Search Results

The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay is an in vitro diagnostic device designed for the detection of antibodies to Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy. The HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay is a qualitative in vitro diagnostic device designed for the detection of antibodies to the Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy. The risk of heparin induced thrombocytopenia (HIT) is greatly increased in patients with recent exposure to heparin. The presence of heparin/PF-4 antibody is associated with patients arisk. for HIT, and is rapidly becoming a standard of care in hematology and cardinlogy. The need for a rapid test to detect these antibodies from serum or plasma in less than 5 minutes is highly desired. This rapid manual assay should be easily performed when STAT results are required,

The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay consists of two components: a Mini-reactor device containing a membrane filtration system and a results window, and a dispenser containing reaction reagents. The Mini-reactor contains a reaction well that allows the sample to react with the reagents. The sample is added to the reaction well followed by the reagents contained in the reagent dispenser. The reagents contain microparticles coated with purified PF-4 protein as well as additional enhancing agents designed to promote rapid agglutination of the particles in the presence of specific antibodies in the test sample. Once the reagents have reacted with the sample in the reaction well, the reaction mixture automatically collects over the membrane filtration system. This system acts to filter agglutinated particles, while allowing non-agglutinated particles to pass through. Thus, an agglutinated, reactive sample will be trapped within the membrane. Since the dyed particles are trapped by this filter, no particles and hence no color, are able to migrate past the positive/negative line on the results window. Conversely, a nonagglutinated, non-reactive sample will pass through the membrane filter and into the wicking layers, and no color will migrate past the positive/negative line.

The InstaRead™ Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). The test is targeted for physician's office use, and may be used with whole blood, serum, or EDTA-plasma.

The InstaRead™ Lithium System is an in vitro diagnostic device designed to provide accurate and precise measures of patient lithium blood levels using serum or whole blood specimens in an easy to use system that can be utilized at the point of care by non-clinical laboratory personnel. The system consists of three key components: Blood Cell Separator, Lithium Reagent, and InstaRead™ Lithium System photometric reader.

The Blood Cell Separator is intended for the use as a sample preparation aid to in vitro Lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liguid produced by the device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anticoagulant will produce serum.

The Blood Cell Separator is intended for use as a sample preparation aid in in vitro lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The Blood Cell Separator consists of two components packaged in a single separator device: the membrane system and a capillary tube. The device is based upon a multiple layer membrane system designed to separate blood cells and serum/plasma. This is achieved through the attraction and capture of blood cells from a whole blood specimen applied to the surface of the membrane system. The residual liquid continues to flow laterally to the tip of the membrane at which time the capillary tube fills vertically to the pipette's fixed, controlled volume and is ready to use.