Reference Values

3.6-10.5 ng/mL

17-68 ng/mL - indeterminate.  Differential in this range would include biliary atresia, but also things like indeterminate cholestasis, choledocal cyst, alpha-1-antitrypsin deficiency.
 
>68 ng/mL - 95% specificity, 69% positive predictive value.  Above 68 ng/mL, the likelihood of biliary atresia is 95% 

Caution should be exercised in the interpretation of any assay for MMP-7, and the results should be considered in conjunction with the patient’s clinical condition. High MMP-7 have been detected in premature babies and young infants with cardiovascular and/ or multi-system disease. The final diagnosis of biliary atresia requires intraoperative cholangiography and the histological presence of obstruction of the extrahepatic bile duct. The normal values of MMP-7 in premature babies have not yet been established. Clinical correlation is particularly important in premature babies.

The performance characteristics of this assay were validated by the Metabolics Laboratory Children's Health. Reagents used in this assay are used in many lab tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration approval. Children's Health is authorized under the Clinical Laboratory Improvement Amendments of 1988(CLIA-88) to perform high complexity testing. This test should not be regarded as investigational or for research use.