Researchers led by Paul Ridker at Brigham and Women's Hospital show that lipoprotein-associated phospholipase A2 mass, but not activity, is independently associated with cardiovascular disease. As they report in Clinical Chemistry, the researchers examined the link between Lp-PLA2 mass and activity with cardiovascular disease in 1,821 cases and 1,992 controls. However, the researchers note that the "the clinical utility of Lp-PLA2 mass remains questionable due to a lack of [risk] model improvement. More important are the high absolute levels for Lp-PLA2 mass seen in these data. The lack of standardization for this assay severely limits its potential clinical use."
In a Clinical Chemistry editorial, Boston Children's Hospital's Greg Miller and colleagues caution that using commercially available immunoassays for biomarker research can be problematic, especially if manufacturers do not provide adequate information about their assays. Miller and his colleagues say that researchers should examine inserts posted to company's websites prior to purchase and that such inserts should include information regarding calibration and assay performance, which users should confirm. "Both the manufacturers of assay kits and the researcher who uses them are responsible for assuring that the analytical quality of the assay is suitable for the intended use," the authors write, adding that "failure to address these matters will hinder our ability to conduct valid studies of biomarkers, and that may lead to serious errors in the evaluation of candidate biomarkers."