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Comparison between two newborn screening strategies for cystic fibrosis in Argentina: IRT/IRT vs. IRT/PAP
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  • Alejandro Teper,
  • Fernando Smithius,
  • Viviana Rodriguez,
  • Orlando Salvaggio,
  • Gustavo Maccallini,
  • Claudio Aranda,
  • Silvina Lubovich,
  • Silvina Zaragoza,
  • Facundo Garcia-Bournissen
Alejandro Teper
El Hospital de Niños Ricardo Gutierrez
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Fernando Smithius
Hospital General de Agudos Carlos G Durand
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Viviana Rodriguez
El Hospital de Niños Ricardo Gutierrez
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Orlando Salvaggio
El Hospital de Niños Ricardo Gutierrez
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Gustavo Maccallini
Hospital General de Agudos Carlos G Durand
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Claudio Aranda
Hospital General de Agudos Carlos G Durand
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Silvina Lubovich
El Hospital de Ninos Ricardo Gutierrez
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Silvina Zaragoza
El Hospital de Ninos Ricardo Gutierrez
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Facundo Garcia-Bournissen
University of Western Ontario Schulich School of Medicine and Dentistry
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Abstract

Background: Benefits of early Cystic Fibrosis (CF) detection using newborn screening (NBS) lead to widespread use in NBS programs. Since 2002, a two-stage immunoreactive trypsinogen (IRT/IRT) screening strategy has been used as CFNBS method in all public maternities in the City of Buenos Aires, Argentina. However, novel screening strategies may be more efficient. The aim of the study is to prospectively compare two CFNBS strategies, IRT/IRT and IRT/PAP (pancreatitis-associated protein). Methods: A two-year prospective study was performed. IRT was measured in dried blood samples collected 48–72 hours after birth. When IRT value was abnormal, PAP was determined, and a second visit was scheduled to obtain another sample for IRT before 25 days of life. Newborns with a positive CFNBS were referred for confirmatory sweat test. Results: There were 69,827 births in the City of Buenos Aires during the period studied; 918 (1.31%) had an abnormal IRT. A total of 207 children (22.5%) failed to return for the second IRT, but only two PAP (0.2%) were not performed. IRT/IRT was more likely to lead to a referral for sweat testing than IRT/PAP (OR 2.3 [95% CI 1.8;2.9], p<0.001). Sensitivity, specificity, positive predictive value, and negative predictive value were: 80% and 100%, 86.5% and 82.6%, 4.04% and 4.2%, 99.84% and 100% for IRT/IRT and IRT/PAP strategies, respectively. Conclusion: The IRT/PAP strategy is more sensitive than IRT/IRT; it avoids a second appointment and the need of unnecessary sweat testing, and decreases loss to follow up in our population.

Peer review status:Published

03 Jun 2020Submitted to Pediatric Pulmonology
03 Jun 2020Submission Checks Completed
03 Jun 2020Assigned to Editor
06 Jun 2020Reviewer(s) Assigned
13 Jul 2020Review(s) Completed, Editorial Evaluation Pending
16 Jul 2020Editorial Decision: Revise Major
19 Aug 20201st Revision Received
19 Aug 2020Assigned to Editor
19 Aug 2020Reviewer(s) Assigned
19 Aug 2020Submission Checks Completed
20 Sep 2020Review(s) Completed, Editorial Evaluation Pending
22 Sep 2020Editorial Decision: Revise Minor
29 Sep 20202nd Revision Received
30 Sep 2020Assigned to Editor
30 Sep 2020Submission Checks Completed
30 Sep 2020Reviewer(s) Assigned
05 Oct 2020Review(s) Completed, Editorial Evaluation Pending
05 Oct 2020Editorial Decision: Revise Minor
06 Oct 20203rd Revision Received
07 Oct 2020Submission Checks Completed
07 Oct 2020Assigned to Editor
10 Oct 2020Review(s) Completed, Editorial Evaluation Pending
10 Oct 2020Editorial Decision: Revise Minor
10 Oct 20204th Revision Received
12 Oct 2020Submission Checks Completed
12 Oct 2020Assigned to Editor
14 Oct 2020Review(s) Completed, Editorial Evaluation Pending
14 Oct 2020Editorial Decision: Accept
23 Oct 2020Published in Pediatric Pulmonology. 10.1002/ppul.25130