 months

      Opened: 20 minutes 

       

       

       

       

       

       

       
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