Centralization of multisite reagent lot-to-lot validation for Ortho Clinical Vitros chemistry instruments.

Objective: Reagent lot-to-lot comparisons are recommended by accreditation bodies to ensure that the performance of each reagent lot meets acceptable standards for quality patient results. The general approach is comprised of performing quality control (QC) and patient comparison between the old and new reagent lots and evaluating against a pre-defined criteria. Reagent lot comparison practices are often variable despite using the same instrument across different laboratories.

Multi-platform analytical evaluation of the Beckman Coulter Access high-sensitivity troponin I assay across different laboratory sites using Barricor plasma.

Objectives: Previous analytical evaluations of the Beckman Coulter Access high sensitivity troponin (hsTn) I assay have focused on single platforms and laboratory sites. The purpose of this study was to determine assay robustness across different platforms at multiple sites, platform-specific characteristics, and equivalence to other hsTn methods in a large laboratory network.

Methods: Barricor plasma was used to assess imprecision, linearity, sensitivity (limit of blank and detection, LOB/LOD), and comparability to the conventional AccuTnI+3 and other hsTn assays.

Analytical Concordance of Diverse Point-of-Care and Central Laboratory Troponin I Assays.

Background: Cardiac troponin I (cTnI) 99th percentile cutoffs, used in the diagnosis of acute myocardial infarction, are not standardized across cTnI assays. We compared 3 point-of-care (POC) and 1 central laboratory contemporary cTnI assays against the Abbott high-sensitivity (hs) cTnI to evaluate the analytical concordance and the feasibility of using a single cutoff value for all assays.

Methods: Fresh blood samples collected from 102 inpatients in the coronary care unit were measured on central laboratory instruments (Beckman Coulter DxI AccuTnI+3 TnI, Abbott Architect hs-TnI) and cTnI POC analyzers (Alere Triage Troponin I, Radiometer AQT90, Abbott i-STAT).

Barricor blood collection tubes are equivalent to PST for a variety of chemistry and immunoassay analytes except for lactate dehydrogenase.

Introduction: The BD Barricor tube uses a novel mechanical separator designed to eliminate gel artifacts, decrease cellular contamination, and improve stability. Here, we evaluated the Barricor tube as a possible replacement for PST using Beckman Coulter analyzers under both optimal, alternative, and suboptimal centrifugation conditions based on BD recommendations.

Methods: Paired PST and Barricor samples were collected from 4 local hospitals and processed based on site-specific preanalytical systems involving automated or manual centrifugation.

Analytical evaluation of the Radiometer AQT90 FLEX βhCG assay.

Objectives: Many hospitals cannot afford an hCG assay on a central lab analyzer and turn to point of care testing (POCT) solutions. The Radiometer AQT90 FLEX is a small benchtop immunoareement between the AQT90 and comparator methods for samples with hCG ssay analyzer for use in the laboratory or at the patient bedside. This study evaluated the analytical performance of the AQT90's βhCG assay.

The BD Barricor blood collection tube is an acceptable and robust alternative to the PST for use with the Beckman AccuTnI+3 assay.

Objectives: BD Canada recently released a blood collection tube with a novel mechanical separator called the Barricor. We evaluated this tube as an alternate sample type for cardiac troponin I (cTnI) testing using the Beckman Coulter AccuTnI+3 assay.

Design And Methods: 3014 paired patient specimens (Barricor, plasma separator tube or PST) were obtained from the emergency departments and cardiac care units of nine hospitals in and around Edmonton, Alberta.