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cobas b 101 system

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 profile and CRP tests at the Point of Care. Fresh capillary blood, K2 or K3-EDTA venous whole blood or plasma (lipids only) can be used. The system delivers fast and reliable results and is intended for professional use in a clinical laboratory setting or at point-of-care locations.

Lipid disc

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

HbA1c disc

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

CRP disc

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

Do you have any questions?

Guideline compliant performance

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

Easy and safe operation

Direct blood application from a single finger stick with small volume
No calibration needed, maintenance and service-free, graphical guidance for simplified use

Fast turnaround time

From patient preparation to displaying dual results in a 15-minute workflow and a single test in less than 6 minutes (CRP 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 the cobas POC IT solution
External printer or barcode scanner allow an improved workflow and documentation
Data download to USB stick or direct to PC is possible

Disc Features

Direct sample application (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 for high operator safety
Discs can be stored for more than 13 months at room temperature (2 - 30 ºC)^2,3,4

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

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

2 to 30 °C
Test stability

Unopened: 13 - 16 months
Opened: 20 minutes

References

Roche (2012). multi-center evaluation data on file.
Roche (2014). cobas HbA1c Test Package Insert, Version 3.0.
Roche (2014). cobas Lipid Panel Package Insert, Version 4.0.
Roche (2017). cobas CRP Test Package Insert, Version 1.0.