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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

The device concerned is the ASSERACHROM® tPA Test Kit, an ELISA-based assay for the quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma.

Acceptance Criteria and Reported Device Performance

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