Here, we developed Sol-gel based antibody microarray platform for quantitative detection of five different cancer biomarkers in clinical sample simultaneously. This kit called Ci-5, Multiplex Tumor Marker Quantitative Kit, is developed based on proprietary SG Cap™ technology. The Ci-5 has 3×5 format of microarray that contains five different antibodies for capturing multi-targets cancer biomarkers, AFP (Liver cancer), CEA (Colon cancer), PSA (Prostate cancer), CA125 (Ovarian cancer) and CA19-9 (Pancreatic cancer), which are approved by CE (Registration No. HL 60135402 0001). Using the Ci-5 kit, we tested 440 clinical specimens for multiplex detection of five different cancer biomarkers simultaneously. The results show high clinical sensitivity (86.7% for CA19-9, 94.7% for AFP, 97% for CEA, 89.8% for PSA and 69.6% for CA125) and specificity (96.2% for CA19-9, 81.1% for AFP, 92.3% for CEA, 98.4% for PSA and 98.7% for CA125). Additionally, Ci-5 shows strong correlation with state-of-art CLIA methods (R²=0.9282, 0.9718, 0.9847, 0.9707 and 0.9219 for CA19-9, AFP, CEA, PSA and CA125). The highly sensitive and selective multiplex sol-gel microarray platform holds promise for improved accuracy of early cancer stage diagnosis as well as recurrence monitoring of cancer patients. Moreover, Ci-5 is the first approved biochip for tumor marker quantitative detection kit which can be used for both manual and automatic liquid handling system.

中文翻译：

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Ci-5溶胶-凝胶封装的多重抗体芯片用于同时五个不同肿瘤抗原的荧光定量检测的临床研究

在这里，我们开发了基于溶胶凝胶的抗体微阵列平台，用于同时定量检测临床样品中的五种不同的癌症生物标志物。该套件名为Ci-5，即多重肿瘤标记定量套件，是基于专有SG Cap™技术开发的。Ci-5具有3×5格式的微阵列，其中包含五种不同的抗体，可捕获多目标癌症生物标志物，AFP（肝癌），CEA（结肠癌），PSA（前列腺癌），CA125（卵巢癌）和CA19- 9（胰腺癌），这是CE批准的（注册号HL 60135402 0001）。使用Ci-5试剂盒，我们测试了440个临床标本，以便同时对5种不同的癌症生物标记物进行多重检测。结果显示出较高的临床敏感性（CA19-9为86.7％，AFP为94.7％，CEA为97％，PSA为89.8％，CA125为69.6％）和特异性（96。CA19-9为2％，AFP为81.1％，CEA为92.3％，PSA为98.4％，CA125为98.7％）。此外，Ci-5与最新的CLIA方法（R² = 0.9282，0.9718，0.9847，0.9707和0.9219为CA19-9，AFP，CEA，PSA和CA125）。高灵敏度和选择性的多重溶胶-凝胶微阵列平台有望提高癌症早期诊断的准确性以及癌症患者的复发监测。此外，Ci-5是首个获得批准的用于肿瘤标记物定量检测试剂盒的生物芯片，可用于手动和自动液体处理系统。