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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 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.

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

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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

Overview

Ordering Information

Technical Documents

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

Document repository

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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