Inter-method variability in bone alkaline phosphatase measurement: clinical impact on the management of dialysis patients.

BACKGROUND Bone-specific alkaline phosphatase (BAP) is now recommended to assess bone turnover in hemodialysis (HD) patients. However, little is known about potential variability between methods available to measure BAP. METHODS We measured BAP in 76 HD patients with six different assays (Beckman-Coulter Ostase IRMA, Beckman-Coulter Ostase Access, IDS iSYS Ostase, IDS Ostase enzyme immunoassay, DiaSorin Liaison Ostase and Quidel MicroVue BAP). RESULTS We observed a high correlation between all the assays ranging from 0.9948 (IDS iSYS vs. IDS EIA) to 0.9215 (DiaSorin Liaison vs. Quidel MicroVue). However, using the regression equations, the equivalent concentration of a Beckman-Coulter Access value of 10 μg/L can range from 7.7 to 14.4 μg/L and of 20 μg/L can range from 16.9 to 27.9 μg/L with other assays. According to Beckman-Coulter Access, 13%, 50% and 37% of the patients presented BAP values ≤10, between 10 and 20 and ≥20 μg/L, respectively. Discrepancies are observed when other assays are used (concordance from 10 to 100%). CONCLUSIONS Analytical problems leading to inter-method variation should be overcome to improve the usefulness of this marker in clinical practice. According to correlation results, recalibration of BAP assays is necessary but should not be a major issue.