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Medizinprodukte Prüfungen >> Unser Angebot >> Quantitative determination of ß-thromboglobulin (ß-TG)

Quantitative determination of ß-thromboglobulin (ß-TG) - in vitro ELISA-Assay

Platelets are present in a large amount in blood (1.5 – 3.5 x 10⁵ cells/µL) and can quickly detect foreign surfaces and initiate blood clotting. Platelet activation can occur through multiple paths associated with medical devices and materials. Activated platelets release bioactive molecules such as β-thromboglobulin (β-TG)^2‑5. Increased β-TG levels in plasma have been reported in different clinical conditions related to platelet activation, including myocardial infarction⁶, prosthetic heart valves⁷, embolism⁷, venous thrombosis⁸ and surgery⁹.

Using a β-TG Enzyme-Linked Immunosorbent Assay (ELISA) kit, the concentration of human β-TG from plasma samples can be measured photometrically to analyze the effect of a test item on platelet activation. A microplate pre-coated with specific rabbit anti-human beta-TG antibodies captures any β-TG present in plasma samples. Next, rabbit anti-β-TG antibodies coupled with peroxidase bind to the remaining free antigenic determinants of the bound β-TG. The bound enzyme peroxidase is revealed by its action on the TMB (tetramethylbenzidine) substrate. The color development is stopped and the intensity of the color is measured photometrically.

The β-TG test is performed in accordance with ISO guidelines 10993-110, 10993-4¹¹ and 10993-12¹² at Eurofins BioPharma Product Testing Munich GmbH.

Procedure

Human whole blood samples are incubated with the test item. After Incubation the Plasma is gained from the blood samples and used to determine complement component concentration using an ELISA based method.

Historical Data

Historical data were generated from 2018 to 2022.

References

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ISO 10993-1: “Evaluation and testing within a risk management process”
ISO 10993-4: “Selection of tests for interactions with blood”
ISO 10993-12: “Sample preparation and reference materials”
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