Thrombophilia is a predisposition — congenital or acquired — to form blood clots, which carries a risk of thrombosis. Exploration of the causes of a venous thromboembolism event (VTE) combines a clinical examination and a hemostasis assessment including the thrombophilia test panel of the coagulation bench.

Our study

Amarok Biotechnologies evaluated the analytical performance of the Stago sthemO 301 automated system for the hemostasis test panel. The work focused on specific reagents, from the same brand, and followed CLSI guidelines to test:

• limit of detection (LoD);
• the limit of quantification (LoQ);
• linearity of the method;
• analysis on a single site.

Effectiveness of the sthemO 301 analyzer for thrombophilia testing

The study demonstrates good performance of the sthemO AT L, sthemO PS clot, sthemO Free PS L, sthemO PC chrom and sthemO PC clot M tests on the sthemO 301 analyzer. Quantitative measurement of coagulation inhibitors in human citrated plasma proves effective, thus validating the ability of the tests on the machine to assess the risks of thrombophilia.

Once the screening and confirmation tests for the presence of LA/APA are available, our laboratory will be able to complete the validation of the panel for thrombophilia.