Navigation Links
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 rop (10 l) of capillary or venous whole blood is applied to a test strip containing thromboplastin, initiating the coagulation cascade. Alternating magnetic fields in the cocktail cause pre-incorporated iron particles in the strips reaction chamber to move. An endpoint is reached when the formation of a clot causes immobilization of these particles.

The company says that the system includes one of the fastest coagulation meters available, with results available within one minute. The hand-held meter is icon-based, with a large, easily read display. The open sample-application area and flashing light make sample targeting easy. The meter recognizes errors and controls are identified automatically. Automatic internal controls monitor the meter and test strip for accurate function.

International Technidyne Corp., Edison, N.J., manufactures the ProTime Microcoagulation System, which uses fingerstick whole blood samples and displays test results as INR and PT interval in four to five minutes. It consists of a ProTime instrument, a reagent cuvette and the Tenderlett Plus incision device. It has also been approved for patient self-testing, and is available by prescription. According to the company, only ProTime runs two levels of quality control with each patient's sample and is the only PT analyzer that automatically runs quality control with every test.

HemoSense, Inc., San Jose, Calif., manufactures the HemoSense INRatio meter, which also provides results in PT and INR within two minutes, using fresh capillary whole blood.

The device features automatic self-testing and includes a quality control system. The company reports that the INRatio meter has an easy to use interface to change the time, date and other features, a large screen, storage for up to 60 tests and a built-in communication port.

The three firms reviewed here represent all of the CLIA-waived devices currently in production. The medical device field changes rapidly and previously available products sometimes vanish from the market. This has recently happened with two additional CLIA-waived PT monitors, the Harmony INR Monitoring System produced by LifeScan, Inc., and the AvoSure system from Avocet Medical, Inc. (Beckman Coulter, Inc. has acquired the rights to the AvoSure technology).

Despite sudden shifts in some products, the availability and increasing sophistication of point of care diagnostic devices is clearly a permanent and positive development. Use of these products saves time and expense, promotes effective continuity of care and enhances convenience for patients and caregivers alike.
'"/>




Related medicine technology :

1. New Advances in Gastric Diagnostics: Smaller is Better
2. Bench-Top Centrifuges--Basic Tools for the Small Lab

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... May 24, 2016 Een app ... zodat zij collectief patiënten kunnen behandelen, hun kennis kunnen ... idee achter de nieuwe en revolutionaire MDLinking App, ontwikkeld ... Nederlandse vaatchirurg dr. Hans Flu en oncologisch chirurg dr. ... inmiddels beschikbaar is, wordt op dinsdag 24 mei officieel ...
(Date:5/23/2016)... FLINT, Mich. , May 23, 2016 Diplomat ... the third annual Fellowship and Internship programs. The hands-on ... 12. The full-time, paid Fellowship ... Flint, Michigan . Fellows and interns are ... downtown Flint at the Riverfront ...
(Date:5/23/2016)... , May 23, 2016 ... Devices, Diagnostics and Monitoring, and Vision Care ... Which areas are going to grow at the fastest ... revenues to 2026, assessing data, trends, opportunities and prospects. ... charts, and graphs. Discover the most lucrative areas in ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... 25, 2016 , ... Casa Velas, an adults-only boutique hotel in Puerto Vallarta, ... its new wellness suites . The two 1,350 sq. ft. suites which debuted ... services and insuite amenities, from a custom soap selection and in-suite exercise kit to ...
(Date:5/25/2016)... , ... May 25, 2016 , ... America Walks ... Carol Reichbaum, M.S.L., M.S.P.A., of the University of Pittsburgh Graduate School of Public ... will enable Ms. Reichbaum and 24 other advocates from around the country to participate ...
(Date:5/25/2016)... ... May 25, 2016 , ... "FCPX LUT Intense allows ... your footage," said Christina Austin - CEO of Pixel Film Studios. , With ... and easily add stylish color grades to their footage. A LUT is a Lookup ...
(Date:5/25/2016)... ... May 25, 2016 , ... Consumer access to organic foods ... 2016, Kashi®, a maker of whole grain cereals and other plant-based foods, will introduce ... hard red winter wheat processed by Hesco/Dakota Organic Products. , The transitional designation ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... Stern ... firm will be selling the device branded as Stern’s Real Time Monitoring ... to bedbugs to the hotel and motel industry, colleges for use in dormitories, shelters, ...
Breaking Medicine News(10 mins):