Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2013
Comparison of different IRT-PAP protocols to screen newborns for cystic fibrosis in three central European populations.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Sommerburg Olaf, Krulisova Veronika, Hammermann Jutta, Lindner Martin, Stahl Mirjam, Muckenthaler Martina, Kohlmueller Dirk, Happich Margit, Kulozik Andreas E, Votava Felix, Balascakova Miroslava, Skalicka Veronika, Stopsack Marina, Gahr Manfred, Macek Milan, Mall Marcus A, Hoffmann Georg F
Аннотация
BACKGROUND: In recent years different IRT/PAP protocols have been evaluated, but the individual performance remains unclear. To optimize the IRT/PAP strategy we compared protocols from three regional CF newborn screening centers (Heidelberg, Dresden, and Prague).
METHODS: We evaluated the effect of elevating the IRT-cut-off from 50 to 65 μg/l (~97.5th to ~99.0th percentile), the need of a failsafe protocol (FS, IRT ≥ 99.9th percentile) and the relative performance using either two IRT-dependent PAP-cut-offs or one PAP-cut-off.
FINDINGS: Elevation of the IRT cut-off to 65 μg/l (~99.0th percentile) increased the PPV significantly (Dresden: 0.065 vs. 0.080, p < 0.0001, Prague: 0.052 vs. 0.074, p < 0.0001) without reducing sensitivity. All three IRT/PAP protocols showed a trend towards a higher sensitivity with FS than without and when using one PAP-cut-off instead of two IRT-dependent PAP-cut-offs.
CONCLUSIONS: For best performance we suggest an IRT/PAP protocol with an IRT-cut-off close to the 99.0th percentile, FS, and a single PAP-cut-off.
METHODS: We evaluated the effect of elevating the IRT-cut-off from 50 to 65 μg/l (~97.5th to ~99.0th percentile), the need of a failsafe protocol (FS, IRT ≥ 99.9th percentile) and the relative performance using either two IRT-dependent PAP-cut-offs or one PAP-cut-off.
FINDINGS: Elevation of the IRT cut-off to 65 μg/l (~99.0th percentile) increased the PPV significantly (Dresden: 0.065 vs. 0.080, p < 0.0001, Prague: 0.052 vs. 0.074, p < 0.0001) without reducing sensitivity. All three IRT/PAP protocols showed a trend towards a higher sensitivity with FS than without and when using one PAP-cut-off instead of two IRT-dependent PAP-cut-offs.
CONCLUSIONS: For best performance we suggest an IRT/PAP protocol with an IRT-cut-off close to the 99.0th percentile, FS, and a single PAP-cut-off.
Предметные рубрики MeSH
Antigens, NeoplasmBiomarkers, TumorChemistry, ClinicalCystic FibrosisCystic Fibrosis Transmembrane Conductance RegulatorDried Blood Spot TestingEuropeGenetic TestingHumansInfant, NewbornLectins, C-TypeNeonatal ScreeningPancreatitis-Associated ProteinsProspective StudiesRetrospective StudiesSensitivity and SpecificityTrypsinogen