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13C-Mixed Triglyceride Breath Test and Fecal Elastase as an Indirect Pancreatic Function Test in Cystic Fibrosis
Dorothea Stark Kent1, Thomas Remer2, Caron Blumenthal1,3
1James Fairfax Institute of Paediatric Nutrition, University of Sydney, Sydney, Australia.
Insights
New tests for pancreatic function in infants with cystic fibrosis (CF) show promise for detecting insufficiency but fail to reliably identify pancreatic sufficiency. The C-mixed triglyceride breath test and fecal elastase-1 tests are not yet suitable alternatives to the fecal fat test.
Area of Science:
- Pediatrics
- Gastroenterology
- Genetics
Background:
- The 72-hour fecal fat excretion test is the standard for assessing pancreatic function in infants with cystic fibrosis (CF).
- This traditional method is facing obsolescence, necessitating evaluation of alternative diagnostic tools.
- Accurate pancreatic function assessment is crucial for determining the pancreatic phenotype in CF infants.
Purpose of the Study:
- To evaluate the clinical utility of the C-mixed triglyceride (MTG) breath test and fecal elastase-1 (FE1) as indirect pancreatic function tests in infants with CF.
- To compare the diagnostic accuracy of these novel tests against the established 72-hour fecal fat assessment.
Main Methods:
- A comparative study involving 24 infants with CF.
- The C-MTG breath test and two types of FE1 tests (monoclonal and polyclonal) were performed.
- Tests were conducted after withholding oral pancreatic enzyme replacement therapy (PERT).
Main Results:
- Both C-MTG breath test and FE1 tests demonstrated high sensitivity (82%-100%) in identifying pancreatic insufficiency in CF patients.
- However, sensitivity rates for detecting pancreatic-sufficient CF patients were unacceptably low for C-MTG (31%-38%) and FE1 tests (45%-54%).
Conclusions:
- The C-MTG breath test and FE1 tests are not yet reliable alternatives to the fecal fat balance test for evaluating pancreatic function in infants with CF within their first year of life.
- Further refinement and validation are needed for these noninvasive tests to accurately assess both pancreatic insufficiency and sufficiency in this population.
Background:
The 'gold standard' test for the indirect determination of pancreatic function status in infants with cystic fibrosis (CF), the 72-hour fecal fat excretion test, is likely to become obsolete in the near future. Alternative indirect pancreatic function tests with sufficient sensitivity and specificity to determine pancreatic phenotype need further evaluation in CF infants.
Objective:
Evaluation of the clinical utility of both the noninvasive, nonradioactive C-mixed triglyceride (MTG) breath test and fecal elastase-1 (FE1) in comparison with the 72-hour fecal fat assessment in infants with CF.
Methods:
C-MTG breath test and the monoclonal and polyclonal FE1 assessment in stool was compared with the 72-hour fecal fat assessment in 24 infants with CF. Oral pancreatic enzyme substitution (PERT; if already commenced) was stopped before the tests.
Results:
Sensitivity rates between 82% and 100% for CF patients with pancreatic insufficiency assessed by both the C-MTG breath test and the FE1 tests proved to be high and promising. The C-MTG breath test (31%-38%) as well as both FE1 tests assessed by the monoclonal (46%-54%) and the polyclonal (45%) ELISA kits, however, showed unacceptably low-sensitivity rates for the detection of pancreatic-sufficient CF patients in the present study.
Conclusions:
The C-MTG breath test with nondispersive infrared spectroscopy (NDIRS) technique, as well as both FE1 tests, are not alternatives to the fecal fat balance test for the evaluation of pancreatic function in CF infants during the first year of life.
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