( rop (10 l) of capillary or venous whole...)Prothrombin Time Comes in Small (CLIA-Waived) Packages,Health

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
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