Quantitative automated human chorionic gonadotropin measurement in urine using the Modular Analytics E170 module (Roche)
AbstractOngoing demands on laboratory performance require optimization of processes. An obvious way to achieve this is to reduce manual labor in favor of automated methods. We describe the validation of an automated quantitative urine human chorionic gonadotropin (hCG) analysis on the Roche Modular E170 analyzer to replace the manual qualitative pregnancy test in urine. At urine hCG concentrations of 476, 45 and 11U/L, we found inter-assay variation of 4.3%, 4.3% and 6.8% and average intra-assay variation of 3.0%, 2.6% and 3.0%, respectively. The analytical detection limit was 0.7U/L. We did not detect any loss (due to degradation or adsorption) during a storage period of 5days at 4°C or at −20°C. Recoveries of hCG in urine of a pregnant woman diluted with urine of a pre-menopausal non-pregnant woman (concentration range between 6 and 800mU/L) were between 93% and 112% (y=0.997x−3.843, r