Truth and discrimination | The assay for measurement of serum urate (SU) is reproducible according to reliability analysis |
The effects of sources of variability on SU concentrations in appropriate controls are known for the following core variables — age, sex, ethnicity, circadian rhythms, body mass index, renal/hepatic function, fasting/non-fasting |
SU demonstrates independent association with clinical and patient-centered endpoints. The key clinical/patient-centered endpoints in chronic gout are number of gout flares, tophus regression, dissolution of crystals, radiographic damage, and patient function and quality of life |
Feasibility | The assay for measurement of SU is internationally standardized (availability of reference standards), and is readily accessible if used for clinical practice |
Stability of SU at room temperature, in frozen specimens, after repeat freeze/thaw cycles, and after longterm storage has been documented |