Variability in a commercially available enzyme-linked immunosorbent assay system. II. Laboratory variability.

An experiment was conducted to determine the amount of variability that occurred in enzyme-linked immunosorbent assays when samples from common serum pools were assayed in five different labs on three consecutive days. Low- (approximately 1:2000), medium- (approximately 1:4000), and high-titered (approximately 1:8000) serum pools were distributed to five poultry industry laboratories that cooperated in the study. Results varied significantly among different laboratories and among different days in the same lab. Variation among days within the same laboratory and among laboratories were large. The greatest variability occurred among labs. Correlations between mean daily titer and laboratory ambient temperature were small and not significant. The amount of variability within and among different laboratories that were observed indicate that single determinations on individual serum samples are not likely to give a reliable estimate of antibody titer. The large variability within labs further indicates the need for standard reference pools of positive serum to be included in assays in order to substantiate assay results.