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Related Concept Videos

Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
Pulse Assessment Sites01:11

Pulse Assessment Sites

Pulse assessment sites are crucial in evaluating a patient's cardiovascular health. By assessing the pulsations of arteries at specific anatomical locations, healthcare professionals can gather valuable information about blood flow, heart rate, and peripheral circulation. Understanding these pulse assessment sites is essential for conducting comprehensive cardiovascular evaluations and monitoring patients' overall health. These sites are strategically chosen due to the accessibility and...
Effects of EDTA on End-Point Detection Methods01:18

Effects of EDTA on End-Point Detection Methods

Different methods, such as visual observance of metal-ion indicators, spectroscopic techniques, and potentiometric methods, can determine the endpoint of an EDTA titration.
In the visual method, metal-ion indicators (metallochromic dyes), which have distinct colors in their free and complex forms, are added to the mixture to signal the titration's end point. They form stable complexes with metal ions, but these complexes are weaker than the corresponding metal–EDTA complexes. As a result, EDTA...
Instrumentation Amplifier01:25

Instrumentation Amplifier

An electrocardiography (ECG) machine is an essential piece of medical equipment used to monitor the electrical activity of the heart. It operates by detecting small electrical changes on the skin that result from the depolarization of the heart muscle during each heartbeat. However, these signals are in the microvolt range and can be easily overwhelmed by noise or interference.
To overcome this challenge, an ECG machine utilizes an instrumentation amplifier. This specialized amplifier is...
Equipments Used To Measure Blood Pressure01:30

Equipments Used To Measure Blood Pressure

Direct Method
This invasive approach involves cannulating a peripheral artery. During each cardiac contraction, pressure generates mechanical motion within the catheter, transmitted through rigid, fluid-filled tubing to a transducer. This transducer converts mechanical motion into electrical signals displayed as waveforms on a monitor. An automatic flushing system prevents blood backflow. Due to the potential risk of unexpected arterial blood loss, this method is primarily used in intensive...
Electrocardiogram01:29

Electrocardiogram

An electrocardiogram (ECG or EKG) is a critical diagnostic tool that records the electrical signals produced by the heart during each heartbeat. This recording is achieved through electrodes placed strategically on the arms, legs, and chest. The electrocardiograph amplifies these signals and produces 12 distinct tracings, offering a comprehensive understanding of the heart's electrical activity.
Three major waveforms are present in a typical ECG recording: the P wave, the QRS complex, and the T...

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Endotoxin Activity Assay for the Detection of Whole Blood Endotoxemia in Critically Ill Patients
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External quality assessment (EQA) for CoaguChek monitors.

Joergen Jespersen1, Leon Poller, A M H P van den Besselaar

  • 1Department of Clinical Biochemistry, Hospital of South West Denmark.

Thrombosis and Haemostasis
|March 11, 2010
PubMed
Summary

External quality assessment (EQA) for CoaguChek monitors is crucial for accurate anticoagulation therapy. A simpler ECAA/ECAT EQA system identified significant deviations in 20.3% of devices, highlighting the need for regular monitoring.

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Area of Science:

  • Medical Devices
  • Clinical Diagnostics
  • Hematology

Background:

  • Anticoagulant therapy monitoring is overwhelmed, leading to treatment delays.
  • Point-of-care testing devices like CoaguChek are increasingly used for patient self-management.
  • European Commission directives mandate external quality assessment (EQA) for patient self-monitoring devices.

Purpose of the Study:

  • To assess the effectiveness of a simplified EQA system for CoaguChek monitors.
  • To evaluate the performance of CoaguChek devices used in patient self-management.
  • To determine the frequency of significant International Normalized Ratio (INR) deviations in CoaguChek monitors.

Main Methods:

  • A collaborative assessment involving the European Concerted Action on Anticoagulation (ECAA) and European Concerted Action on Thrombosis (ECAT).
  • Testing of 523 CoaguChek monitors across nine clinics using a standardized procedure.
  • Utilized a set of 5 plasma samples with certified International Normalized Ratios (INR) for performance evaluation.

Main Results:

  • A deviation of 15% or more from the certified INR on a single plasma sample defined unacceptable performance.
  • 106 out of 523 tested monitors (20.3%) exhibited significant INR deviations.
  • A higher incidence of deviations was noted with a specific lot of test strips.

Conclusions:

  • Regular EQA of CoaguChek monitors is essential for ensuring accurate anticoagulation therapy.
  • The simplified ECAA/ECAT EQA procedure effectively identifies monitors with unacceptable performance.
  • Recommended EQA intervals are every six months or upon changing test strip lots.