Evidence map›Paper›PMID 33072991›Full record

ArticleInternational journal of neonatal screening2019

Initial Evaluation of Prospective and Parallel Assessments of Cystic Fibrosis Newborn Screening Protocols in Eastern Andalusia: IRT/IRT versus IRT/PAP/IRT.

Ilham Sadik, Inmaculada Pérez de Algaba, Rocío Jiménez, Carmen Benito, Javier Blasco-Alonso, Pilar Caro, Víctor M Navas-López, Javier Pérez-Frías, Estela Pérez, Juliana Serrano and 1 more

Abstract read
In one paragraph

Article in International journal of neonatal screening, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Observational
  4. Article
  5. Neonatal Screening for Cystic Fibrosis in Hungary-First-Year Experiences.International journal of neonatal screening · 2023
    Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ilham SadikClinical Laboratory, Hospital La Línea de la Concepción, 11300 Cádiz, Spain.
Inmaculada Pérez de AlgabaLaboratory of Metabolic Disorders and Newborn Screening Center of Eastern Andalusia, Málaga Regional University Hospital, Avenida Arroyo de los Angeles s/n, 29011 Málaga, Spain.
Rocío JiménezLaboratory of Metabolic Disorders and Newborn Screening Center of Eastern Andalusia, Málaga Regional University Hospital, Avenida Arroyo de los Angeles s/n, 29011 Málaga, Spain.
Carmen BenitoDepartment of Genetics, Málaga Regional University Hospital, 29011 Málaga, Spain.
Javier Blasco-AlonsoDepartment of Pediatrics, Málaga Regional University Hospital, 29011 Málaga, Spain.
Pilar CaroDepartment of Pediatrics, Málaga Regional University Hospital, 29011 Málaga, Spain.
Víctor M Navas-LópezDepartment of Pediatrics, Málaga Regional University Hospital, 29011 Málaga, Spain.
Javier Pérez-FríasDepartment of Pediatrics, Málaga Regional University Hospital, 29011 Málaga, Spain.ORCID https://orcid.org/0000-0002-5515-3034
Estela PérezDepartment of Pediatrics, Málaga Regional University Hospital, 29011 Málaga, Spain.
Juliana SerranoDepartment of Pediatrics, Málaga Regional University Hospital, 29011 Málaga, Spain.
Raquel YahyaouiLaboratory of Metabolic Disorders and Newborn Screening Center of Eastern Andalusia, Málaga Regional University Hospital, Avenida Arroyo de los Angeles s/n, 29011 Málaga, Spain.ORCID https://orcid.org/0000-0001-6789-1563

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Identifying newborns at risk for cystic fibrosis (CF) by newborn screening (NBS) using dried blood spot (DBS) specimens provides an opportunity for presymptomatic detection. All NBS strategies for CF begin with measuring immunoreactive trypsinogen (IRT). Pancreatitis-associated protein (PAP) has been suggested as second-tier testing. The main objective of this study was to evaluate the analytical performance of an IRT/PAP/IRT strategy versus the current IRT/IRT strategy over a two-year pilot study including 68,502 newborns. The design of the study, carried out in a prospective and parallel manner, allowed us to compare four different CF-NBS protocols after performing a post hoc analysis. The best PAP cutoff point and the potential sources of PAP false positive results in our non-CF newborn population were also studied. 14 CF newborns were detected, resulting in an overall CF prevalence of 1/4, 893 newborns. The IRT/IRT algorithm detected all CF cases, but the IRT/PAP/IRT algorithm failed to detect one case of CF. The IRT/PAP/IRT with an IRT-dependent safety net protocol was a good alternative to improve sensitivity to 100%. The IRT × PAP/IRT strategy clearly performed better, with a sensitivity of 100% and a positive predictive value (PPV) of 39%. Our calculated optimal cutoffs were 2.31 µg/L for PAP and 167.4 µg

Indexed as

cystic fibrosisdried blood spot (DBS)immunoreactive trypsinogen (IRT)newborn screening (NBS)pancreatitis-associated protein (PAP)

Identifiers

PMID33072991
PMCPMC7510193

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.