Search Results

The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. The technological characteristics are the same for all STA R Max® Family and STA Compact Max® family analyzers, including STA R Max 30 and STA Compact Max 30, which is based on two measurement principles: Chronometric measurement principle and Photometry measurement principle. The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available reagents. The instrument performs multiple test methodologies in random access, as selected by the user. These include clotting time or clot-based tests (i.e. chronometric measures) and photometric assays on plasma samples. Changes include a redesigned PSR module to replace the Hamilton syringes and Valcor pump of the fluidic circuit and the addition of the HIL module for estimating interferences (Hemoglobin, Icterus, Lipemia).

The STA- NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma (3.2% sodium citrate), of Prothrombin Time (PT) on STA-R family, STA Compact family and STA Satellite family instruments. STA- NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).

The in-vitro diagnostic STA® - NeoPTimal kits are available in two sizes and contains: STA® - NeoPTimal 5: 6 x 5 ml vials of Reagent 1, 6 x 5 ml vials of Reagent 2 STA® - NeoPTimal 10: 12 x 10 ml vials of Reagent 1, 12 x 10 ml vials of Reagent 2 Reagent 1 is STA® - NeoPTimal, lyophilized thromboplastin prepared from rabbit brain extract. The STA® - NeoPTimal reagent contains a specific heparin inhibitor. Any prolongation of the prothrombin time is, therefore, related to a real deficiency of factor II, V, VII, X and/or fibrinogen. Reagent 2 is a solvent containing calcium. The test consists of the use of calcium thromboplastin to measure the clotting time of the patient's plasma and to compare it with that of a normal standard. The test measures, as a whole, the activities of the coagulation factor II (prothrombin), factor V (proaccelerin), factor VII (proconvertin), factor X (Stuart factor) and factor I (fibrinogen). The PT value is expressed in seconds or INR. The result has to be interpreted according to the patient's clinical and biological states. The INR value corresponds to the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used: INR = ( Patient's PT / Mean Normal PT ) * ISI The ISI value of a given thromboplastin is determined by testing normal plasma and VKA (vitamin K antagonist)-treated patient plasma with that thromboplastin and with the International Reference preparation (RBT) for thromboplastin.

The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liates® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.

STA® - Liatest® D-Di kit contains: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies (8D2 and 2.1.16) stabilized with bovine albumin. The test principle is based on the change in turbidity of a microparticle suspension that is measured by photometry. A suspension of latex microparticles, coated by covalent bonding with monoclonal antibodies specific for D-dimer is mixed with the test plasma for which the D-dimer level is to be assayed. An antigen-antibody reaction takes place, leading to an agglutination of the latex microparticles which causes an increase in turbidity of the reaction medium. This increase in turbidity is reflected by an increase in absorbance, the latter being measured photometrically. The increase in absorbance is a function of the D-dimer level present in the test sample.

The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. The device consists of a cuvette, a metal ball, three needles, oscillation amplitude detection, a light source and sensor, and software.

The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liates® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and as an aid in the diagnosis of deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.

STA® - Liatest® D-Di kit contains: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies (8D2 and 2.1.16) stabilized with bovine albumin. The test principle is based on the change in turbidity of a microparticle suspension that is measured by photometry. A suspension of latex microparticles, coated by covalent bonding with monoclonal antibodies specific for D-dimer is mixed with the test plasma for which the D-dimer level is to be assayed. An antigen-antibody reaction takes place, leading to an agglutination of the latex microparticles which causes an increase in turbidity of the reaction medium. This increase in turbidity is reflected by an increase in absorbance, the latter being measured photometrically. The increase in absorbance is a function of the D-dimer level present in the test sample.

The STA® - Coag Control (N + ABN) PLUS is a kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels. Each kit provides: 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized. 12 x 2-ml vials of Reagent 2 (STA® - Coag Control ABN PLUS), citrated abnormal human plasma, lyophilized. STA® - Coag Control (N+ ABN) PLUS Reagents are used as controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line. Analyzers of the STA® line utilize the chronometric principle (viscosity based detection system) for clotting tests while the chromogenic assays are based on the photometric method (measurement of absorbance of monochromatic light).

The STA Compact Max® is a fully automatic clinical analyzer designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Diagnostica Stago's STA Compact Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA Compact® analyzer (K093167). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. The device consists of a cuvette, a metal ball, three needles, oscillation amplitude detection, a light source and sensor, and software.

The STA® - Liquid Anti-Xa kits are intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. The STA® - Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity. The STA® - Quality HNF/UFH kit is a set of two plasmas intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers. The STA® - Quality HBPM/LMWH kit is a set of two plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The STA® - Liquid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity. The method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely, hydrolysis of the substrate by factor Xa and inhibition of factor Xa by the heparin-antithrombin complex. After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium. The STA® - Multi Hep Calibrator reagents are lyophilized human plasmas at five different heparin concentrations. They are used to create the calibration curve on STA-R®, STA Compact®, and STA Satellite® analyzers performing the chromogenic method for heparin (UFH and LMWH) using STA® - Liquid Anti-Xa. The STA® - Quality HNF/UFH reagents are lyophilized human plasmas at two different UFH concentrations. They are used for the quality control of UFH activity assay by measuring the anti-Xa activity using the chromogenic method STA® - Liquid Anti-Xa performed on STA-R®, STA Compact®, and STA Satellite® analyzers. The STA® - Quality HBPM/LMWH reagents are lyophilized human plasmas at two different LMWH concentrations. They are used for the quality control of LMWH activity assay by measuring the anti-Xa activity using the chromogenic methods, STA® - Liquid Anti-Xa and STA® - Rotachrom® Heparin, performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The STA® - Hybrid Hep Calibrator is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity using the chromogenic method, STA® - Rotachrom® Heparin.

The STA® Hybrid Hep Calibrator is a set of lyophilized human plasmas used to create the calibration curve on the STA® line of IVD instruments performing the chromogenic method for heparin (UFH and LMWH) assays. Each STA® Hybrid Hep Calibrator available contains: 4 x 1-ml vials of Reagent 1: STA® Hybrid Hep Calibrator O lyophilized human plasma free of heparin. 4 x 1-ml vials of Reagent 2: STA® Hybrid Hep Calibrator 3 lyophilized human plasma containing a well-defined quantity of UFH. 4 x 1-ml vials of Reagent 3: STA® Hybrid Hep Calibrator 6 lyophilized human plasma containing a well-defined quantity of UFH that is greater than that of Reagent 2. 4 x 1-ml vials of Reagent 4: STA® - Hybrid Hep Calibrator 9 lyophilized human plasma containing a well-defined quantity of LMWH. 4 x 1-ml vials of Reagent 5: STA® Hybrid Hep Calibrator 18 lyophilized human plasma containing a well-defined quantity of LMWH that is greater than that of Reagent 4.

The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.

The STA® - Liatest® Free PS test kit is comprised of a suspension of latex microparticles coated with two (2) different mouse monoclonal anti-human free protein S antibodies stabilized with bovine albumin. Also in the test kit is an HEPES buffer. Testing is carried out in citrated human plasma via the immunoturbidimetric method utilizing external calibrator plasmas for the STA® - Liatest Free PS (the predicate device is pre-calibrated, not utilizing external calibrator plasmas).