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- 28 Tem 2021
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According to the American College of Cardiology, point-of-care (POC) coagulation analyzers that measure prothrombin time/international normalized ratio (PT/INR) on fingerstick capillary blood are used to assist in the monitoring of patients who are receiving oral anticoagulant therapy (OAT) with vitamin K antagonists. Anticoagulant medications such as warfarin (Coumadin), phenprocoumon (Marcumar), and acenocoumarol (Sintrom, which is also available under other brand names) are examples of what is available.
It is necessary to monitor the agents on a regular basis because they have a limited therapeutic window and because the patient's diet, particularly if they consume vitamin K-rich foods such as green leafy vegetables, can have an impact on their effectiveness. Because warfarin has a very narrow therapeutic range, physicians can make immediate and often more frequent adjustments to anticoagulant dosage by using PT/INR results rather than laboratory Coagulation Analyzer testing. This eliminates the need to wait for results from laboratory Coagulation Analyzer testing, which can take several hours or longer. Point-of-care PT/INR measurements and clinical laboratory PT/INR measurements have been shown to be highly consistent time and time again, demonstrating excellent agreement. Nonetheless, a cloud has been cast over the future of point-of-care testing following the 2016 withdrawal from the market of a manufacturer's PT/INR monitoring systems, which were pulled from the market due to the systems' alleged inaccuracy in producing low reading. The advancements the industry is making to ensure the accuracy of device results can be relied upon by healthcare professionals and patients seeking reassurance that point-of-care PT/INR testing is still safe and effective for monitoring Coagulation Analyzers.
Those who suffer from atrial fibrillation, which is a common cardiac arrhythmia that affects an estimated 2.7-6.1 million people in the United States3, are at greater risk for blood clots, including those that cause ischemic strokes. It is common practice to prescribe OAT to patients in order to lower their risk of stroke; however, the use of these medications is typically accompanied by frequent patient monitoring through blood tests. There has been an increase in the number of patients on warfarin therapy, which has coincided with a trend toward testing outside of the laboratory, which has increased the demand for reliable PT/INR results on portable, easy-to–use point–of–care (POC) hemodynamic analyzers.
A common tool in the monitoring of OAT is the INR, a mathematical adjustment of the PT that was introduced to standardize Coagulation Analyzer values, as well as the interpretation of the results of the test. When a thromboplastin manufacturer provides an ISI number, it is used to calculate an INR. The ISI number is based on the mathematical comparison of an individual lot of the drug with a reference standard that has been internationally recognized for its sensitivity and specificity.5 Commercial point-of-care analyzers provide results in both PT seconds and INR units, and they employ disposable reagent test strips that are both convenient and biosafe.
Some point-of-care productsInfrared PT/INR analyzers are small, portable, and lightweight devices that are designed to be used effectively with little or no training or expertise. It is possible to reduce the length of a patient's visit from three hours or more to less than 30 minutes if they do not require invasive venous blood draws in outpatient settings where they are receiving warfarin anticoagulant therapy. A dosage adjustment can be made during the patient visit if necessary because there is no need to wait for a laboratory result. When there is no delay, as well as the increased frequency of assessment and adjustment in treatment that POC PT/INR testing allows, a patient's chance of maintaining time in therapeutic range (TTR) is greatly increased. In studies, it has been demonstrated that rapid point-of-care coagulation testing improves the time to resolution. six, seven, and eightIt has been reported that increasing the amount of time spent in TTR lowers the likelihood of having a heart attack. Lower TTR duration is associated with higher rates of recurrent deep vein thrombosis and major bleeding in patients with atrial fibrillation and other heart conditions, as well as an increased risk of ischemic stroke in patients with these conditions.
It is necessary to monitor the agents on a regular basis because they have a limited therapeutic window and because the patient's diet, particularly if they consume vitamin K-rich foods such as green leafy vegetables, can have an impact on their effectiveness. Because warfarin has a very narrow therapeutic range, physicians can make immediate and often more frequent adjustments to anticoagulant dosage by using PT/INR results rather than laboratory Coagulation Analyzer testing. This eliminates the need to wait for results from laboratory Coagulation Analyzer testing, which can take several hours or longer. Point-of-care PT/INR measurements and clinical laboratory PT/INR measurements have been shown to be highly consistent time and time again, demonstrating excellent agreement. Nonetheless, a cloud has been cast over the future of point-of-care testing following the 2016 withdrawal from the market of a manufacturer's PT/INR monitoring systems, which were pulled from the market due to the systems' alleged inaccuracy in producing low reading. The advancements the industry is making to ensure the accuracy of device results can be relied upon by healthcare professionals and patients seeking reassurance that point-of-care PT/INR testing is still safe and effective for monitoring Coagulation Analyzers.
Those who suffer from atrial fibrillation, which is a common cardiac arrhythmia that affects an estimated 2.7-6.1 million people in the United States3, are at greater risk for blood clots, including those that cause ischemic strokes. It is common practice to prescribe OAT to patients in order to lower their risk of stroke; however, the use of these medications is typically accompanied by frequent patient monitoring through blood tests. There has been an increase in the number of patients on warfarin therapy, which has coincided with a trend toward testing outside of the laboratory, which has increased the demand for reliable PT/INR results on portable, easy-to–use point–of–care (POC) hemodynamic analyzers.
A common tool in the monitoring of OAT is the INR, a mathematical adjustment of the PT that was introduced to standardize Coagulation Analyzer values, as well as the interpretation of the results of the test. When a thromboplastin manufacturer provides an ISI number, it is used to calculate an INR. The ISI number is based on the mathematical comparison of an individual lot of the drug with a reference standard that has been internationally recognized for its sensitivity and specificity.5 Commercial point-of-care analyzers provide results in both PT seconds and INR units, and they employ disposable reagent test strips that are both convenient and biosafe.
Some point-of-care productsInfrared PT/INR analyzers are small, portable, and lightweight devices that are designed to be used effectively with little or no training or expertise. It is possible to reduce the length of a patient's visit from three hours or more to less than 30 minutes if they do not require invasive venous blood draws in outpatient settings where they are receiving warfarin anticoagulant therapy. A dosage adjustment can be made during the patient visit if necessary because there is no need to wait for a laboratory result. When there is no delay, as well as the increased frequency of assessment and adjustment in treatment that POC PT/INR testing allows, a patient's chance of maintaining time in therapeutic range (TTR) is greatly increased. In studies, it has been demonstrated that rapid point-of-care coagulation testing improves the time to resolution. six, seven, and eightIt has been reported that increasing the amount of time spent in TTR lowers the likelihood of having a heart attack. Lower TTR duration is associated with higher rates of recurrent deep vein thrombosis and major bleeding in patients with atrial fibrillation and other heart conditions, as well as an increased risk of ischemic stroke in patients with these conditions.