Performance Evaluation of Anti-rubella IgM and IgG Antibodies by Roche Modulddar Analytics E170 / 임상검사와정도관리

ABSTRACT

BACKGROUND: The tests for the anti-rubella antibodies are important in early pregnancies because the risk of congenital anomaly should be considered depending on the results. We would like to evaluate analytical performance of Roche Modular Analytics E170 (Roche Diagnostics, Mannheim, Germany; E170) for anti-rubella antibodies. METHODS: For the comparison studies, a total of 436 sera from pregnant or fertile women was used for the detection of anti-rubella antibodies by E170 and VIDAS analyzer. The precision of E170 for serum anti-rubella IgM and IgG were also evaluated. RESULTS: In the precision study, within-run and total CV of anti-rubella IgM and IgG were below 5%. In the comparison study, the agreement of E170 with VIDAS was above 90%. CONCLUSIONS: The E170 showed a satisfactory precision for anti-rubella antibodies and a high level of concordance with VIDAS. Therefore, E170 would be useful as a routine immunoassay analyzer for measuring anti-rubella IgM and IgG antibodies.