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STA-R® Automated Multi-Parametric Analyzer is a fully automatic 311 TV Tratomated for the performance of tests on human ellinear in the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA-R® instrument is a fully automatic laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once test samples and reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of test results are performed automatically, making the STA-R® instrument a true "walk-away" system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization. The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently commercially available from third-party manufacturers. Bar-coding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the utilization of non barcoded reagents. The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.

The ASSERACHROM® tPA test kit is intended for the quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma by the sandwich technique of enzyme immunoassay (EIA) known as enzyme-linked immunosorbent assay (ELISA). The quantitative determination of tPA is generally performed during the assessment of the fibrinolytic system of a patient, for instance, following a thrombotic episode. In addition, it has been reported that a high antigenic level of tPA is associated with a greater risk of myocardial infarction or vascular cerebral accident. Finally, quantitative tPA assays are useful in the detection of hypofibrinolytic and hyperfibrinolytic states.

The ASSERACHROM® tPA test kit is intended for the quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma by the sandwich technique of enzyme immunoassay (EIA) known as enzyme-linked immunosorbent assay (ELISA). Mouse monoclonal anti-tPA antibody is coated on the inside wall of a plastic microwell. The plasma to be tested is allowed to incubate in the microwell for two hours at room temperature, during which any tPA present is captured by the monoclonal antibody. Next, a second (and different) mouse monoclonal anti-tPA antibody coupled with peroxidase is added to the microwell for another 2-hour incubation at room temperature; this antibody-enzyme conjugate binds to another antigenic determinant of the tPA molecule that is already bound to the microwell in the first incubation step. The bound enzyme is revealed by its action on orthophenylenediamine in the presence of hydrogen peroxide to produce a yellow color; after addition of a strong acid to stop the enzymatic action, the intensity of the color developed bears a direct relationship to the tPA level initially present in the test plasma. The kit provides sufficient reagents to perform 96 tests in micro-ELISA plate format. Reagents in intact (unopened) kits remain stable for 18 months after their date of manufacture, when stored at 2°-8°C. Reconstituted reagent stabilities are as follows: Reagent ● (antibody-coated microwell strips) must be used immediately after opening of its package; Reagent @ (anti-tPA-Peroxidase), 24 hours at 2°-8°C; Reagent Oa (ortho-Phenylenediamine) dissolved together with Reagent Ob (Urea Peroxide), 1 hour at room temperature (18°-25°C); 1:10 diluted Reagent © (Dilution Buffer) and 1:20 diluted Reagent ® (Washing Solution), 15 days at 2°-8°C, when free of any contamination; both the Reagent ® (tPA Calibrator) and Reagent ® (tPA Control), 4 hours at 20°C. The ASSERACHROM® tPA reagent system has a detection limit of 1 ng/ml; a working range from 1 ng/ml up to the tPA level of Reagent ® (tPA Calibrator, up to 50 ng/ml); intra-assay reproducibility of < 6.5%; inter-assay reproducibility of < 8%.

The STA® Liatest® Control [N]+[P] kit is intended for use as control plasmas (Normal and Abnormal levels) for von Willebrand Factor (vWF) and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

The STA®-Liatest® Control [N]+[P] kit provides two citrated human plasmas intended for use as normal and abnormal controls for von Willebrand Factor (vWF) and D-dimer antigen assays by the immino-turbidimetric method performed on STA® analyzers (Diagnostic Stago, France: STA® full-size model and STA® Compact model). Each STA®-Liatest® Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at normal levels (STA®-Liatest® Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at abnormal levels (STA®-Liatest® Control [P]). Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board STA® analyzers.

The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers to perform quantitative assays of D-dimer antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific mouse anti-human D-dimer monoclonal antibodies. Each STA®-Liatest® D-Di test kit provides: 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 mouse anti-human D-dimer monoclonal antibodies. Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials, kit reagents (with STA®-Reducers and perforated caps installed on the vials) are stable for 15 days on board STA® analyzers.

The STA® D-Di Calibrator kit is intended for use as a calibration plasma for D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

The STA® D-Di Calibrator is a citrated human plasma containing D-dimer at a known level, intended for use as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model and STA® Compact model). Each STA® D-Di Calibrator kit provides 6 x 1-ml vials of citrated human plasma in lyophilized form. The D-dimer value of each lot is indicated in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board STA® analyzers.

The STA® -Liatest® vWF test kit is intended for use with the STA® analyzer to perform quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of fight absorbance produced by a suspension of microlatex particles coated with specific anti-vWF antibodies.

Each STA®-Liatest vWF test kit provides: 4 x 5-ml vials of ready-for-use glycine buffer; 4 x 2-ml vials of a suspension of microlatex particles coated with rabbit antihuman vWF antibodies; 4 x 4-ml vials of diluent solution containing glycine for dilution of the latex reagent before use. Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials or after dilution, kit reagents are stable for 15 days on board the STA® analyzer.

The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level, intended for use as a calibration plasma for the assay of vWF antigen by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level. Each manufactured lot of STA®-vWF Calibrator is assigned a vWF value which is determined with an internal VWF reference that has been assayed against the third International Standard 91/666 for Factor VIII and von Willebrand Factor established in 1992. Each STA®-vWF Calibrator kit provides 6 x 1-ml vials of citrated human plasma in freeze-dried form. The vWF value of each lot is provided in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board the STA® analyzer.

The STA® vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (vWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

Each STA®-VWF Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF at the normal level (STA®-vWF Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF at the abnormal level (STA vWF Control [P]). Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board the STA® analyzer.

The STA Compact instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA Compact instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once samples and test reagents are loaded onto the instrument, sample handling. reagent delivery, analysis and reporting of test results are performed automatically, making the STA Compact instrument a true walkaway system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization. The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently available from third-party manufacturers. Barcoding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.