Basic study of ‘STACIA MEBLuxTM TEST mitochondria M2’, a reagent for anti-mitochondrial antibody measurement

Abstract

We performed basic evaluation studies of ‘STACIA MEBLuxTM TEST mitochondria M2’ (STACIA), a reagent for anti-mitochondrial M2 antibody measurement by chemiluminescent enzyme immunoassay. Results showed that the CVs of within-run and between-day precisions were less than 6.0%. No effects from interfering substances (bilirubin F, bilirubin C, hemoglobin and chyle) were detected. However, the rheumatoid factor showed negative effects. In addition, the correlation of STACIA with ‘Elia mitochondria M2’ (ELIa), a comparison product, was good (y = 0.815x + 0.691, r = 0.830, n = 184). The correlation between STACIA (< Index 7.0) and ELIa was shown by the correlation factor r = 0.482 and the regression equation y = 0.071x + 0.929 (n = 128). Nineteen samples were positive for the antibody in the measurement using ELIa and nineteen samples were negative in the measurement using STACIA. Positive and negative concordance rates were good (81.5%). However, the positive concordance rate (73.2%) was lower than the negative concordance rate (98.0%). STACIA showed basic performance good enough for routine use. However, the interpretation of the data seemed to require consideration of the clinical background.