Performance Evaluation of an Improved ARCHITECT LH Assay for the Quantitative Determination of Luteinizing Hormone in Human Serum and Plasma

Determination of the concentration of human luteinizing hormone plays an important role for the prediction of ovulation, evaluation of infertility, diagnosis of pituitary and gonadal disorders and in the differential diagnosis of puberty disorders. The ARCHITECT LH chemiluminescent-immunoassay for the quantitative determination of luteinizing hormone in human serum and plasma serves this clinical utility. The assay was re-designed to improve robustness in terms of better lot-to-lot consistency, allowing users to discontinue current practice of matching reagent, calibrators and controls. The redesigned ARCHITECT LH assay was evaluated on the ARCHITECT instrument-platform and compared to the predicate device: the previously marketed ARCHITECT LH assay. Total imprecision of the assay was 2.4 8.9%CV across the claimed measuring interval (0.09 250.00 mIU/mL). Detection Limits were determined as Limit of Quantitation with 0.09 mIU/mL, Limit of Blank 0.01 mIU/mL and Limit of Detection 0.03 mIU/mL. Correlation slope to the predicate ARCHITECT LH assay was 1.04. Linearity was demonstrated in the claimed measuring interval. Mean recovery was determined to be 101.0 %. Process capability indices demonstrated excellent (>6 Sigma) lot-to-lot reproducibility. The re-designed ARCHITECT LH assay showed excellent performance and good correlation to the predicate device. The high lot-to-lot reproducibility demonstrates excellent process capability and allows more flexibility in managing inventory for end-users. Matching of reagents, calibrators and controls is no longer required. The ARCHITECT LH assay is a valuable tool in clinical laboratories for the accurate and precise quantitation of human luteinizing hormone.