Bone Alkaline Phosphatase, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosis and assessment of severity of metabolic bone disease including Paget disease, osteomalacia, and other states of high bone turnover
Monitoring efficacy of antiresorptive therapies including postmenopausal osteoporosis treatment
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Bone Alkaline Phosphatase, S
Skeletal Alkaline Phosphatase
Skeletal Alkaline Phosphatase
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.6 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Bone alkaline phosphatase (BAP) is the bone-specific isoform of alkaline phosphatase. A glycoprotein that is found on the surface of osteoblasts, BAP reflects the biosynthetic activity of these bone-forming cells. BAP has been shown to be a sensitive and reliable indicator of bone metabolism.(1)
Normal bone is constantly undergoing remodeling in which bone degradation or resorption is balanced by bone formation. This process is necessary for maintaining bone health. If the process becomes uncoupled and the rate of resorption exceeds the rate of formation, the resulting bone loss can lead to osteoporosis and, consequently, a higher susceptibility to fractures.
Osteoporosis is a metabolic bone disease characterized by low bone mass and abnormal bone microarchitecture. It can result from a number of clinical conditions including states of high bone turnover, endocrine disorders (primary and secondary hyperparathyroidism and thyrotoxicosis), osteomalacia, renal failure, gastrointestinal diseases, long-term corticosteroid therapy, multiple myeloma, and cancer metastatic to the bones.
Paget disease is another common metabolic bone disease caused by excessive rates of bone remodeling resulting in local lesions of abnormal bone matrix. These lesions can result in fractures or neurological involvement. Antiresorptive therapies are used to restore the normal bone structure.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
<2 years: 25-221 mcg/L
2-9 years: 27-148 mcg/L
10-13 years: 35-169 mcg/L
14-17 years: 13-111 mcg/L
Adults: < or =20 mcg/L
<2 years: 28-187 mcg/L
2-9 years: 31-152 mcg/L
10-13 years: 29-177 mcg/L
14-17 years: 7-41 mcg/L
Premenopausal: < or =14 mcg/L
Postmenopausal: < or =22 mcg/L
Bone alkaline phosphatase (BAP) concentration is high in Paget disease and osteomalacia.
Antiresorptive therapies lower BAP from baseline measurements in Paget disease, osteomalacia, and osteoporosis. Several studies have shown that antiresorptive therapies for management of osteoporosis patients should result in at least a 25% decrease in BAP within 3 to 6 months of initiating therapy.(2,3) BAP also decreases following antiresorptive therapy in Paget disease.(4)
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.(1)
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The assay is not intended as a screening test for osteoporosis. Assay results should be used only in conjunction with information available from the clinical evaluation of the patient and other diagnostic procedures.
Measurements of bone turnover markers are not useful for the diagnosis of osteoporosis; diagnosis of osteoporosis should be made on the basis of bone density.
Human antimouse or other heterophile antibodies may be present in patient specimens. Although the assay has been specifically formulated to minimize their effects on the assay, results from patients known to have these antibodies should be carefully evaluated.
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 mcg/L to 5.8 mcg/L. Accordingly, serum specimens with significant elevations of liver ALP activity may yield elevated results.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Kress BC: bone alkaline phosphatase: methods of quantitation and clinical utility. J Clin Ligand Assay 1998;21(2):139-148
2. Kress BC, Mizrahi IA, Armour KW, et al: Use of bone alkaline phosphatase to monitor alendronate therapy in individual postmenopausal osteoporotic women. Clin Chem 1999;45(7):1009-1017
3. Garnero P, Darte C, Delmas PD: A model to monitor the efficacy of alendronate treatment in women with osteoporosis using a biochemical marker of bone turnover. Bone 1999;24(6):603-609
4. Raisz L, Smith JA, Trahiotism M, et al: Short-term risedronate treatment in postmenopausal women: Effects on biochemical markers of bone turnover. Osteoporos Int 2000;11:615-620
Method Description Describes how the test is performed and provides a method-specific reference
The instrument used is a Beckman Coulter Unicel DXI 800. The Access Ostase assay is a one step immunoenzymatic assay used to measure bone alkaline phosphatase (BAP) in human serum. The assay utilizes a mouse monoclonal antibody specific to BAP and paramagnetic particles coated with goat antimouse antibodies. BAP in the patient's specimen binds to the anti-BAP mouse antibody, which in turn is captured by the solid phase antimouse antibody. After washing to remove any unbound material, a chemiluminescent substrate is added to the reaction vessel. The BAP present acts on the substrate to produce light, which is measured with a uminometer. The amount of light produced is directly proportional to the amount of BAP in the specimen. The amount of analyte in the specimen is determined from a stored, multipoint calibration curve. (Package insert: Access Ostase. Beckman-Coulter, Brea, CA, 2010)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday 5 a.m. – midnight, Saturday 6 a.m. – 6 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|BAP||Bone Alkaline Phosphatase, S||17838-4|