CoaguChek® XS Plus system

Coagulation monitoring for healthcare professionals

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PT/INR Monitoring tailored to a healthcare professional’s needs

Test your patients’ PT/INR right in your practice instead of waiting for lab results. All three CoaguChek XS devices use the same testing technology. So the CoaguChek XS Plus and Pro produce results equivalent to those obtained with reference laboratory methods and also compare closely to the patient’s device, the CoaguChek XS.

CoaguChek XS Plus system has the CLIA-waived status. The point-of-care anticoagulation monitor offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the CLIA of 1988.1

 

Accurate and flexible technology–a smart way to test

 

  • Accurate, precise results in about one minute2
  • The only system to perform onboard quality control and patient tests in a single test chamber
  • Results unaffected by heparin at therapeutic levels3
  • INR corrected for hematocrit within specified range

 

Streamlined data management

 

  • Stores 2000 patient and 500 QC test results
  • Operator and QC lockout to ensure your policies are followed
  • Calibration via code chip
  • Stores lot data for up to 60 codes
CoaguChek XS plus system

System components

  • 1 CoaguChek XS Plus instrument
  • 1 Handheld power supply unit
  • 1 printed manual in English
  • 1 CD-ROM with other languages: German, French, Italian,
  • English, Spanish, Portuguese, Danish, Norwegian, Swedish, Finnish and Dutch

 

Optional accessories

 

  • Handheld base unit kit: docking station (to reload the battery pack and transfer data to a computer)
  • Handheld battery pack: option instead of standard batteries or power supply (to gain flexibility)

 

Additional required components

 

CoaguChek XS PT Test strips (in a vial)

  • Box with 2 vials of 24 strips with a code chip
  • Box with 1 vial of 24 strips with a code chip

Optional international 1 level CoaguChek XS PT-control kit including:

  • 4 vials with a concentration of ~ 2.0 INR
  • 4 diluent-filled droppers
  • 1 code chip
  • Package insert

References

 

  1. Roche Diagnostics, Method Sheet CoaguChek XS PT Test, 2017, US version.
  2. Roche Diagnostics, User Manual CoaguChek XS Plus System, 2009.
  3. Roche Diagnostics, Method Sheet CoaguChek XS PT Test, 2018, EU version.

Technical specifications

Technical specifications

Detection system
 

Amperometric (electrochemical) determination of the PT/INR after activation of the coagulation with human recombinant thromboplastin

 

User interface
 

Full graphical (TFT)

 

Support and safety functions
 

QC lockout, Patient & User ID, protection with administrator ID

 

Sample application
 

Outside the meter, with top-and 2 sides (left or right)-dosing options

Operating temperature
 

+15° C to +32 °C (59 °F to 90 °F)

 

Operating humidity and altitude
 

10 - 85% - 4300 m

 

Handling
 

  • First option: Operate the monitor on a level surface, free of vibrations
  • Second option: hold the monitor in your hand, so that it is roughly horizontal

 

Measuring range
 

INR: 0.8 - 8.0; %Q: 120 - 5; SEC: 9.6 - 96

 

Memory
 

  • 2000 patient and 500 QC results with date and time.
  • 60 code chip records.
  • Operator lists with up to 5000 Operator IDs with corresponding 2nd ID.
  • Patient lists with up to 4000 Patient IDs with corresponding 2nd and 3rd IDs.

 

Interface
 

Infrared interface

 

Power options
 

  • Power supply adaptor: input: 100 - 240 V / 50 - 60Hz / 400 mA; output: 7.5 V DC/ 1.7 A
  • 4 x 1.5 V AA batteries (alkali - manganese)
  • Rechargeable battery pack (optional)

 

Number of tests per set of batteries
 

Approx. 80 tests (approx. 60 tests per charging cycle if the rechargeable battery pack is used)

 

Dimensions
 

185 x 97 x 43 mm

 

Weight
 

311 g (without batteries)

Sample type
 

Fresh capillary whole blood or non-anticoagulated venous whole blood

 

Sample size
 

≥ 8 μl

 

Interferences
 

Refer to the test strip package insert

ISI
 

Approx. 1.0

 

Sensitivity to heparin
 

Not at therapeutic levels, up to 0.8 I.U/ml for UFH and to 2 anti - Xa.U/ml for LMWH

 

Quality control
 

On each strip, through the same channel as the blood passes

 

Stability
 

21 months from production (+ 2° C to + 30° C)