LDBio-Toxo II immunoglobulin G Western blot confirmatory test for anti-toxoplasma antibody detection.

Tests commonly used for routine determination of anti-Toxoplasma gondii immunoglobulin G (IgG) antibodies show a high level of consistency. However, considerable variations between commercial screening tests are still observed in detecting antibodies present at low concentrations, leading to a number of discrepant and/or equivocal results. It is therefore important to use a reference test to confirm borderline results. In this study, we evaluated the use of a new qualitative test based on Western blot analysis--the LDBio-Toxo II IgG test--as a confirmatory test for at-risk patients. The study was performed retrospectively, using 569 serum samples with "low-positive" (2 to 32 international units) anti-Toxoplasma IgG levels from 375 patients. These samples were either sera collected during the routine screening of pregnant women, from patients with unrelated infections, or from immunocompromised patients or sequential sera taken from pregnant women with acquired Toxoplasma infection or from their newborns during follow-up. The LDBio-Toxo II IgG test was compared to several commercial tests commonly used for anti-Toxoplasma IgG screening. The Sabin-Feldman dye test was used as a reference test. In this study, the results of the LDBio-Toxo II IgG test appeared to be consistent with those of the dye test; the LDBio-Toxo II IgG test had a specificity of 100% and a sensitivity of 99.2%. Our findings suggest that the LDBio-Toxo II IgG test is a useful serological tool in cases in which the presence or absence of Toxoplasma antibodies needs to be reliably determined, for example, for the follow-up of pregnant women and their newborns or for subjects with immune deficiencies following human immunodeficiency virus infection, hematological malignancies, or transplantation.