Multicentric evaluation of a new assay for prothrombin fragment F1+2 determination.
A multicenter study of a recently developed ELISA for the determination of prothrombin fragment F1+2 was performed in order to evaluate analytical and clinical aspects. Mean intra-assay and inter-assay reproducibility were found to be 11.0 and 12.6%, respectively. The measuring range covered by the calibration curve reaches from 0.04 to 10.0 nM/l F1+2. Testing 133 healthy subjects a reference range of 0.37 to 1.11 nM/l F1+2 (2.5-97.5 percentile) with a median of 0.66 nM/l F1+2 was calculated. Minor difficulties with blood sampling (venous occlusion for 2 min) did not affect F1+2 plasma concentrations. Significantly increased F1+2 levels were measured in patients with leukemia (p < 0.0001), severe liver disease (p < 0.005) and after myocardial infarction (p < 0.01). Elevated F1+2 concentration before the beginning of heparin therapy (1.25 nM/l) decreased to 0.77 nM/l (p < 0.0001) after 1 day of therapy. For patients in the stable phase of oral anticoagulant therapy decreasing F1+2 concentrations were measured with increasing INR. F1+2 levels were already significantly reduced in patients with INR < 2.0 (0.56 nM/l; p = 0.0005). Thus F1+2 determination may be helpful in identifying activation processes as well as in monitoring anticoagulant therapy.
Bruhn
H D
HD
Medizinische Klinik, Kiel, FRG.
Conard
J
J
Mannucci
M
M
Monteagudo
J
J
Pelzer
H
H
Reverter
J C
JC
Samama
M
M
Tripodi
A
A
Wagner
C
C
D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D001778:Blood Coagulation Disorders / Q000097:blood* / Q000188:drug therapy; D004797:Enzyme-Linked Immunosorbent Assay; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008104:Liver Cirrhosis, Alcoholic / Q000097:blood; D008232:Lymphoproliferative Disorders / Q000097:blood; D010446:Peptide Fragments / Q000032:analysis*; D011516:Prothrombin / Q000032:analysis*; D012016:Reference Values; D015203:Reproducibility of Results
D000925:Anticoagulants; D015415:Biomarkers; D005343:Fibrinolytic Agents; D010446:Peptide Fragments; C045879:prothrombin fragment 1.2; D011516:Prothrombin; D006493:Heparin