CLSI POCT14
Point-of-Care Coagulation Testing and Anticoagulation Monitoring
CLSI POCT14 offers expert advice for users and manufacturers of point-of-care coagulation testing devices. Explore guidance for monitoring heparin and vitamin K antagonist therapy, evaluating hemostasis, and keeping your results in synch and reliable across medical laboratories.
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{{FormatPrice(nonMemberPrice)}} List PriceThis guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point of care (POC). These tests include those used for monitoring vitamin K antagonists (VKAs) (eg, prothrombin time/international normalized ratio [PT/INR]) and heparin (eg, activated partial thromboplastin time [APTT], activated clotting time [ACT], and heparin concentration). POCT14 also includes recommendations for use of point-of-care testing (POCT) when APTT and PT/INR are used to evaluate individuals for suspected coagulopathies before or after invasive procedures or in association with the administration of certain pharmaceutical agents. This guideline provides minimal reference to the use of point-of-care coagulation testing (POC-CT) for monitoring direct thrombin inhibitors (DTIs). Potential assay interferences, including direct oral anticoagulants (DOACs), are briefly discussed. The intended users of this guideline are manufacturers, regulatory organizations, and health care professionals. Recommendations are provided on how to assess accuracy and precision of traditional coagulation assays, as well as how to assess clinical safety and effectiveness. This guideline does not cover other hemostasis assays such as viscoelastic tests, either thromboelastometry or thromboelastography, or POC platelet function tests.
This guideline replaces the previous edition of the approved guideline, CLSI POCT14-A, published in 2004.
Several changes were made to this edition, including:
• Added assay-specific performance criteria for both manufacturers and end users
• Provided recommendations for performance criteria for the use of Point-of-Care Coagulation Testing (POC-CT) for the evaluation of patients with suspected bleeding disorders
This guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point-of-care (POC). These tests include those used to monitor vitamin K antagonists (VKAs) (eg, prothrombin time/international normalized ratio [PT/INR]) and heparin (eg, activated partial thromboplastin time [APTT], activated clotting time [ACT], and heparin concentration).
CLSI POCT14 also includes recommendations for use of point-of-care testing (POCT) when APTT and PT/INR are used to evaluate individuals for suspected coagulopathies before or after invasive procedures or in association with the administration of certain pharmaceutical agents. This guideline provides minimal reference to the use of point-of-care coagulation testing (POC-CT) for monitoring direct thrombin inhibitors (DTIs). Potential assay interferences, including direct oral anticoagulants (DOACs), are briefly discussed.
The intended users of this guideline are manufacturers, regulatory organizations, and health care professionals. Recommendations are provided for how to assess the accuracy and precision of traditional coagulation assays, as well as how to assess clinical safety and effectiveness. This guideline does not cover other hemostasis assays such as viscoelastic tests, thromboelastometry or thromboelastography, or POC platelet function tests.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point of care (POC). These tests include those used for monitoring vitamin K antagonists (VKAs) (eg, prothrombin time/international normalized ratio [PT/INR]) and heparin (eg, activated partial thromboplastin time [APTT], activated clotting time [ACT], and heparin concentration). POCT14 also includes recommendations for use of point-of-care testing (POCT) when APTT and PT/INR are used to evaluate individuals for suspected coagulopathies before or after invasive procedures or in association with the administration of certain pharmaceutical agents. This guideline provides minimal reference to the use of point-of-care coagulation testing (POC-CT) for monitoring direct thrombin inhibitors (DTIs). Potential assay interferences, including direct oral anticoagulants (DOACs), are briefly discussed. The intended users of this guideline are manufacturers, regulatory organizations, and health care professionals. Recommendations are provided on how to assess accuracy and precision of traditional coagulation assays, as well as how to assess clinical safety and effectiveness. This guideline does not cover other hemostasis assays such as viscoelastic tests, either thromboelastometry or thromboelastography, or POC platelet function tests.
This guideline replaces the previous edition of the approved guideline, CLSI POCT14-A, published in 2004.
Several changes were made to this edition, including:
• Added assay-specific performance criteria for both manufacturers and end users
• Provided recommendations for performance criteria for the use of Point-of-Care Coagulation Testing (POC-CT) for the evaluation of patients with suspected bleeding disorders
This guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point-of-care (POC). These tests include those used to monitor vitamin K antagonists (VKAs) (eg, prothrombin time/international normalized ratio [PT/INR]) and heparin (eg, activated partial thromboplastin time [APTT], activated clotting time [ACT], and heparin concentration).
CLSI POCT14 also includes recommendations for use of point-of-care testing (POCT) when APTT and PT/INR are used to evaluate individuals for suspected coagulopathies before or after invasive procedures or in association with the administration of certain pharmaceutical agents. This guideline provides minimal reference to the use of point-of-care coagulation testing (POC-CT) for monitoring direct thrombin inhibitors (DTIs). Potential assay interferences, including direct oral anticoagulants (DOACs), are briefly discussed.
The intended users of this guideline are manufacturers, regulatory organizations, and health care professionals. Recommendations are provided for how to assess the accuracy and precision of traditional coagulation assays, as well as how to assess clinical safety and effectiveness. This guideline does not cover other hemostasis assays such as viscoelastic tests, thromboelastometry or thromboelastography, or POC platelet function tests.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.