Roche Diagnostics cobas® click

Product Description

A point-of-care option for near-patient HbA1c, lipid, and CRP testing is the Cobas® Click system. Its user-friendly interface and cutting-edge test disc technology allow for quick testing in clinics, pharmacies, and medical offices.

Duplicate tests can be finished in 15 minutes, while individual test results are accessible in 4-6 minutes. This eliminates the need for long wait times when incorporating test results into clinical decision-making.

The technology combines practical ease of use with excellent accuracy and precision. To reduce interference, the microfluidic test discs have built-in diluents. Triglyceride interference is detected and corrected by a fail-safe system during lipid testing. The purpose of the HbA1c test is to lessen the impact of haemoglobin variations.

Capillary blood samples as little as 2.5 µl are used for testing, enabling direct sampling with a minimal blood volume. Because to its straightforward click closure, the maintenance-free test discs are easy to handle and can be kept at room temperature.

While the embedded barcode scanner makes it easier to identify patients and tests, integrated WLAN, LAN, and USB interfaces provide networking and data management. Up to 5,000 patient results can be stored in the system, and data can be exported for effective documentation and traceability.

Simple operation is supported by a capacitive touchscreen and an easy-to-use interface, and the Cobas® Click system's sturdy architecture makes it possible to incorporate it into current processes. When combined, the system's data management, networking, and testing features offer a workable option for point-of-care diagnostics.

Specifications

• Product: cobas® click point-of-care system
• Application area: Quantitative analysis of clinical-chemical and immunological tests (HbA1c, lipids, CRP)
• Sample material:
  1. Capillary blood
  2. Venous EDTA whole blood
  3. Serum (for CRP)
  4. Plasma (EDTA and lithium heparin, for CRP)
• Sample volume:
  1. HbA1c: 2.5 µl
  2. Lipids: 17 µl
  3. CRP: 13 µl
• Measurement ranges:
  1. HbA1c: 20–130 mmol/mol (IFCC) or 4–14 % (DCCT/NGSP)
  2. Lipids:
     • Total cholesterol (TC): 50–500 mg/dl
     • Triglycerides (TG): 45–650 mg/dl
     • HDL cholesterol: 15–100 mg/dl
     • LDL cholesterol: (calculated from TC, HDL, TG)
  3. CRP: 3.0–400 mg/l or 0.30–40.0 mg/dl
• Measurement time:
  1. HbA1c: < 6 minutes
  2. Lipids: < 6 minutes
  3. CRP: < 4 minutes
• Storage capacity:
  1. Patient results: up to 5,000
  2. User information: up to 3,000
  3. Patient data: up to 3,000
  4. Quality control results: up to 500
• Device interfaces:
  1. USB (PC connection)
  2. USB (for USB stick or printer)
  3. RJ45 LAN port
  4. Integrated WLAN module
• Display: Capacitive touchscreen
• Dimensions: 135 × 184 × 234 mm (W × H × D)
• Weight: 2.0 kg (without power supply)
• Operating temperature: 15–32 °C
• Storage temperature of test discs: 2–30 °C
• Relative humidity: 10–85 % (non-condensing)
• Maximum operating altitude: 3,000 m
• Automatic functions:
  1. Programmable shutdown (1–999 minutes)
  2. Programmable automatic logout (1–60 minutes)
  3. Programmable bypass of lock tests (1–9 tests)
• Maintenance requirements: No maintenance except cleaning and disinfection
• Standards and guidelines:
  1. Complies with Regulation (EU) 2017/746 on in vitro diagnostics
  2. Complies with IEC 61326-2-6:2020 for electromagnetic compatibility
  3. Conformity with Directive 2011/65/EU (RoHS)
• Scope of delivery:
  1. cobas® click device
  2. User documentation
  3. Power supply and mains cable

Application Scope

• Diabetology
  1. Long-term monitoring of glycaemic control through precise HbA1c determination
  2. Support in therapy adjustment and optimisation
• Cardiology
  1. Lipid profile analysis for assessment of cardiovascular risk
  2. Rapid availability of cholesterol and triglyceride values for risk evaluation
• Internal Medicine / General Practice
  1. Differential diagnosis of inflammatory processes through CRP measurement
  2. Support of antibiotic management through reliable CRP values
• Emergency Medicine
  1. Timely decision-making in critically ill patients through rapid laboratory results
• Outpatient Care and Practice Laboratory
  1. Efficient patient care through point-of-care tests without delays from external laboratories
  2. Improvement of workflow and documentation processes through integrated connectivity
• Pharmaceutical Counselling in Pharmacies
  1. Monitoring of at-risk patients as part of health checks
  2. Support in therapy recommendations based on valid test results

Technical Specifications

• Dimensions: 135 × 184 × 234 mm (W × H × D)
• Weight: 2.0 kg (without power supply)
• Display: Capacitive touchscreen
• Memory:
  • 5,000 patient results
  • 3,000 patient information records
  • 3,000 user information records
  • 500 quality control results
• Interfaces: USB (PC), USB (USB stick/printer), RJ45 LAN, integrated WLAN
• Measurement time:
  • HbA1c: < 6 minutes
  • Lipids: < 6 minutes
  • CRP: < 4 minutes
• Sample volume:
  • HbA1c: 2.5 µl
  • Lipids: 17 µl
  • CRP: 13 µl
• Storage temperature of test discs: 2–30 °C
• Operating temperature of device: 15–32 °C
• Relative humidity: 10–85 % (non-condensing)
• Maximum operating altitude: 3,000 m
• Noise emission: max. 65 dB (A)
• Automatic functions: shutdown (programmable 1–999 min), automatic logout (programmable 1–60 min), bypass lock tests (programmable 1–9 tests)
• Maintenance: None required except cleaning and disinfection
• Power supply: 12 V DC
• Standards: Complies with IEC 61326-2-6:2020 (EMC), Regulation (EU) 2017/746, RoHS Directive 2011/65/EU

Usage Operation

• Turn on the device and wait until the main menu is displayed after the self-check.
• Ensure that the date and time are set correctly to guarantee precise documentation.
• Select the “Patient test” option in the main menu and enter the patient ID by scanning or manual input.
• Open the test disc packaging and remove the disc without touching the test surface.
• Prepare the capillary blood collection:
  1. Ask the patient to wash their hands thoroughly with soap and warm water and dry them to promote blood circulation.
  2. Disinfect the puncture site with an alcohol swab and allow it to dry.
  3. Use a sterile lancet with the recommended puncture depth (e.g., 3 for lipid tests).
  4. Puncture the side of the fingertip and remove the first drop of blood to avoid contamination.
• Carefully apply the blood volume to the sample inlet of the test disc until the transparent spot is completely covered.
• Close the disc cover with a “click”. Once closed, reopening is not possible.
• Immediately insert the test disc into the device and close the device cover to start the automatic measurement.
• Wait for the result, which will be displayed after approximately 4 to 6 minutes.
• Confirm the completion of the test via the display and dispose of the disc properly.
• Use the integrated connectivity options for easy data management and documentation in the daily work in a medical practice.
• Perform regular cleaning and disinfection of the device to ensure operational safety; maintenance is not required.

Scope of Delivery

• 1× cobas® click device
• 1× power supply unit
• 1× mains power cable
• 1× user documentation (operating instructions)
• Consumables are not included and are available separately:
  1. cobas® HbA1c test discs Gen. 2 (20 pieces per pack)
  2. cobas® Lipid Panel test discs Gen. 2 (20 pieces per pack)
  3. cobas® CRP test discs Gen. 2 (20 pieces per pack)
• Optional accessories and controls are also available separately for quality assurance and optimal use