Key result
The Roche assay for HDL-cholesterol yielded a false negative result in a patient with a monoclonal IgMkappa concentration of 55.8 g/L, and may cause false low results in similar patients.
Why the study?
Does monoclonal or polyclonal hypergammaglobulinaemia cause false negative results in the Roche assay for HDL-cholesterol?
Case Report
Does monoclonal or polyclonal hypergammaglobulinaemia cause false negative results in the Roche assay for HDL-cholesterol?
False low HDL-cholesterol results in the Roche assay due to hypergammaglobulinaemia may lead to altered vascular risk estimates and unnecessary treatment.
Measurement of HDL-cholesterol is important in the risk evaluation of cardiovascular disease. Recently, we encountered a 61-year-old man with a negative result for HDL-cholesterol using the Roche assay. Further analysis revealed that this patient had a monoclonal Ig type IgMkappa, with an electrophoresis-based concentration of 55.8 g/L, which apparently caused the negative result for HDL-cholesterol. Analysis of serum samples from other patients with monoclonal or polyclonal hypergammaglobulinaemia revealed that false negative results in the Roche assay for HDL-cholesterol may occur incidentally. Since negative results are detected easily in the laboratory, such patients do not pose a problem in daily practice. However, it is reasonable to suppose that false low results could also be caused by monoclonal as well as polyclonal Igs. Since such false low results remain undetected, vascular risk estimates consequently are altered and unnecessary treatment might be started.
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Bakker et al. (2003) conducted a case report in Monoclonal or polyclonal hypergammaglobulinaemia. Roche assay for HDL-cholesterol was evaluated on False negative results for HDL-cholesterol. The Roche assay for HDL-cholesterol yielded a false negative result in a patient with a monoclonal IgMkappa concentration of 55.8 g/L, and may cause false low results in similar patients.
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