Basic study of “Runpia latex RUBELLA” as a reagent for anti-rubella viral antibody measurement

Abstract

The Ministry of Health, Labour and Welfare announced the implementation of free vaccination against rubella for the general public over a period of approximately three years (from 2019 to the end of fiscal year 2021), targeting males born between 1962 and 1979, who did not have the opportunity to be vaccinated for rubella. Currently, rubella is diagnosed mainly by the hemagglutination inhibition (HI) method, which requires a long assay time owing to its complicated and manual handling procedure. We performed a fundamental evaluation of “Runpia latex RUBELLA”, a latex turbidimetric immunoassay method involving anti-rubella viral antibody measurement, which can be carried out with an automated analyzer. The within-run and between-run coefficients of variation (CVs) of quality control samples are less than 7.0%, the dilution linearity is good (correlation: r ≤ 0.998), there are no effects of interfering substances, and the detection limit is 3.5 IU/mL. The correlation between the HI method and Runpia latex RUBELLA is good (Spearman’s rank correlation: r = 0.952, n = 150). A RUBELLA concentration of 2,300 IU/mL in a sample did not decrease in the measurement upper limit. Runpia latex RUBELLA can be used to replace the HI method and it showed sufficient reagent performance in a routine test using an automatic analyzer.