Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer:: A validation study of the CellSearch system
Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer:: A validation study of the CellSearch system
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DOI：
10.1158/1078-0432.ccr-06-1695
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发表时间：
2007-02-01
影响因子：
11.5
通讯作者：
Pantel, Klaus
中科院分区：
文献类型：
--
作者：
Riethdorf, Sabine;Fritsche, Herbert;Pantel, Klaus
目的：Cell Search系统（Veridex，Warren，NJ）旨在富集和计数外周血中的循环肿瘤细胞（CTC）。在这里，我们验证了该系统的分析性能，临床使用的患者转移性breast cancer.Experimental Design：这一前瞻性多中心研究在三个独立的实验室进行的样本92例转移性乳腺癌。使用含有规定数量细胞的质控品的试验内和试验间变异性（平均值分别为50和1，000）、基于不同储存和运输条件的细胞稳定性、掺入4至12个肿瘤细胞的样品的回收精度、仪器间变异性和转移性乳腺癌患者样品的阳性率。两个研究中心的试验内和试验间精密度较高：在同一运行中分析的所有8个阳性对照品和>95%的运行间对照值（n = 299）均在规定范围内。加标样品的平均回收率在80%-82%之间。在70%的转移性乳腺癌患者中检测到CTC。在抽血后立即处理或在室温或4 ℃下储存24、48或72 h后处理的相同样品的CTC值没有显著差异。样品的运输对CTC值没有影响。当分析相同的样品在不同的中心，仪器之间的一致性high.Conclusions：CellSearch系统能够可靠地检测血液中的CTC，是适合于转移性乳腺癌患者在临床实验室的常规评估。血液样本应在室温下运输，CTC计数应稳定至少72 h。
Purpose: The Cell Search system (Veridex, Warren, NJ) is designed to enrich and enumerate circulating tumor cells (CTCs) from peripheral blood. Here, we validated the analytic performance of this system for clinical use in patients with metastatic breast cancer.Experimental Design: This prospective multicenter study conducted at three independent laboratories involved samples from 92 patients with metastatic breast cancer. Intra- and inter-assay variability using controls containing defined numbers of cells (average, 50 and 1,000, respectively), cell stability based on varying storage and shipment conditions, recovery precision from samples spiked with 4 to 12 tumor cells, inter-instrument variability, and positivity of samples from metastatic breast cancer patients were tested.Results: Intra- and inter-assay precision for two sites were high: All eight positive controls analyzed in the same run and >95% of the run to run control values (n = 299) were within the specified ranges. Recovery rate of spiked samples averaged between 80% and 82%. CTCs were detected in similar to 70% of metastatic breast cancer patients. CTC values of identical samples processed either immediately after blood drawing or after storage for 24, 48, or 72 h at room temperature or at 4 degrees C did not differ significantly. Shipment of samples had no influence on CTC values. When analyzing identical samples in different centers, inter-instrument accordance was high.Conclusions: The CellSearch system enables the reliable detection of CTCs in blood and is suitable for the routine assessment of metastatic breast cancer patients in the clinical laboratory. Blood samples should be shipped at room temperature and CTC counts are stable for at least 72 h.