PB0132 - Determination and verification of reference intervals on the new Stago coagulation analyzer sthemO 301

Background: The sthemO 301 is a new fully automated coagulation analyzer developed by Diagnostica Stago (Asnières, France), designed for in vitro diagnosis use, performing clotting, chromogenic and immunoassay methods.

Aims: These studies’ aim was to determine or verify reference intervals (RI) in healthy donors for the following coagulation factors (F): FII, FV, FVII, FVIII, FIX and FX.

Methods: Inclusion criteria were healthy donors (both men and women) between 18 to 65 years old, not having any pathology nor taking drugs affecting blood coagulation. Blood collection was approved by the Maastricht University Medical Center’s medical ethical committee and performed after obtaining written informed consent. The blood, collected in 3.2% citrated tubes, was double centrifuged within two hours for preparation of platelet poor plasma. Only frozen (-70°C) samples were tested. Verification of a published RI required a minimum of 20 samples with no outliers whereas RI determination required a minimum of 120 samples, according to Clinical Laboratory Standard Institute (CLSI) EP28-A3c. Quality Controls (QCs) were tested at the beginning and at the end of each run during sample testing to validate the runs.

Results: RI results for verification study (number of samples, minimum and maximum age of donors) are presented in Table 1. RI results for determination studies are presented in Table 2. QCs standard deviations and/or coefficient of variations were all within the acceptance criteria according to the French Group of Hemostasis and Thrombosis Study (Propositions du groupe de travail du GEHT, « Normes d’Acceptabilité en Hémostase ». August 2014).

Conclusion(s): These RI values determined for the aforementioned coagulation assays will provide an aid to the laboratories during the RIs local verification at system implementation on the sthemO 301 analyzer.