ICSH guidelines for the verification and performance of automated cell counters for body fluids

Abstract

Summary One of the many challenges facing laboratories is the verification of their automated Complete Blood Count cell counters for the enumeration of body fluids. These analyzers offer improved accuracy, precision, and efficiency in performing the enumeration of cells compared with manual methods. A patterns of practice survey was distributed to laboratories that participate in proficiency testing in Ontario, Canada, the United States, the United Kingdom, and Japan to determine the number of laboratories that are testing body fluids on automated analyzers and the performance specifications that were performed. Based on the results of this questionnaire, an International Working Group for the Verification and Performance of Automated Cell Counters for Body Fluids was formed by the International Council for Standardization in Hematology (ICSH) to prepare a set of guidelines to help laboratories plan and execute the verification of their automated cell counters to provide accurate and reliable results for automated body fluid counts. These guidelines were discussed at the ICSH General Assemblies and reviewed by an international panel of experts to achieve further consensus.

Reflex Testing Rules for Cell Count and Differentiation of Nucleated Elements in Pleural and Ascitic Fluids on Sysmex XE-5000

“…26 The WBC-DIFF scattergrams, with clearly defined clusters, allow a reliable quantitative analysis of leukocyte population, especially polymorphonuclear leukocytes and NEs, but not mononuclear cells. 1 Even more importantly, the definition of validation rules and related reflex tests for automated cell counting has contributed to further improve the diagnostic performance of this analyzer.…”

Evaluation of Mindray BC-6800 body fluid mode for automated cerebrospinal fluid cell counting

“…Samples were analyzed according to CLSI document H56-A, in 2006 [7] and the ICSH guidelines, in 2014 [31,32] as described below. In order to ensure the standardization of the procedure for manual counting, appropriate materials were used such as certified pipettes and cleaned chambers.…”

“…According to the ICSH guidelines, in 2014 [31,32] and CLSI document H20-A2, in 2010 [33], a differential count was performed on 200 cells in each sample by two experienced examiners and by a third person if the first two results showed about a 5% disagreement; a 400 × magnification was used.…”

“…The aim of this study was to evaluate BC-6800-BF mode counting performances on CSF, according to CLSI document H56-A, in 2006 [7] and ICSH guidelines for the verification and performance of automated cell counters for body fluids, in 2014 [31].…”

Comparison between optical microscopy and automation for cytometric analysis of pericardial fluids in a cohort of adult subjects undergoing cardiac surgery

“…All published studies aimed at exploring the cellular composition of PF have some limitations. These basically include the limited sample size, the poor clinical characterisation of the patients, methodological drawbacks (both analytical and statistical), but are also plagued by inaccurate application of current guidelines for analysis of body fluids, such as those issued by the Clinical and Laboratory Standard Institute (CLSI document H56-A)18 or by the International Council for Standardization in Haematology (ICSH) 19…”