The BAP assay is not intended as a screening test for osteoporosis. The BAP results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests and other appropriate information.
Anti-resorptive therapies lower BAP from baseline measurements in Paget disease, osteomalacia, and osteoporosis. Several studies have shown that anti-resorptive therapies for management of osteoporosis patients should result in at least a 25% decrease in BAP within 3 to 6 months of initiating therapy. BAP also decreases following anti-resorptive therapy in Paget disease.
When used as a marker for monitoring purposes, it is important to determine the critical difference (or least significant change). The critical difference is defined as the difference between 2 determinations that may be considered to have clinical significance. The critical difference for this method was calculated to be 25% with a 95% confidence level. Therefore, changes in BAP concentrations that exceed 25% may be attributed to changes in bone remodeling.
Liver-derived alkaline phosphatase (ALP) has some cross-reactivity in this assay: 100 U/L of liver ALP activity gives a result of 2.5 g/L to 5.8 g/L. Accordingly, serum specimens with significant elevations of liver ALP activity may yield elevated results.