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Thank you for attending THSNA 2026. The virtual meeting is now closed.
Thank you for attending THSNA 2026. The virtual meeting is now closed.
Presentation Details
| Performance Evaluation, Precision and Method Comparison of a Novel Automated Coagulation Analyzer Gabrielle Pearl, Lisa Meadows, Vickie Simmons, Mary Knighten, LaShanta Brice, Paul Riley. Diagnostica Stago, Inc., Parsippany, NJ, USA |
Abstract
Background: Coagulation instrument performance evaluations, consisting of precision and method comparison studies are needed for a successful diagnostic instrument regulatory submission. A novel automated coagulation analyzer with improved pipetting system, and detection of potential hemolysis, icterus, and lipemic (HIL) was developed, requiring extensive studies to support regulatory submission ahead of commercial launch. The analyzer uses three analytical methods: 1) viscosity-based clotting time measurement 2) chromogenic and 3) immunoturbidometric, allowing for a variety of hemostasis testing application. Regulatory submission requires demonstration of performance of a variety of different coagulation assays employing the different analytical methods. This abstract will highlight the results of the precision and method comparison studies. Objectives: The purpose of this study was to validate the performance of the STA R Max3 for USA regulatory registration by assessing analytical performances of prothrombin time (PT), activated partial thromboplastin time (aPTT), and Fibrinogen for clotting time measurement; antithrombin (AT) activity for chromogenic, and D-Dimer for immunoturbidimetric methodology through comparison to the earlier commercialized version, the STA R Max. Methods: STA Neoplastine CI Plus was used for PT testing, STA PTT A for aPTT, STA Fibrinogen for fibrinogen Clauss assay, STA Stachrom ATIII for AT activity, and STA Liatest D-Di for D-dimer. Precision studies were performed in accordance with Clinical Laboratory Standards Institute (CLSI) guideline EP05-A3 using two levels of QC run as samples. QC material used was STA Coag Control N+P for PT, aPTT, Fib, and AT activity, along with STA Liatest N+P for D-dimer. The multi-site precision study tested the QC samples with two runs per day, in triplicate over a period of five days. The single site precision study was performed using two duplicate QC sample runs per day over a period of twenty days. Analytical performances were assessed by calculating the CV and SD for within-run and within-laboratory results per site. Results from the three sites were combined to calculate CV and SD for repeatability and reproducibility of each assay. The method comparison study was performed in accordance with CLSI EP09c. Approximately one hundred fifty residual samples were analyzed in duplicate for each parameter. Analytical performances were assessed by calculating the slope, intercept, % coefficient of variation (CV) and bias, measured on both the STA R Max3 and STA R Max models. Acceptance criteria were chosen for each parameter tested according to established clinical trial protocols based on CLSI EP09c. Results: The table outlines the results for the PT, aPTT, Fibrinogen, AT, and D-dimer precision studies, highlighting hemostasis tests utilized each methodology. Conclusions: The STA R Max3 showed excellent precision and comparison results within desired acceptance criteria and subsequently received full regulatory clearance. The instrument was subsequently commercialized in the USA in late 2023.
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No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.