Summary
Hypofibrinolysis is a risk factor for venous and arterial thrombosis, and can be assessed
by using a turbidimetric tPA-induced clot lysis time (CLT) assay. Biological variation
in clot lysis time may affect the interpretation and usefulness of CLT as a risk factor
for thrombosis. Sufficient information about assay variation and biological variation
in CLT is not yet available. Thus, this study aimed to determine the analytical, within-subject
and between-subject variation in CLT. We collected blood samples from 40 healthy individuals
throughout a period of one year (average 11.8 visits) and determined the CLT of each
plasma sample in duplicate. The mean (± SD) CLT was 83.8 (± 11.1) minutes. The coefficients
of variation for total variation, analytical variation, within-subject variation and
between-subject variation were 13.4%, 2.6%, 8.2% and 10.2%, respectively. One measurement
can estimate the CLT that does not deviate more than 20% from its true value. The
contribution of analytical variation to the within-subject variation was 5.0%, the
index of individuality was 0.84 and the reference change value was 23.8%. The CLT
was longer in the morning compared to the afternoon and was slightly longer in older
individuals (> 40 years) compared to younger (≤40 years) individuals. There was no
seasonal variation in CLT and no association with air pollution. CLT correlated weakly
with fibrinogen, C-reactive protein, prothrombin time and thrombin generation. This
study provides insight into the biological variation of CLT, which can be used in
future studies testing CLT as a potential risk factor for thrombosis.
Keywords
CLT - biological variation - fibrinolysis