[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].
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 assay 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.
Products Management Department, International Reagents Corporation, Kobe 651-0083.
Kouki
K
Ito
Hideo
H
Wada
Yasunori
Y
Abe
Hiroaki
H
Tomatsu
Junji
J
Nishioka
Tsutomu
T
Nobori
D000911:Antibodies, Monoclonal; D015415:Biomarkers / Q000097:blood; D004211:Disseminated Intravascular Coagulation / Q000097:blood / Q000175:diagnosis*; D005069:Evaluation Studies as Topic; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis* / Q000276:immunology; D006801:Humans; D007841:Latex Fixation Tests / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012015:Reference Standards
D000911:Antibodies, Monoclonal; D015415:Biomarkers; D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic