GP-1 Reagent kit for the determination of heparin anti-Xa activity by optical method with chromogenic substrate ("Reachrom-heparin") according to TU 9398-032-05595541-2011
GP-1/1 Reagent kit for determination of heparin antiXa activity by chromogenic method
The GP-1 kit is intended for automatic, semi-automatic analyzers, as well as for manual determination of anti-Xa activity.
The GP-1/1 kit is only for automatic coagulometers.
Method principle:
The method of determining heparin activity is based on the ability of the AT III-heparin complex to neutralize activated factor Xa. Heparin activity is determined in plasma by adding an excess of AT III and factor Xa to it. In this process, factor Xa is inhibited by the AT III-heparin complex in proportion to the amount of heparin in the plasma. The remaining amount of factor Xa catalyzes the cleavage of para-nitroaniline (pNA) from the synthetic chromogenic substrate. The absorption of free pNA, determined at a wavelength of 405 nm, is inversely proportional to the heparin activity in the plasma. The process follows the scheme: AT III (excess) + heparin → AT III-heparin. AT III-heparin + Xa (excess) → AT III-heparin-Xa+Xa (remainder). Substrate-pNA + Xa (remainder) ⇒ Peptide + pNA. To construct a calibration curve, calibrator plasmas with known heparin activities, indicated in the medical device passport, are used. On the ordinate axis (Y) on a linear scale, optical density values obtained for each calibrator plasma are plotted, and on the abscissa axis (X) on a linear scale, heparin activity is plotted in anti-Xa units/ml of plasma. The correctness of the calibration curve construction is monitored using control plasmas.
Composition of the GP-1 kit:
• Antithrombin III 2х1 ml;
• Factor Xa 2х2 ml;
• Chromogenic substrate 2х2 ml;
• Buffer concentrated 2х5ml;
• Calibrator plasmas of 3 levels LWMH (0, 0.4-0.7, 0.8-1.2 IU/ml 3х1 ml;;
• Control plasmas 2 levels (0.4-0.7, 0.8-1.2 IU/ml) 2х1 ml.
Kit GP-1 for 20 tests using the manual method.
Composition of the GP-1/1 kit:
• Antithrombin III 2х1 ml
• Factor Xa 4x12 nkat
• Chromogenic Substrate 2x3.0 mkM
• Buffer Imidazole 1x5 ml
• Calibration Plasma 3 levels (0, 0.4-0.7, 0.8-1.2 IU/ml) 3x1 ml
• Control Plasma 2 levels (0.4-0.7, 0.8-1.2 IU/ml) 2x1 ml
Kit GP-1/1 for at least 80 tests using the automatic method. The number of tests depends on the type of coagulometer used.
