| Autor: |
Calmette L; Laboratoire d'hématologie, CHU Cochin, Paris, France, UMR-S 1140, Université Paris Descartes, Sorbonne Paris Cité, France., Charpentier N; HYPHEN BioMed, Neuville-sur-Oise, France., Tircot C; HYPHEN BioMed, Neuville-sur-Oise, France., Bigot D; HYPHEN BioMed, Neuville-sur-Oise, France., Dunois C; HYPHEN BioMed, Neuville-sur-Oise, France., Amiral J; HYPHEN BioMed, Neuville-sur-Oise, France., Tetegan M; Laboratoire d'hématologie, CHI Poissy-Saint-Germain-en-Laye, Poissy, France., Sep Hieng S; Laboratoire d'hématologie, CHI Poissy-Saint-Germain-en-Laye, Poissy, France., Peltier JY; Laboratoire d'hématologie, CHI Poissy-Saint-Germain-en-Laye, Poissy, France. |
| Abstrakt: |
Our study aimed to evaluate and validate according to standard NF EN ISO 15189 the original protocol ajustement of Hemoclot Protein C (PC) (Hyphen BioMed), clotting-based assay of PC on ACL TOP analyzer (Werfen/Instrumentation Laboratory). We evaluated the performance in terms of imprecision and we validate additional parameters in range B required by the SH GTA 04 (COFRAC): repeatability, reproducibility, detection and quantification limits, limits of linearity, stability, inter-samples and inter-reagents contamination, inaccuracy, evaluation of interferences (hemolysis, bilirubinemia and chyles). A comparison with Hemoclot PC on STA Compact analyzer (Stago) was performed. Coefficients of variation were lower than 5 %. Detection and quantification limits were respectively 8.3 % and 9.3 %. Superior limit of linearity was 140 %. The test didn't diplay any inter-samples and inter-reagents contamination. Reagent after reconstitution was stable 6 hours on ACL TOP. No interferences were observed for hemoglobin lower than 500 mg/dL, for bilirubin lower than and for chyles lower than 300 mg/dL. Comparison with Hemoclot PC on STA analyzer (Stago) was satisfactory. Hemoclot PC adjusted on ACL TOP analyzer showed satisfactory analytical performances with criteria chosen in our study. These data allow a better knowledge of the performances of this test and were useful to make a validation file in range B as recommended by SH GTA 04. |
