CoaguChek^®XS system

Point-of-Care PT/INR testing made easier

With the CLIA waived CoaguChek XS system, accuracy and convenience are right at hand. This small, handheld, battery-powered meter is ideal for low- to mid-volume office settings. Plus, you can test and treat in one appointment using the fingerstick test that patients prefer.¹ In fact, more INR tests are performed in the United States with the CoaguChek XS meter than all other INR meters combined.²

Designed for comfort, convenience and easy reporting:

Easy to use. The CoaguChek XS meter features two-button operation, automatic power-on and a large, easy-to-read display. Just one drop of blood is applied to the test strip to measure clotting time.

Fast results. The CoaguChek XS displays INR results in about a minute.

The support you need. If you or your patients have questions, live technical support is available by phone.
1-800-428-4674

Do you have any questions?

Get accurate, consistent results:

Consistent. CoaguChek solutions provide confidence in clinical decision making with 97% correlation to the lab.³

Accurate. CoaguChek technology reduces heparin interference for more accurate results.⁴

+References

^{1. Giles T and Roffidal L. Results of the Prothrombin Office-Testing Benefit Evaluation (PROBE). Cardiovascular Reviews and Reports. 2002;23(1):27-33.

2. GHX Market Intelligence. Data on file at Roche Diagnostics.

3. 97% correlation with lab results using Dade Innovin reagent on a Sysmex 560 Analyzer. See CoaguChek XS PT test strip package insert for more information.

4. See CoaguChek XS PT Test package insert for more information.}

CoaguChek® XS system

The CoaguChek® XS system is a convenient, portable and user-friendly instrument for monitoring warfarin therapy. It determines the INR value (International Normalized Ratio) from a drop of capillary whole blood –simple, precise and reliable.

Do you have any questions?

I feel like I got my passport back.

The CoaguChek XS system is ready for use anywhere at any time. Patients can use it for self-monitoring at home or while on vacation.

Fast, reliable results

Accurate PT/INR results in one minute
Built-in quality control checks every strip automatically
Lab-comparable accuracy1

Simple fingerstick test

Most patients prefer having a small drop of blood (just 8 μL) taken from a fingerstick to having blood drawn from a vein3

Improved patient outcomes

Patients who self test have been shown to spend more time in therapeutic range and have less thrombembolic events2

Detection system

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

User interface: Icon-based LCD display; on/off, mem and set buttons

Measuring range

INR: 0.8 - 8.0

%Quick: 120 - 5

Seconds: 9.6 - 96

References

Kitchen, D.P., Munroe, S., Kitchen, S., Jennings, I., Woods, T.A.L., Walker, I.D. (2008). Results from the first year of an external quality assessment programme for the users of CoaguChek XS and CoaguChek XS Plus for monitoring INRs. British Journal of Haematology, Volume 141 Supplement 1: P188
Heneghan, et. al (2006). Lancet, 367; 404-411
Woods, K., Douketis, J.D., Schnurr, T., Kinnon, K., Powers, P.et al. (2004). Patient preferences for capillary vs. venous INR determination in an anticoagulation clinic : a randomized controlled trial. Thromb Res 114(3), 161-165.

Technical specifications

Operating conditions

Temperature

+ 15° C to + 32° C (59° F to 90° F)
Relative humidity

Less than 85% (without condensation)
Maximum altitude

4,300 m (14,000 ft)
Placement

Operate the monitor on a level, vibration-free surface or hold it so it is roughly horizontal
Measuring range INR

0.8 -8.0
Interface

Infrared
Power

Battery - Four 1.5v AAA alkali-manganese batteries

# of tests per set of batteries

Up to 300 tests or 2 years
Size

138 x 78 x 28 mm
Weight

127 g (without batteries)
Memory

Up to 300 test results (including date and time)

Measuring & Sampling

Detection system

Electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin
User interface

Simple user interface with icon-based liquid crystal display (LCD), on-off, memory and set button
Sample application

Within 15 seconds of pricking the fingertip, apply the blood to the target area of the test strip—either from the top or side of the test strip.

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

International Sensitivity Index (ISI)

Approximately 1.0
Sensitivity to heparin
Testing performed with the following in vitro spiked samples or native blood samples (triglycerides) indicated no significant effect on test results:
- Heparin concentrations up to 0.8 U/mL
- Low molecular weight heparins (LMWH) up to 2 IU anti‑factor Xa activity/mL
Quality control

Integrated into the meter and test strips and automatically run for every blood test
Stability

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