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Info. Vol.13 - No.4 (2019.12.20)
Title Clinical Studies of Ci-5, Sol-gel Encapsulated Multiplex Antibody Microarray for Quantitative Fluorometric Detection of Simultaneous Five Different Tumor Antigens
Authors Jae Kong Kim1, Hwan-Moon Song1, Jong Woo Jun1, Hyun Ji Park1, Eun-Su Lim1, Kyunghwan Lee1, SangWook Lee1 & Soyoun Kim1,2,*
Institutions 1PCL, Inc, 17th Floor, #B, 128, Beobwon-ro, Songpa-gu, Seoul 05854, Republic of Korea
2Department of Biomedical Engineering, Dongguk University, 30, Pildong-ro 1-gil, Jung-gu, Seoul, 100-715, Republic of Korea
*Correspondence and requests for materials should be addressed to S.Y. Kim (skim@pclchip.com)
Abstract 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 CapTM 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.
Keyword Multiplex immunoassay, Sol-gel capturing, Cancer diagnosis, Clinical trials
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