For In Vitro Diagnostic Use.

The MicroVue BAP EIA provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum. BAP is an enzyme produced by osteoblasts, the cells responsible for bone formation. The MicroVue BAP immuno***** provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum as an indicator of osteoblastic activity.

Measurement of BAP is intended for use as an aid in the:

• management of postmenopausal osteoporosis and Paget's disease;
• monitoring of postmenopausal women on hormonal or bisphosphonate therapy;
• prediction of skeletal response to hormonal therapy in postmenopausal women.

  Performance Characteristics

  Method: Immuno-capture
  Analyte: Bone alkaline phosphatase
  Specimen: Serum
  Specimen Volume: 20 μL
  Sensitivity: 0.7 U/L
  Dynamic Range: 2-140 U/L
  Precision CVs within-run: 4-6%
  Precision CVs between-run: 5-8%
  Incubation Time: 3.5 Hours
  Cross-reactivity:
      Bone AP 100% 
      Liver AP 3-8%
      Placenta AP 0%
      Intestine AP 0.4%
  Expected Values:
      Females 25-44 yr. premenopausal: 11.6-29.6 U/L
      Females ≥ 45 yr. postmenopausal: 14.2-42.7 U/L
      Males ≥ 25 yr.: 15.0 - 41.3 U/L

  About the Assay

  Format

  96-well microplate with reagents sufficient to test 40 samples in duplicate

  Species Reactivity

  Rabbit, Pig, Dog, Sheep, Goat, Cow, Horse, Cynomolgus Monkey, Human Cell Culture. No recognition of Rat or Mouse

  Assay Steps

  • Add 125 μL Assay Buffer
  • Add 20 μL Standards, Controls, and samples; swirl
  • Incubate 3 hours ± 10 minutes at room temperature
  • Wash 4 times with 1X Wash Buffer
  • Add 150 μL room temperature Working Substrate Solution
  • Incubate 30 ± 5 minutes at room temperature
  • Add 100 μL Stop Solution and read OD at 405 nm
  • Data Reduction: Quadratic curve