We developed a new and automated assay for the detection of lung cance
r associated cytokeratin 19 fragments in patients' sera/plasma. This n
ew tumour marker assay CYFRA 21-1 was evaluated in technical and clini
cal studies using the multibatch analysers ES 300 and ES 600 from Boeh
ringer Mannheim GmbH. The analytical performance was shown to be excel
lent. The clinical data from 2,037 patients demonstrate that for non-s
mall-cell lung carcinoma CYFRA 21-1 has a higher diagnostic sensitivit
y compared to the established markers. Mainly for squamous cell carcin
oma CYFRA 21-1 was superior (60%) to CEA (18%) or SCC (31%).