Evaluation of formulae for CSF IgG synthesis using data obtained from two methods: importance of receiver operator characteristic curve analysis.

Abstract

To determine the clinical performance of three cerebrospinal fluid (CSF) IgG synthesis formulae using data obtained from two quantitation methods. Receiver operator characteristic (ROC) analysis and decision index plots were used to compare a rate nephelometric (RN) and a rocket immunoelectrophoretic (RIEP) method for quantitating albumin and IgG for use in CSF IgG synthesis formulae. Further analysis was used to determine the most clinically accurate of these formulae for a diagnosis of multiple sclerosis with regard to technical accuracy and cost effectiveness. Values for albumin and IgG determined by RN gave better sensitivities and specificities than the RIEP method when applied to all three formulae; however, when the 95% confidence limits were considered, the difference was not significant. Using the RN method with an agreed "rule in" threshold value of 90% specificity, the IgG index gave the best clinical performance. ROC curve analysis and decision index plots provide valuable tools in assessing and comparing the clinical performance of new and existing laboratory assays.