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The SPIFE A1AT kit is designed for the qualitative detection of the different phenotypes of Alpha-1 Antitypsin (Al AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 Antitrypsin deficiency. The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agarose gel, performed on the semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-1 Antiserum. For in vitro diagnostic use only.

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The V8 Nexus Hemoglobin UltraScreen method is designed for the separation of normal hemoglobins (A, A2, and F) in human blood samples, and for the detection of major hemoglobins variants (S and C) by using a capillary zone electrophoresis (CZE) buffer with the V8 instrument. The V8 Nexus Hemoglobin UltraScreen test is indicated for use in patients 2 years of age and older. This test is designed for in-vitro diagnostic use only in conjunction with other laboratory and clinical findings.

The V8 instrument is an automated analyzer which performs a complete hemoglobin profile for quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S and C. The assay is performed on the hemolysate of venous whole blood collected in tubes containing K2EDTA as the anticoagulant. The V8 Nexus Hemoglobin UltraScreen method uses capillary zone electrophoresis (CZE) buffer with the V8 instrument for the separation of normal hemoglobins (A, A2, and F) and detection of major hemoglobin variants (S and C). The V8 AFSA2 Hemo Control is a control material derived from whole blood used as a quantitative and/or qualitative control for the Hemoglobin UltraScreen on the V8 Capillary Electrophoresis (CE) system.

V8 SP Normal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System. V8 SP Abnormal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.

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The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's IgG, IgA, IgM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The test results are to be used in conjunction with clinical findings and other laboratory tests. For In Vitro Diagnostic Use Only. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aqqreqation of functional platelets is measured using an electronic impedance-base cell counter.

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The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system. All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification. The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings.

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The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems. Blood coagulation instruments and test systems are used in hospitals and/or catherization labs. The AQC-LP is used as a control when the Actalyke system monitors moderately heparinized patients undergoing ECMO procedures or renal dialysis. The AQC-HP is used for QC testing when the Actalyke system is monitoring normal and highly heparinized patients undergoing cardiovascular procedures.

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The AggRaM Analyzer is a 4-channel aggregometer designed to perform platelet aggregation and Ristocetin cofactor testing on patients for hemostasis abnormalities. Platelet aggregation studies are performed to quantitate platelet response and identify abnormal platelet function. The agonist, Ristocetin, can be used in the diagnosis of von Willebrand's disease. "Nibeoous" reagents are used to quantitate the von Willebrand factor activity.

AggRAM Analyzer

The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis

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