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The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies reactive with recombinant human factor VIII (FVII) in human serum and plasma. The Factor VIII Antibody Screen is designed as a solid phase enzyme-linked immunosorbent assay (ELISA) with a colorimetric endpoint. This product is intended to be used as an in vitro diagnostic kit by hemostasis and other laboratories to screen patient samples for the presence of IgG antibodies reactive with human Factor VIII.

The Factor VIII Antibody Screen is an Enzyme Linked Immunosorbent Assay with a colorimetric endpoint. The Factor VIII Antibody Screen is designed to detect IgG antibodies reactive with recombinant human Factor VIII in human serum and plasma. The Factor VIII Antibody Screen kit contains all of the reagents necessary to perform the assay. The Factor VIII Antibody Screen solid phase ELISA microwells provide immobilized recombinant human FVIII as target molecules for the detection of anti-Factor VIII IgG antibodies. Diluted patient serum or plasma is added to microwells coated with recombinant FVIII molecules allowing antibody, if present, to bind. Unbound material is then washed away. An alkaline phosphatase labeled anti-human immunoglobulin reagent (Anti-IgG) is added to the wells and incubated. The unbound Anti-IgG is washed away and the substrate PNPP (p-nitrophenyl phosphate) is added. After a 30 minute incubation period, the reaction is stopped by a sodium hydroxide solution. The optical density of the color that develops is measured in a spectrophotometer at 405 nm with no reference filter.

PF4 IgG™ is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with Platelet Factor 4 (PF4) when it is complexed to polyanionic compounds such as polyvinyl sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy. PF4 IgG™ is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). This product is intended to be used as an in vitro diagnostic kit by hematology, coagulation, or other pathology laboratories to assist in screening patient samples for the presence of heparin-associated antibodies commonly found in patients with heparin-induced thrombocytopenia or thrombosis. PF4 IgG™ is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum. The presence of heparin associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).

The PF4 IgGTM assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG™ ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG™ kit contains all of the reagents necessary to perform the assay. In the PF4 IgG™ assay, a complex of PF4/PVS, which has been immobilized in the microwells serve as a target for the binding of antibodies associated with Type II HIT. In the PF4 IgG™ assay, patient serum is first diluted (1:4), with the specimen diluent provided in the kit. The diluted sample is then added to microwells to which Platet Factor 4 (PF4) complexed to polyvinyl sulfonate (PVS) has been immobilized. The sample is then incubated for 30 minutes at 37°C. If an antibody which recognizes a site on PF4/PVS complex is present in the patient sample, binding will occur. Following this incubation, a wash step then removes any unbound antibodies. A goat anti-human IgG - alkaline phosphatase conjugate is then added to the wells. The conjugate is incubated for 30 minutes at 37°C. Following this incubation, a wash step then removes any unbound conjugate. The alkaline phosphate substrate, p-nitrophenyl phosphate (pNPP) is then added to the microwells. After a 30 minute incubation at room temperature (22 -- 25°C), the reaction is stopped by addition of the stopping solution (3 M sodium hydroxide). The optical density of the color that develops is measured in a spectrophotometer at 405 or 410 nm using a reference wavelength of 490 nm.

GTI PF4 ENHANCED® is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostics kit by hematology, (ELIG/Y). The produce is the pathology laboratories to assist in screening patient samples for the presence of heparin-associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis.

PF4 ENHANCED® Solid Phase ELISA microwells provide immobilized PF4:PVS complexes as a target for the detection of antibodies associated with Type II HIT which are found in some patients undergoing heparin therapy. The presence of these antibodies has been shown to be associated with heparin induced thrombocytopenia Type II (Type II HIT). Patient serum is added to microwells coated with platelet factor 4 (PF4) complexed to polyvinyl sulfonate (PVS). If an antibody recognizing a site on PF4:PVS is present, binding will occur. Unbound antibodies are then washed away. An alkaline phosphatase labeled anti-human globulin reagent (Anti-IgG/A/M) is added to the wells and incubated. The unbound Anti-IgG/A/M is washed away and the substrate PNPP (p-nitrophenyl phosphate) is added. After a 30-minute incubation period, the reaction is stopped by addition of a sodium hydroxide solution. The optical density of the color that develops is measured in a spectrophotometer.

GTI-FVIII Inhibitor Assay is designed as a solid phase Enzyme-Linked Immunosorbent Assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hemostasis and other laboratories providing factor VIII inhibitor assay to assist in screening samples for the presence of alloantibodies to epitopes on FVIII molecule.

FVIII Inhibitor Assay is an ELISA platform which is designed to detect IgG antibodies to human recombinant FVIII in human plasma samples. Recombinant human FVIII molecules are passively immobilized in microtiter wells. Patient plasma is tested against wells containing immobilized recombinant FVIII and compared to the reaction obtained from the negative control sera included in the kit. The results are obtained in optical density (OD) values. The patient samples having OD values greater than the cutoff value are regarded as being positive.

INDICATIONS FOR USE OF GTI-PF4 ELISA FOR THE DETECTION OF ANTIBODIES DIRECTED AGAINST PLATELET FACTOR 4 (PF4):POLYVINYL SULFONATE (PVS) COMPLEX GTI-PF4 ELISA is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hematology, coagulation or other pathology laboratories to assist in screening patient samples for the presence of heparin-associated antibodies commonly found in patients with heparin-induced thrombocytopenia or thrombosis.

GTI-PF4 ELISA is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).