For In Vitro Diagnostic Use
 
 MicroVue BAP 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.
 Specifications 
  
 
  
   
   | 8012 | 
  
   
   | ELISA | 
  
   
   | 96 wells/plate | 
  
   
   | Serum | 
 
 Intended Use 
 MicroVue 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 biophosphonate therapy;
- 
   prediction of skeletal response to hormonal therapy in postmenopausal women.
 
  
 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
 | 
  
   |  | 
 
 Performance Characteristics 
  
 
  
   
   | Immuno-capture | 
  
   
   | Bone alkaline phosphatase | 
  
   
   | Serum | 
  
   
   | 20 µL | 
  
   
   | 0.7 U/L | 
  
   
   | 2-140 U/L | 
  
   
   | 4-6% | 
  
   
   | 5-8% | 
  
   
   | 3.5 Hours | 
  
   
   | - Bone AP 100% - Liver AP 3-8%
 - Placenta AP 0%
 - Intestine AP 0.4%
 | 
  
   
   | - 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
 | 
 
 All Quidel assays are designed for laboratories equipped to perform microplate immunoassays as detailed on our Kit Format and Equipment Required page.