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Performance of the Elecsys Rubella IgG assay in the diagnostic laboratory setting for assessment of immune status
Martin Enders1, Uwe Bartelt, Frank Knotek
1Laboratory Prof. Gisela Enders and Colleagues, MVZ, Stuttgart, Germany. menders@labor-enders.de
Insights
Congenital rubella infection poses significant risks during pregnancy. The Elecsys Rubella IgG assay demonstrates high sensitivity and specificity for screening, though quantitative result variations necessitate consistent assay use.
Area of Science:
- Immunology
- Virology
- Clinical Diagnostics
Background:
- Congenital rubella syndrome (CRS) can cause severe birth defects and long-term health issues.
- Maternal rubella immune status screening is crucial for preventing CRS.
- Despite vaccination, rubella virus infection remains a concern in pregnancy.
Purpose of the Study:
- To compare the performance of the Elecsys Rubella IgG assay against other routine screening methods.
- To evaluate the sensitivity and specificity of the Elecsys assay for rubella IgG detection.
- To assess quantitative differences in rubella IgG levels reported by various assays.
Main Methods:
- Comparative performance evaluation of diagnostic assays for rubella IgG.
- Testing of 1,090 antenatal care samples using Elecsys, Enzygnost, and hemagglutination inhibition (HAI) tests.
- Additional testing of low-titer samples (<32 HAI) with Vidas, AxSYM, Liaison, and Architect assays.
Main Results:
- All tested assays demonstrated 100.0% specificity for rubella IgG detection.
- Elecsys, AxSYM, and Enzygnost assays showed high sensitivity (>90.0%) in samples with low HAI titers.
- Significant quantitative variations in rubella virus IgG levels were observed between different immunoassays.
Conclusions:
- The Elecsys Rubella IgG assay is suitable for routine automated screening due to its high sensitivity and specificity for qualitative results.
- Considerable variation in quantitative results necessitates documenting testing methods and using the same assay throughout antenatal follow-up.
- Consistent use of a single assay minimizes variability in rubella IgG quantification during pregnancy management.
Abstract:
Rubella in early pregnancy bears a high risk for congenital defects (e.g., cataracts, hearing loss, and heart disease) and for long-term sequelae in the newborn. Despite implementation of vaccination programs in many regions, the threat of devastating consequences from congenital rubella virus infection remains and careful screening of maternal immune status before and during pregnancy helps to reduce the risk. This study compared the performance of the Elecsys Rubella IgG assay with that of other assays routinely used for screening. Samples from 1,090 women undergoing routine antenatal care were tested using the Elecsys and Enzygnost Rubella IgG assays and the hemagglutination inhibition test. Samples with hemagglutination inhibition titers of <32 (n = 148) were additionally tested using the Vidas, AxSYM, Liaison, and Architect Rubella IgG assays. Agreement of qualitative results from the Elecsys, Enzygnost, and hemagglutination inhibition assays was good in all samples. All assays showed 100.0% specificity. In samples with hemagglutination inhibition titers of <32, the Elecsys, AxSYM, and Enzygnost assays showed higher sensitivity (>90.0%) than the other immunoassays (78.6 to 82.4%). The Elecsys assay reported significantly higher rubella virus IgG levels than the other immunoassays across the whole set of 1,090 samples, with the largest bias and deviation from limits of agreement in Bland-Altman analysis. In conclusion, the Elecsys assay is highly sensitive and specific with regard to qualitative results and suitable for routine automated screening. However, given the considerable variation between quantitative results from different immunoassays, testing methods should be documented and the same assay used throughout an individual's antenatal follow-up wherever possible.
