CoaguChek^® XS Plus system

Coagulation monitoring for healthcare professionals

CoaguChek^® XS Plus provides accuracy, ease of use plus data management for recording patient IDs.

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.

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

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

The CoaguChek^® XS Plus meter features

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

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

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

System specifications

Measuring & sampling

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 conditions

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 material

Sample type

Fresh capillary whole blood or non-anticoagulated venous whole blood

Sample size

≥ 8 μl

Interferences

Refer to the test strip package insert

Test strips

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)

CoaguChek® XS Plus system