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Performance characteristics of six IMMULITE 2000 TORCH assays
William E Owen1, Thomas B Martins, Christine M Litwin
1ARUP Institute for Clinical and Experimental Pathology, University of Utah, Health Sciences Center, Salt Lake City 84108, USA.
American Journal of Clinical Pathology
|November 1, 2006
Summary
The IMMULITE 2000 TORCH assays demonstrate acceptable performance for routine clinical use. While generally good, Toxo IgM and RV IgM assays showed variable concordance with other commercial methods.
Area of Science:
- Clinical diagnostics
- Infectious disease serology
Background:
- TORCH infections (Toxoplasma gondii, other microorganisms, rubella virus, cytomegalovirus, herpes simplex virus) can cause congenital abnormalities.
- Accurate serological testing is crucial for diagnosing maternal infections and preventing fetal complications.
Purpose of the Study:
- To evaluate the performance of IMMULITE 2000 TORCH assays (Toxo IgG/IgM, RV IgG/IgM, CMV IgG, HSV IgG).
- To assess linearity, imprecision, and concordance with existing commercial methods.
Main Methods:
- Assessed linearity and imprecision of IMMULITE 2000 TORCH assays.
- Compared IMMULITE 2000 results with other commercially available TORCH assays.
- Analyzed concordance for Toxo IgM and RV IgM with multiple methods.
Main Results:
- IMMULITE 2000 assays demonstrated acceptable linearity and imprecision.
- Good concordance was observed for most assays compared to commercial methods.
- Toxo IgM and RV IgM assays showed variable concordance, with improved agreement noted against a consensus of methods.
Conclusions:
- IMMULITE 2000 TORCH assays are suitable for routine clinical use.
- Performance of Toxo IgM and RV IgM assays requires careful consideration due to variable concordance.
- Further evaluation of specific IgM assays is warranted.
