Description
CoaguChek® XS PT Test Strip
The CoaguChek® XS PT Test Strip is a single-use in vitro diagnostic test strip designed for use with the CoaguChek® XS system to measure Prothrombin Time (PT) and report results as INR (International Normalized Ratio) and/or %Quick, depending on system configuration. It supports monitoring of oral anticoagulation therapy with vitamin K antagonists (e.g., warfarin) by enabling fast, near-patient testing from a small capillary whole-blood sample. These test strips are intended for professional healthcare use and, where permitted and trained, patient self-testing under medical supervision, following the instructions provided with the meter and strips.
Each strip contains pre-calibrated reagents and quality control features that work with the CoaguChek® XS meter to deliver reliable results when used as directed. The test is performed by applying a drop of fresh capillary whole blood to the target application area. The meter detects the coagulation reaction and calculates the PT-related result. The system is designed to simplify routine anticoagulation monitoring in clinics, physician offices, anticoagulation services, and home settings that follow an approved care plan.
Key Features
- PT/INR testing: Measures PT and provides INR to support anticoagulation monitoring with vitamin K antagonists.
- Small sample requirement: Uses a small capillary whole-blood sample, supporting fingerstick collection.
- Rapid workflow: Designed for quick testing with results available within minutes when used with the CoaguChek® XS meter.
- Single-use format: Individual strips help reduce cross-contamination risk and support consistent performance.
- System integration: Engineered specifically for compatibility with the CoaguChek® XS meter and its built-in controls.
Intended Use
CoaguChek® XS PT Test Strips are intended to be used with the CoaguChek® XS meter to determine PT/INR from capillary whole blood. Results aid in assessing and adjusting anticoagulant therapy as directed by a qualified clinician. These strips are not intended for screening of coagulation disorders in individuals not on anticoagulation therapy unless specifically indicated by the manufacturer’s labeling for your region. Clinical decisions should always consider the patient’s condition, current therapy, and other relevant laboratory and clinical information.
How It Works (Overview)
- Insert a new test strip into the CoaguChek® XS meter as instructed.
- Obtain a fresh capillary whole-blood drop using appropriate lancing and hygiene procedures.
- Apply blood to the strip’s designated application area within the required time window.
- Allow the meter to process the sample and display the PT-related result.
Storage and Handling
- Store test strips only as specified on the product packaging and in the instructions for use.
- Keep strips in their original container and protect from moisture and excessive heat.
- Use each strip immediately after removal from the container and do not reuse.
- Do not use strips past the expiration date or if packaging is damaged.
Compatibility
These strips are intended for use with the CoaguChek® XS meter. Use with other instruments may lead to inaccurate results. Refer to the meter manual and strip instructions to confirm compatibility, required coding/calibration approach for your specific system version, and any applicable limitations.
What’s Included
- CoaguChek® XS PT Test Strips (quantity as specified on the pack label)
- Manufacturer instructions for use (IFU) or access information, depending on pack configuration
For full performance characteristics, measuring range, limitations, and warnings, consult the official CoaguChek® XS PT Test Strip instructions for use and follow local regulations and clinical protocols.
