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The Korean Association of Immunobiologists (대한면역학회)
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Meaning of the DR-$70^{TM}$ Immunoassay for Patients with the Malignant Tumor

악성 종양 환자에 대한 DR-$70^{TM}$ 면역 분석법의 의의: Validation Study

  • Lee, Ki-Ho (Yonsei University, Research Institute of Aging Science) ;
  • Cho, Dong-Hee (Department of Laboratory Medicine, Sungkyunkwan University School of Medicine, Samsung Cheil Hospital) ;
  • Kim, Sang-Man (Pochon Cha University Cha Bio Medical Center) ;
  • Lee, Duck-Joo (Pochon Cha University Cha Bio Medical Center) ;
  • Kim, Kwang-Min (Department of Family Medicine, Ajou University)
  • 이기호 (연세대학교 노화과학연구소) ;
  • 조동희 (성균관대학교 의과대학 삼성제일병원 진단검사의학과) ;
  • 김상만 (포천중문의과대학교 강남차병원 차바이오 메디컬센터) ;
  • 이득주 (포천중문의과대학교 강남차병원 차바이오 메디컬센터) ;
  • 김광민 (아주대학교병원 가정의학과 종합검진센터)
  • Published : 2006.03.30
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Abstract

Background: The DR-$70^{TM}$ immunoassay is a newly developed cancer diagnostic test which quantifies the serum fibrin degradation products (FDP), produced during fibrinolysis, by antibody reaction. The purpose of this study was to evaluate the potential of DR-$70^{TM}$ Immunoassay in screening malignant tumor. Methods: Sample subjects were 4,169 adults, both male and female, who visited the health promotion center of a general hospital from March 2004 to April 2005 and underwent the DR-$70^{TM}$ immunoassay test and other tests for cancer diagnosis. The patient group was defined as 42 adults out of the sample subjects who were newly diagnosed with cancer during the same time period when the DR-$70^{TM}$ immunoassay test was performed. Final confirmation of a malignant tumor was made by pathological analysis. Results: The mean DR-$70^{TM}$ level was $0.83{\pm}0.65{\mu}g/ml$ (range: 0.00 (0.0001)${\sim}7.42{\mu}g/ml)$ in the control group (n=4,127) as opposed to $2.70{\pm}2.33{\mu}g/ml$ (range: $0.12{\sim}9.30{\mu}g/ml)$ in the cancer group (n=42), and statistical significance was established (p<0.0001, Student t-test). When categorized by the type of malignant tumor, all cancer patients with the exception of the subgroups of colon and rectal cancer showed significantly higher mean DR-$70^{TM}$ levels compared with the control group (p<0.0001, Kruscal-Wallis test). The receiver operating characteristic (ROC) curve analysis revealed ${\geq}1.091{\mu}g/ml$ as the best cut-off value. Using this cut-off value, the DR-$70^{TM}$ immunoassay produced a sensitivity of 71.4%, a specificity of 70.1%, a positive predictability of 69.4%, and a negative predictability of 69.2% (1). Conclusion: A significant increase in the mean DR-$70^{TM}$ value was observed in the cancer group (thyroidal, gastric, breast, hepatic and ovarian) com pared with the control group. In particular, the specificity and sensitivity of the DR-$70^{TM}$ immunoassay was relatively high in the subgroups of breast, gastric, and thyroidal cancer patients. There is need for further studies on a large number of malignant tumor patients to see how the DR-$70^{TM}$ level might be changed according to the differentiation grade and postoperative prognosis of the malignant tumor.

Keywords

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