cobas® b 101 system

IVD For in vitro diagnostic use.

Your one-stop solution for HbA1c, lipids, and CRP testing in primary care settings

The cobas® b 101 system is an IVD test system offering HbA1c, lipid panel and CRP tests at the Point of Care. The system delivers fast and reliable results and is intended for professional use in a clinical laboratory or at Point of Care locations.

The cobas b 101 system complies with all relevant standards and methods (International Federation of Clinical Chemistry and Laboratory Medicine [IFCC], Diabetes Control and Complications Trial/National Glycohemoglobin Standardization Program [DCCT/NGSP]).1

A lab technologist holds the pink coloured HbA1c testing disk up to a cobas b 101 system at the Point of Care

Versatile testing with minimal sample requirements

  • Lipid disc: Direct sample application (no capillaries, tubes, or pipettes are needed), requiring only 19 uL of sample. Fresh capillary blood, K2 or K3-EDTA anticoagulated whole blood, or plasma can be used for lipids (TC, TG, HDL-TC, LDL, non-HDL).
  • HbA1c disc: Direct sample application (no capillaries, tubes, or pipettes are needed), requiring only 2 uL of sample. Fresh capillary blood, K2 or K3-EDTA or lithium heparin anticoagulated venous whole blood can be used for HbA1c.
  • CRP disc: Direct sample application (no capillaries, tubes, or pipettes are needed), requiring only 12 uL of sample. Fresh capillary blood or serum, K2 or K3-EDTA, or lithium heparin anticoagulated whole blood or plasma can be used for CRP.
Benefits at a glance

Benefits at a glance

  • Large touchscreen, full keyboard, and multiple language support
  • No calibration needed
  • Maintenance and service-free
  • Guidance by the graphical user interface (GUI)
  • Connection to navify® POC Operations
  • External printer or barcode scanner allow an improved workflow and documentation
  • Data download to a USB stick and then to a PC, or data download to IT solutions installed on PC
  • Direct blood sample application onto the disc from a finger prick (no capillaries, tubes, and pipettes are needed)
  • Requires minimal sample volumes (2 μL for HbA1c, 19 μL for lipids, and 12 μL for CRP)
  • Discs are color-coded and clearly labeled to support correct use.
  • Disc cover concept for operator safety
  • Discs can be stored for more than 16 months at room temperature (2-30 ºC)2,3,4
  • 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

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Overview

Ordering Information

Product specifications

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Product specifications

Specification Value
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: calculated 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: 16 months
Lipid: 16 months
HbA1c: 22 months

Opened:
20 minutes

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References:

  1. F. Hoffmann-La Roche Ltd. Roche Multicenter evaluation. Data on file. 2012.
  2. F. Hoffmann-La Roche Ltd. cobas HbA1c Test Method Sheet (v3.0). 2023.
  3. F. Hoffmann-La Roche Ltd. cobas Lipid Panel Method Sheet (v5.0). 2023.
  4. F. Hoffmann-La Roche Ltd. cobas CRP Test Method Sheet (v2.0). 2023.