External quality assurance of circulating tumor cell enumeration using the CellSearch® system: A feasibility study

Background: Circulating tumor cells (CTCs) are cells that have detached from solid tumors and entered the blood. CTCs can be detected, among others, by semi‐automated immunomagnetic enrichment and image cytometry using CellSearch® (Veridex, Raritan, NJ). We studied the feasibility of external qualit...

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Veröffentlicht in:Cytometry. Part B, Clinical cytometry Clinical cytometry, 2011-03, Vol.80B (2), p.112-118
Hauptverfasser: Kraan, Jaco, Sleijfer, Stefan, Strijbos, Michiel H., Ignatiadis, Michail, Peeters, Dieter, Pierga, Jean‐Yves, Farace, Francoise, Riethdorf, Sabine, Fehm, Tanja, Zorzino, Laura, Tibbe, Arjan G. J., Maestro, Marisa, Gisbert‐Criado, Rafael, Denton, Graeme, de Bono, Johann S., Dive, Caroline, Foekens, John A., Gratama, Jan W.
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container_end_page 118
container_issue 2
container_start_page 112
container_title Cytometry. Part B, Clinical cytometry
container_volume 80B
creator Kraan, Jaco
Sleijfer, Stefan
Strijbos, Michiel H.
Ignatiadis, Michail
Peeters, Dieter
Pierga, Jean‐Yves
Farace, Francoise
Riethdorf, Sabine
Fehm, Tanja
Zorzino, Laura
Tibbe, Arjan G. J.
Maestro, Marisa
Gisbert‐Criado, Rafael
Denton, Graeme
de Bono, Johann S.
Dive, Caroline
Foekens, John A.
Gratama, Jan W.
description Background: Circulating tumor cells (CTCs) are cells that have detached from solid tumors and entered the blood. CTCs can be detected, among others, by semi‐automated immunomagnetic enrichment and image cytometry using CellSearch® (Veridex, Raritan, NJ). We studied the feasibility of external quality assurance (EQA) of the entire CellSearch procedure from blood draw to interpretation of results in multiple laboratories. Methods: Blood samples from six cancer patients and controls were distributed to 14 independent laboratories to test between‐laboratory, between‐assay, and between‐instrument variation. Additionally, between‐operator variability was assessed through the interpretation of blinded images of all blood samples on a website. Results: Shipment and storage of samples had no influence on CTC values. Between‐instrument (coefficient of variation (CV) < 12%) and between‐assay variation was low (CV ≤ 20%), indicating high reproducibility. However, between‐laboratory CV ranged from 45 to 64%. Although inter‐operator agreement on image interpretation (Fleiss' κ statistics) ranged from “substantial” to “almost perfect,” image interpretation, particularly of samples containing high numbers of apoptotic cells, was the main contributor to between‐laboratory variation. Conclusions: This multicenter study shows the feasibility of an EQA program for CTC detection in patient samples, and the importance of continuation of such a program for the harmonization of CTC enumeration. © 2010 International International Clinical Cytometry Society
doi_str_mv 10.1002/cyto.b.20573
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Methods: Blood samples from six cancer patients and controls were distributed to 14 independent laboratories to test between‐laboratory, between‐assay, and between‐instrument variation. Additionally, between‐operator variability was assessed through the interpretation of blinded images of all blood samples on a website. Results: Shipment and storage of samples had no influence on CTC values. Between‐instrument (coefficient of variation (CV) &lt; 12%) and between‐assay variation was low (CV ≤ 20%), indicating high reproducibility. However, between‐laboratory CV ranged from 45 to 64%. Although inter‐operator agreement on image interpretation (Fleiss' κ statistics) ranged from “substantial” to “almost perfect,” image interpretation, particularly of samples containing high numbers of apoptotic cells, was the main contributor to between‐laboratory variation. 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Although inter‐operator agreement on image interpretation (Fleiss' κ statistics) ranged from “substantial” to “almost perfect,” image interpretation, particularly of samples containing high numbers of apoptotic cells, was the main contributor to between‐laboratory variation. 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subjects Cell Count
circulating tumor cells
external quality assessment
Feasibility Studies
Flow Cytometry - standards
Humans
immunomagnetic enrichment
multicenter study
Neoplasms - blood
Neoplasms - pathology
Neoplastic Cells, Circulating - pathology
Quality Control
rare events
Reproducibility of Results
title External quality assurance of circulating tumor cell enumeration using the CellSearch® system: A feasibility study
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