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Test strip meconium screening for cystic fibrosis
American Journal of Diseases of Children (1960)
|January 1, 1977
Summary
The Boehringer-Mannheim Corporation (BMC) strip test reliably screens for cystic fibrosis in newborns. While effective, this meconium albumin test is not perfect, with some false positives and negatives in screening 16,224 infants.
Area of Science:
- Neonatal screening
- Biochemical diagnostics
- Genetic disorder detection
Background:
- Cystic fibrosis (CF) diagnosis in newborns is critical for early intervention.
- Meconium analysis offers a potential non-invasive screening method.
Purpose of the Study:
- To evaluate the reliability of the Boehringer-Mannheim Corporation (BMC) strip test for detecting elevated albumin in meconium as a screening tool for cystic fibrosis.
Main Methods:
- A prospective study screened 16,224 newborns over one year using the BMC strip test on dried meconium.
- The test detects albumin levels exceeding 20 mg/gm.
Main Results:
- The BMC strip test demonstrated high reliability in identifying elevated meconium albumin.
- Two out of 16,224 infants were correctly diagnosed with cystic fibrosis; two cases were missed.
- A 0.9% false-positive rate was observed, associated with prematurity, melena, gastroschisis, and intrauterine infection.
Conclusions:
- The BMC strip test is currently the best available screening method for cystic fibrosis in newborns.
- Despite its effectiveness, the test is not a perfect diagnostic tool and requires further confirmation.
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