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

Abstract

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 redesigned 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 redesigned 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.

The Effect of Electromagnetic Radiation (Emr) From Laptop on Reproductive Hormones, Sperm Quality and Prostate Specific Antigen of Male Albino Rats (Rattus Norvegicus)

“…65µL of anti-α LH was added to the resulting solution. 145µL of hydrogen peroxide and 165µL of sodium hydroxide was then added to the reaction mixture; the resulting chemiluminescent reaction was measured as relative light units (RLUs) (Oer et al, 2012). A direct relationship exists between the amount of LH in the sample (measured in mIU/mL) and the relative light units detected by the architect optical system.…”

“…A direct relationship exists between the amount of LH in the sample (measured in mIU/mL) and the relative light units detected by the architect optical system. E.g if chemiluminescent reaction measures sample as 3 R.L.Us, it will be calculated as 3R.L.Us = LH (miu/ml), LH (miu/ml) = 1/3.R.L.U; LH = 0.3min/ml (Oer et al, 2012).…”