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IRT/IRT as a newborn cystic fibrosis screening method: optimal cutoff points for a mixed population.
Godoy, Carolina; Brito, Pedro Paulo; Amorim, Tatiana; Souza, Edna Lúcia; Boa-Sorte, Ney.
Afiliación
  • Godoy C; Programa de Pós-graduação em Medicina e Saúde, Universidade Federal da Bahia, Salvador, Brasil.
  • Brito PP; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brasil.
  • Amorim T; Associação de Pais e Amigos dos Excepcionais, Salvador, Brasil.
  • Souza EL; Universidade do Estado da Bahia, Salvador, Brasil.
  • Boa-Sorte N; Programa de Pós-graduação em Medicina e Saúde, Universidade Federal da Bahia, Salvador, Brasil.
Cad Saude Publica ; 40(7): e00150623, 2024.
Article en En | MEDLINE | ID: mdl-39194088
ABSTRACT
The Brazilian Unified National Health System (SUS) has incorporated newborn screening for cystic fibrosis since 2001. The protocol involves two samples of immunoreactive trypsinogen (IRT1/IRT2). This study aims to analyze fixed and floating values at the first and second IRT (IRT1/IRT2) cutoff points and assess the accuracy of the IRT/IRT methodology in a population from Northeastern Brazil. Descriptive, individual-level data from the newborn screening reference service data system (2013-2017) were used in this observational population study. The sensitivity, specificity, and positive predictive values (PPV) for the protocol were calculated. The best cutoff point was determined using the Youden's index. The previous year's cut-off values for the IRT1 and IRT2 99.4-, 99.5-, 99.6-, and 99.7-percentiles were utilized for the floating cutoff. During the studied period, 840,832 newborns underwent screening for cystic fibrosis, obtaining 49 cystic fibrosis diagnoses 39 by newborn screening (79.6%) and 10 (20.4%) by clinical suspicion (false negative). The sensitivity, specificity, and PPV of the protocol totaled 79.6%, 99.9%, and 6.1%, respectively. No proposed cutoff for IRT1 performed better than the current one. IRT2 performed similarly to the current protocol at a cutoff point of 90ng/mL, showing the appropriate sensitivity and specificity while reducing the frequency of false positives. The protocol to screen newborns for cystic fibrosis had low sensitivity, a predictive positive value, and a high number of false positives and negatives. A floating cut point for IRT1 or IRT2 seems to constitute no viable option. However, changing the IRT2 cut point from 70ng/mL to 90ng/mL seems to have advantages and should undergo consideration.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tripsinógeno / Sensibilidad y Especificidad / Tamizaje Neonatal / Fibrosis Quística Límite: Female / Humans / Male / Newborn País/Región como asunto: America do sul / Brasil Idioma: En Revista: Cad Saude Publica Asunto de la revista: SAUDE PUBLICA Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Brasil
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tripsinógeno / Sensibilidad y Especificidad / Tamizaje Neonatal / Fibrosis Quística Límite: Female / Humans / Male / Newborn País/Región como asunto: America do sul / Brasil Idioma: En Revista: Cad Saude Publica Asunto de la revista: SAUDE PUBLICA Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Brasil