[What EIA assay levels correspond to rubella antibody HI assay titer?].

In 2004, a Japanese-government-supported research group recommended that women without rubella antibody or with low titers < or = 1:16 of HI antibody should be vaccinated to decrease the risk of congenital rubella syndrome. We compared HI antibody titer with EIA-IgG levels in 520 college students with < or = 1:64, HI antibody measuring rubella antibodies in the same specimen using HI and EIA assay kits from Denka Seiken Co. (Japan) and Dade Behring Co. (Germany). The positive predictive value of the EIA assay using the kit from Denka Seiken Co. was 99.8% and the negative predictive value 91.3%, respectively, compared to 97.9% (positive > or = 15 IU/mL), 98.1% (positive > or = 10 IU/mL), and 93.4%, using the kit from Dade Behring Co. Between HI titers and EIA-IgG measured with the Denka kit, the coefficient index was 0.715 (p < 0.0001). Between those measured with the Dade kit, the coefficient index was 0.610 (p < 0.0001). Between EIA-IgG levels measured using the two kits, the coefficient index was 0.753 (p < 0.0001). The HI value of 1:16 corresponds approximately to 9.0 with the kit (positive > or = 4.0) from Denka, and to 30 IU/mL with the kit from Dade. EIA-IgG levels > or = 10 IU/mL are considered globally as protective antibody titers, meaning that the Japanese recommendation of < or = 1:16 for vaccination is too loose. Japanese EIA kit values for the rubella antibody should also be expressed in IU/mL using the global standard.