Decentralized testing for prothrombin time and activated partial thromboplastin time using a dry chemistry portable analyzer.

Previous work has established the precision and accuracy of a portable blood coagulation analysis system using paramagnetic particles contained in a dry reagent on a disposable test card. We examined the deployment of this technology in decentralized hospital settings and compared test results obtained in the surgical intensive care unit, coronary care unit, and outpatient cardiology clinic with those obtained in the central laboratory. Nursing personnel were instructed in the use of the system, and quality control testing was performed daily by the laboratory staff. In the intensive care units, patient subjects included those on whom tests of prothrombin time and activated partial thromboplastin time had been ordered. Immediate determinations were performed by the intensive care unit nursing staff on the same citrated, whole-blood samples that were subsequently sent to the central laboratory. In the outpatient cardiology clinic, fingerstick blood samples were obtained for prothrombin time determinations with the dry chemistry system. Paired prothrombin time samples obtained by venipuncture were run in the hospital laboratory. The study involved multiple users, multiple locations, two lots of activated partial thromboplastin time cards, and several different instruments, over an extended period. Correlation coefficients between the dry chemistry system and the hospital laboratory under these conditions were in an acceptable range in all sites studied. We concluded that, with appropriate training and quality assurance, the dry chemistry system provides an acceptable alternative to the hospital laboratory for prothrombin time and activated partial thromboplastin time determinations.

Dry reagent technology for rapid, convenient measurements of blood coagulation and fibrinolysis.

Rapid coagulation and fibrinolysis assays suitable for use with an imprecisely measured sample volume (either whole blood or plasma) have been developed, utilizing a technology based on paramagnetic iron oxide particles (PIOP) that move in response to an oscillating magnetic field. PIOP are combined with appropriate test reagents for clotting and thrombolysis assays and formulated as dry reagents within a capillary test chamber. The minima and maxima of the PIOP oscillations define a two-sided waveform that provides kinetic information on fibrin polymerization and lysis. Subject to the chemistry of the dry reagent formulation, the resulting waveform can be used to define clotting time, lysis onset time, or fibrinogen variables. Applications to one-stage prothrombin time and one-stage activated partial thromboplastin time tests have yielded assays with consistently good correlations with other test methods. Applications to fibrinolysis studies have yielded global assays of thrombolytic activity, in that the assay results reflect the interactions of multiple factors associated with the effectiveness of thrombolytic therapy. Depending on the components utilized in a particular reagent formulation, one can derive information about the activity of such factors as fibrinogen, plasminogen, and related inhibitors, as well as the lytic agent being administered. Use of these assays in a clinical setting should provide a rapid, convenient alternative to conventional testing of coagulation variables and a reliable method for monitoring thrombolytic therapy.