title: Analytical performances of Hemoclot Protein C Reagent on ACL TOP analyzer.
abstract: 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.
authors.affiliation: Laboratoire d'hématologie, CHU Cochin, Paris, France, UMR-S 1140, Université Paris Descartes, Sorbonne Paris Cité, France.
authors.forename: Leyla
authors.initials: L
authors.lastname: Calmette
authors.affiliation: HYPHEN BioMed, Neuville-sur-Oise, France.
authors.forename: Nicole
authors.initials: N
authors.lastname: Charpentier
authors.affiliation: HYPHEN BioMed, Neuville-sur-Oise, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Tircot
authors.affiliation: HYPHEN BioMed, Neuville-sur-Oise, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Bigot
authors.affiliation: HYPHEN BioMed, Neuville-sur-Oise, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Dunois
authors.affiliation: HYPHEN BioMed, Neuville-sur-Oise, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Amiral
authors.affiliation: Laboratoire d'hématologie, CHI Poissy-Saint-Germain-en-Laye, Poissy, France.
authors.forename: Marcelle
authors.initials: M
authors.lastname: Tetegan
authors.affiliation: Laboratoire d'hématologie, CHI Poissy-Saint-Germain-en-Laye, Poissy, France.
authors.forename: Sonnthida
authors.initials: S
authors.lastname: Sep Hieng
authors.affiliation: Laboratoire d'hématologie, CHI Poissy-Saint-Germain-en-Laye, Poissy, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Peltier
mesh_terms: D000068:Accreditation; D016477:Artifacts; D057205:Automation, Laboratory / Q000295:instrumentation*; D001778:Blood Coagulation Disorders / Q000097:blood / Q000175:diagnosis; D001780:Blood Coagulation Tests / Q000295:instrumentation / Q000379:methods / Q000592:standards; D003951:Diagnostic Errors; D004355:Drug Stability; D004866:Equipment Contamination; D006801:Humans; D011486:Protein C / Q000032:analysis*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000379:methods
chemical_list: D011486:Protein C; D011933:Reagent Kits, Diagnostic
keywords: ACL TOP; COFRAC; Hemoclot protein C; NF EN 15189; clotting-based protein C; protein C; range B analytical validation