Collect

Plain red top tube or serum separator tube.

* Place specimen on ice after collection and deliver to lab immediately* 

What color tube to draw

Plain red top or Serum Separator Tube

Required volume to collect

2 mL

Unacceptable/causes for rejection

Thawed samples, plasma samples

Performed

CMC DALLAS LABORATORY: Metabolics Department


Monday, Wednesday, and Friday*
*Testing not performed on holidays or weekends

Specimen Preparation

Sample must be processed within 2 hours of collection.  Avoid repeated freeze/thaw cycles.

Storage/transport requirements

Ship on dry ice sufficient to maintain temperature, thawed samples will be rejected. Avoid repeated freeze/thaw cycles.

Reference Interval

3.6-10.5 ng/mL

Interpretive Data

< 17 ng/mL - 95% sensitivity, 97% negative predictive value.  Below 17 ng/mL, the chance is 95% that biliary atresia will not be present.
 
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.
 

Unacceptable/causes for rejection

Thawed samples, plasma samples

Unacceptable Conditions

Thawed samples, plasma samples

Performed

CMC DALLAS LABORATORY: Metabolics Department


Monday, Wednesday, and Friday*
*Testing not performed on holidays or weekends

Methodology

ELISA

CPT Codes

83520

Performing Lab

Children's Medical Center-Dallas
Metabolics Laboratory
1935 Medical District Dr. 
Dallas, TX 75235
Collection

Collect

Plain red top tube or serum separator tube.

* Place specimen on ice after collection and deliver to lab immediately* 

What color tube to draw

Plain red top or Serum Separator Tube

Required volume to collect

2 mL

Unacceptable/causes for rejection

Thawed samples, plasma samples

Performed

CMC DALLAS LABORATORY: Metabolics Department


Monday, Wednesday, and Friday*
*Testing not performed on holidays or weekends
Collection Process

Specimen Preparation

Sample must be processed within 2 hours of collection.  Avoid repeated freeze/thaw cycles.
Labeling
Storage/Transport/Temperatures

Storage/transport requirements

Ship on dry ice sufficient to maintain temperature, thawed samples will be rejected. Avoid repeated freeze/thaw cycles.
Result Interpretation

Reference Interval

3.6-10.5 ng/mL

Interpretive Data

< 17 ng/mL - 95% sensitivity, 97% negative predictive value.  Below 17 ng/mL, the chance is 95% that biliary atresia will not be present.
 
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.
 
Rejection reasons

Unacceptable/causes for rejection

Thawed samples, plasma samples

Unacceptable Conditions

Thawed samples, plasma samples
Ordering

Performed

CMC DALLAS LABORATORY: Metabolics Department


Monday, Wednesday, and Friday*
*Testing not performed on holidays or weekends

Methodology

ELISA
Reflexs to additional testing
Administrative

CPT Codes

83520

Performing Lab

Children's Medical Center-Dallas
Metabolics Laboratory
1935 Medical District Dr. 
Dallas, TX 75235
Test Last Updated

×
Learn More Remind Me Later Dismiss