title: Technical evaluation of the novel preanalytical module on instrumentation laboratory ACL TOP: advancing automation in hemostasis testing.
abstract: Automation in hemostasis testing is entering an exciting and unprecedented phase. This study was planned to assess the performance of the new preanalytical module on the hemostasis testing system Instrumentation Laboratory ACL TOP. The evaluation included interference studies to define reliable thresholds for rejecting samples with significant concentrations of interfering substances; within-run imprecision studies of plasma indices on four different interference degrees for each index; comparison studies with reference measures of hemolysis index, bilirubin, and triglycerides on clinical chemistry analyzers; and calculation of turnaround time with and without automatic performance of preanalytical check. The upper limits for sample rejection according to our interference studies were 3.6 g/L for hemoglobin, 13.6 mg/dL for bilirubin, and 1454 mg/dL for triglycerides. We found optimal precision for all indices (0.6% to 3.1% at clinically relevant thresholds) and highly significant correlations with reference measures on clinical chemistry analyzers (from 0.985 to 0.998). The limited increase of turnaround time (i.e., +3% and +5% with or without cap-piercing), coupled with no adjunctive costs over performance of normal coagulation assays, contribute to make the automatic check of plasma indices on ACL TOP a reliable and practical approach for improving testing quality and safeguarding patient safety.
authors.affiliation: 1Laboratory of Clinical Chemistry and Hematology, Department of Laboratory Medicine, Academic Hospital of Parma, Parma, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
authors.forename: Luigi
authors.initials: L
authors.lastname: Ippolito
authors.forename: Emmanuel J
authors.initials: EJ
authors.lastname: Favaloro
mesh_terms: D057205:Automation, Laboratory / Q000379:methods*; D001780:Blood Coagulation Tests / Q000379:methods*; D006801:Humans; D010949:Plasma / Q000737:chemistry; D015203:Reproducibility of Results; D012107:Research Design; D013048:Specimen Handling / Q000379:methods*
keywords: automation; interference; preanalytical variability; quality