抗 FDP モノクローナル抗体を用いた
血漿中 FDP 測定試薬の評価：
DIC 診断基準への適用に関する検討
伊 藤 幸 紀*1 和 田 英 夫*2 阿 部 泰 典*3
戸 松 宏 明*4 西 岡 淳 二*5 登 勉*6
Clinical Evaluation of a Test for Plasma Fibrin/Fibrinogen Degradation Products(FDP)
Based on Monoclonal anti-FDP Antibody Technology：An Application for the Scoring System
of the Disseminated Intravascular Coagulation(DIC) Diagnostic Criteria
Kouki ITO*1, Hideo WADA, MD*2, Yasunori ABE*3,
Hiroaki TOMATSU*4, Junji NISHIOKA*5 and Tsutomu NOBORI, MD*6
Fibrin/fibrinogen degradation products(FDP) have been measured using serum
samples which were specially prepared for the FDP test because of the usage
of anti-human fibrinogen antibody for the assay. Since diagnostic criteria
for DIC were established by the study group on thrombosis and hemostasis
which is supported by the Japanese Ministry of Health and Welfare(JMHW),
serum FDP assays have been used as standard methods to diagnose DIC in
Japan.
Recently, a reagent using an anti-human FDP monoclonal antibody was developed and this has enabled the use of plasma samples for FDP measurement. The comparability, especially of the DIC score, of a new assay, Latex test BL-2 P-FDP, using plasma samples with a conventional assay for serum was investigated. Two sets of DIC scores based on data from the two tests were compared and the correlation was high with 97.5% of the patients being diagnosed with the same DIC status.
In four disease groups−DIC, thrombosis, leukemia and solid cancer−high comparability between the two tests was also shown and no significant difference was observed in the correlation coefficient and the slope coefficient between serum and plasma samples.
To conclude, it is suggested that "Latex test BL-2 P-FDP" is applicable to the diagnostic criteria for DIC from JMHW without any difficulty.
[Rinsho Byori 51 : 295〜299, 2003]
*1Products Management Department, International Reagents Corporation, Kobe 651-0083
【Key Words】fibrin/fibrinogen degradation products：FDP(フィブリンおよびフィブリノゲン分解産物)，anti-human FDP monoclonal antibody(抗ヒト FDP モノクローナル抗体)，diagnostic criteria for DIC(DIC 診断基準)
受付2002年2月27日・受理2003年2月13日
*1国際試薬株式会社学術部(〒651-0083 神戸市中央区浜辺通2-1-30)
*3〜5三重大学医学部附属病院中央検査部，*2,6同 臨床検査医学講座(〒514-8507津市江戸橋2-174)