多项肿瘤标志物生物芯片检测系统的初步临床应用

Preliminary Clinical Application of Bio-chip Detection for Multi-tumor Markers

多项肿瘤标志物生物芯片(C-12芯片)检测系统是利用生物芯片的平行检测能力,一次检测可以获得 AFP、NSE、PSA、fPSA、CEA、CA125、CA242、CA15-3、CA19-9、β-HCG、HGH和铁蛋白共12项指标的含量。本 研究采用C-12芯片进行人群肿瘤筛查2243例,各种恶性肿瘤和非肿瘤病人1836例。根据随访结果分析C-12 芯片检测的临床应用价值。C-12芯片进行人群肿瘤筛查共发现有41人检测结果呈异常(阳性率1．99％),2例 确诊为恶性肿瘤。C-12芯片对检测恶性肿瘤的总阳性率为68．5％(207／302),而对非肿瘤疾病的检测总阳性率 为17．1％(263／1534),提示C-12芯片可用于人群肿瘤初步筛查,在临床上对多种常见肿瘤有较高的辅助临床诊 断价值,但对非肿瘤疾病的检测阳性率偏高。

In order to tesify the clinical validation of a bio-chip system chip-C12, which can simultaneously measure 12 tumor markers.. AFP, CEA, PSA, fPSA, CA125, CA15-3, CA19-9, CA242,NSE,β-HCG, HGH and Ferritin, in the cancer screening and oncological diagnosis, 2243 healthy subjects were screened for cancers and 1836 patients with various suspected cancers or none-cancer diseases were tested by chip-C12. The results showed that for cancer screening, 41 serum samples were found to be positive, with the positive rate of 1.99%, but only two persons of them were subsequently confirmed to have cancers. For clinical utilities, the chip system showed an overall positive rate of 68.5%（207/302） for cancer patients, but for nonecancer patients the positive rate was up to 17. 1% （263/1543）. These data indicated that the bio-chip system may well be a valuable tool for screening cancers. It can also be used in clinic to assist the medical doctors in clinical diagnosis for common cancers. However, for none-cancer diseases, it is connected with a relatively high pseudo positive rate, a problematic issue should be solved in future.