Riethdorf Sabine, Fritsche Herbert, Müller Volkmar, Rau Thomas, Schindlbeck Christian, Rack Brigitte, Janni Wolfgang, Coith Cornelia, Beck Katrin, Jänicke Fritz, Jackson Summer, Gornet Terrie, Cristofanilli Massimo, Pantel Klaus
Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Clin Cancer Res. 2007 Feb 1;13(3):920-8. doi: 10.1158/1078-0432.CCR-06-1695.
The CellSearch 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.
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.
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 approximately 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.
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.
CellSearch系统（Veridex公司，新泽西州沃伦）旨在从外周血中富集并计数循环肿瘤细胞（CTC）。在此，我们验证了该系统在转移性乳腺癌患者临床应用中的分析性能。
这项前瞻性多中心研究在三个独立实验室进行，纳入了92例转移性乳腺癌患者的样本。使用含有特定数量细胞（平均分别为50和1000个）的对照进行批内和批间变异分析，基于不同储存和运输条件检测细胞稳定性，检测加入4至12个肿瘤细胞的样本的回收精密度，分析仪器间变异，以及检测转移性乳腺癌患者样本的阳性率。
两个检测点的批内和批间精密度均较高：同一次运行中分析的所有8个阳性对照以及超过95%的批次间对照值（n = 299）均在指定范围内。加标样本的回收率平均在80%至82%之间。约70%的转移性乳腺癌患者检测到CTC。采血后立即处理或在室温或4℃下储存24、48或72小时后处理的相同样本的CTC值无显著差异。样本运输对CTC值无影响。在不同中心分析相同样本时，仪器间一致性较高。
CellSearch系统能够可靠地检测血液中的CTC，适用于临床实验室对转移性乳腺癌患者进行常规评估。血样应在室温下运输，且CTC计数至少72小时稳定。
