* Place specimen on ice after collection and deliver to lab immediately*
What color tube to draw
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
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
