Aims: To determine the clinical performance of three cerebrospinal fluid (CSF) IgG synthesis formulae using data obtained from two quantitation methods.
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.
Results: 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.
Conclusion: ROC curve analysis and decision index plots provide valuable tools in assessing and comparing the clinical performance of new and existing laboratory assays.