Playing Rules for Evaluation of the Biomarker f Define Assay for Measurement AssayBindingIsotypeDNASens/Spec Crithidiahigh + low affinity absIgM or IgGdsDNAspec>sens Farrhigh affinity abs IgM and IgGss and dsDNA ELISAhigh + low affinity absIgM or IgGss or dsDNAsens>spec anti-DNA abs Complement Assay ComponentSpecimenMeasurement Immunochemical Native C3, C4serumNephelometry Functional integrity CH 50 EDTA plasmaRBC lysis Catabolic state Activation C3aEDTA plasmaELISA Define parameters of change for these candidate biomarkers
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