title: Evaluation of the Q analyzer, a new cap-piercing fully automated coagulometer with clotting, chromogenic, and immunoturbidometric capability.
abstract: The Q analyzer is a recently launched fully automated photo-optical analyzer equipped with primary tube cap-piercing and capable of clotting, chromogenic, and immunoturbidometric tests. The purpose of the present study was to evaluate the performance characteristics of the Q analyzer with reagents from the instrument manufacturer. We assessed precision and throughput when performing coagulation screening tests, prothrombin time (PT)/international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen assay by Clauss assay. We compared results with established reagent instrument combinations in widespread use. Precision of PT/INR and APTT was acceptable as indicated by total precision of around 3%. The time to first result was 3  min for an INR and 5  min for PT/APTT. The system produced 115 completed samples per hour when processing only INRs and 60 samples (120 results) per hour for PT/APTT combined. The sensitivity of the DG-APTT Synth/Q method to mild deficiency of factor VIII (FVIII), IX, and XI was excellent (as indicated by APTTs being prolonged above the upper limit of the reference range). The Q analyzer was associated with high precision, acceptable throughput, and good reliability. When used in combination with DG-PT reagent and manufacturer's instrument-specific international sensitivity index, the INRs obtained were accurate. The Q analyzer with DG-APTT Synth reagent demonstrated good sensitivity to isolated mild deficiency of FVIII, IX, and XI and had the advantage of relative insensitivity to mild FXII deficiency. Taken together, our data indicate that the Q hemostasis analyzer was suitable for routine use in combination with the reagents evaluated.
authors.affiliation: Department of Coagulation, Royal Hallamshire Hospital, Glossop Road, Sheffield, UK. steve.kitchen@sth.nhs.uk
authors.forename: Steve
authors.initials: S
authors.lastname: Kitchen
authors.forename: Anita
authors.initials: A
authors.lastname: Woolley
mesh_terms: D000925:Anticoagulants / Q000494:pharmacology; D001331:Automation; D001777:Blood Coagulation / Q000187:drug effects; D001778:Blood Coagulation Disorders / Q000097:blood / Q000175:diagnosis; D001780:Blood Coagulation Tests / Q000295:instrumentation*; D002863:Chromogenic Compounds; D020147:Coagulation Protein Disorders / Q000097:blood / Q000175:diagnosis; D003124:Colorimetry / Q000295:instrumentation / Q000379:methods; D016903:Drug Monitoring / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D005340:Fibrinogen / Q000032:analysis; D006493:Heparin / Q000494:pharmacology; D057166:High-Throughput Screening Assays / Q000295:instrumentation; D006801:Humans; D007202:Indicators and Reagents; D019934:International Normalized Ratio / Q000295:instrumentation; D009391:Nephelometry and Turbidimetry / Q000295:instrumentation / Q000379:methods; D010314:Partial Thromboplastin Time / Q000295:instrumentation; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014859:Warfarin / Q000494:pharmacology
chemical_list: D000925:Anticoagulants; D002863:Chromogenic Compounds; D007202:Indicators and Reagents; D014859:Warfarin; D005340:Fibrinogen; D006493:Heparin