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Prothrombin Time Comes in Small (CLIA-Waived) Packages


Determining prothombin levels is necessary to plan or evaluate anticoagulant therapy, to diagnose various inherited conditions, such as hyperhomocystinemia, elevated factor VIII levels, dysfibrinogenemia, factor XII deficiency and disorders of plasmin generation, and to assess acquired conditions, such as pregnancy, postoperative state, antiphospholipid syndrome, hyperhomocystinemia, among others. Prothrombin levels are also monitored along with other tests (such as aspirate aminotransferase and alanine aminotransferase) to help evaluate liver function. Given the broad applicability of this test, it is helpful to many clinicians that several point-of-care products are now available for the prompt, accurate determination of prothombin levels.

Prothrombin time (PT) is the sole test used to measure the effectiveness of coumarin-type anticoagulant drugs, such as warfarin sodium (Coumadin). The most common methods to report the PT are the clotting interval (in seconds) and the International Normalized Ratio (INR). Targets for the INR vary, depending on the reason for anticoagulation. For example, a patient having hip surgery, who is being anticoagulated to prevent deep vein thrombosis, may have a target INR of between two and three. To prevent arterial thrombosis in a patient with an artificial heart valve, the INR therapeutic goal may be in the 2.5- to 3.5-range.

Several medical manufacturers have gained CLIA-waived status for their PT test devices, allowing rapid assessment in the point of care setting, and, in the cases of several waived-devices, in the patients home as well. Roche Diagnostics Corporation, Indianapolis, Ind., a division of Swiss F. Hoffmann-La Roche Ltd, produces the CoaguChek S System, designed for health care professionals to enable on-the-spot analysis of coagulation levels during mobile emergency treatment, in hospital and in general practice. The device employs electromagnetic field kinetics to determine PT. A single d
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