Evidence map›Paper›PMID 34186488›Full record

ArticleEBioMedicine2021

Prospective multicenter evaluation of real time PCR Kit prototype for early diagnosis of congenital Chagas disease.

Alejandro Francisco Benatar, Emmaría Danesi, Susana Alicia Besuschio, Santiago Bortolotti, María Luisa Cafferata, Juan Carlos Ramirez, Constanza Lopez Albizu, Karenina Scollo, María Baleani, Laura Lara and 15 more

Open access · goldAbstract readEvaluation StudyMulticenter Study
In one paragraph

Article in EBioMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% of its field
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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Frontiers in microbiology · 2024
    Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Clinical use of molecular methods forFrontiers in parasitology · 2023
    Article
  17. Laboratory diagnosis ofFrontiers in parasitology · 2023
    Review
  18. Review
  19. 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

25 authors at 7 institutions in 3 countries.

Alejandro Francisco BenatarLaboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh) Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr Héctor Torres" (INGEBI) - Consejo Nacional de Investigaciones Científicas y Técnicas, CONICET; Ciudad Autónoma de Buenos Aires, Argentina.
Emmaría DanesiCentro Nacional de Diagnóstico e Investigación en Endemoepidemias (ANLIS Dr. C. G. Malbrán, Ciudad Autónoma de Buenos Aires, Argentina).
Susana Alicia BesuschioLaboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh) Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr Héctor Torres" (INGEBI) - Consejo Nacional de Investigaciones Científicas y Técnicas, CONICET; Ciudad Autónoma de Buenos Aires, Argentina.
Santiago BortolottiCentro de Investigación y Biotecnología (CIBIO) de Wiener Laboratorios SAIC, Rosario, Pcia. de Santa Fe, Argentina.
María Luisa CafferataDepartamento en Salud de la Madre y el Niño, Instituto de Efectividad Clínica y Sanitaria, Ciudad Autónoma de Buenos Aires, Argentina.
Juan Carlos RamirezLaboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh) Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr Héctor Torres" (INGEBI) - Consejo Nacional de Investigaciones Científicas y Técnicas, CONICET; Ciudad Autónoma de Buenos Aires, Argentina.
Constanza Lopez AlbizuInstituto Nacional de Parasitología Dr. M. Fatala Chabén; Administración Nacional de Laboratorios e Institutos de Salud Carlos G. Malbrán (ANLIS-Malbrán); Ciudad Autónoma de Buenos Aires, Argentina.
Karenina ScolloInstituto Nacional de Parasitología Dr. M. Fatala Chabén; Administración Nacional de Laboratorios e Institutos de Salud Carlos G. Malbrán (ANLIS-Malbrán); Ciudad Autónoma de Buenos Aires, Argentina.
María BaleaniCentro de Investigación y Biotecnología (CIBIO) de Wiener Laboratorios SAIC, Rosario, Pcia. de Santa Fe, Argentina.
Laura LaraInstituto de Maternidad y Ginecología "Nuestra Señora de las Mercedes", San Miguel de Tucumán, Pcia. de Tucumán, Argentina.
Gustavo AgoltiHospital "Dr. Julio César Perrando", Resistencia, Pcia. de Chaco, Argentina.
Sandra SeuHospital Regional "Dr. Ramón Carrillo", Santiago del Estero, Pcia. de Santiago del Estero, Argentina.
Elsa AdamoCentro Integral de Salud La Banda, La Banda, Pcia. de Santiago del Estero, Argentina.
Raúl Horacio LuceroInstituto de Medicina Regional, Universidad Nacional del Nordeste (IMR-UNNE) Resistencia, Provincia de Chaco, Argentina.
Lucía IrazuDepartamento de Calidad. Administración Nacional de Laboratorios e Institutos de Salud Carlos G. Malbrán (ANLIS-Malbrán).
Marcelo RodriguezDepartamento de Calidad. Administración Nacional de Laboratorios e Institutos de Salud Carlos G. Malbrán (ANLIS-Malbrán).
Andrés Poeylaut-PalenaCentro de Investigación y Biotecnología (CIBIO) de Wiener Laboratorios SAIC, Rosario, Pcia. de Santa Fe, Argentina.
Silvia Andrea LonghiLaboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh) Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr Héctor Torres" (INGEBI) - Consejo Nacional de Investigaciones Científicas y Técnicas, CONICET; Ciudad Autónoma de Buenos Aires, Argentina.
Mónica EstevaInstituto Nacional de Parasitología Dr. M. Fatala Chabén; Administración Nacional de Laboratorios e Institutos de Salud Carlos G. Malbrán (ANLIS-Malbrán); Ciudad Autónoma de Buenos Aires, Argentina.
Fernando AlthabeDepartamento en Salud de la Madre y el Niño, Instituto de Efectividad Clínica y Sanitaria, Ciudad Autónoma de Buenos Aires, Argentina.
Federico RojkinCentro de Investigación y Biotecnología (CIBIO) de Wiener Laboratorios SAIC, Rosario, Pcia. de Santa Fe, Argentina.
Jacqueline BuaInstituto Nacional de Parasitología Dr. M. Fatala Chabén; Administración Nacional de Laboratorios e Institutos de Salud Carlos G. Malbrán (ANLIS-Malbrán); Ciudad Autónoma de Buenos Aires, Argentina.
Sergio Sosa-EstaniDepartamento en Salud de la Madre y el Niño, Instituto de Efectividad Clínica y Sanitaria, Ciudad Autónoma de Buenos Aires, Argentina; Instituto Nacional de Parasitología Dr. M. Fatala Chabén; Administración Nacional de Laboratorios e Institutos de Salud Carlos G. Malbrán (ANLIS-Malbrán); Ciudad Autónoma de Buenos Aires, Argentina.
Alejandro Gabriel SchijmanLaboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh) Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr Héctor Torres" (INGEBI) - Consejo Nacional de Investigaciones Científicas y Técnicas, CONICET; Ciudad Autónoma de Buenos Aires, Argentina. Electronic address: schijman@dna.uba.ar.
Congenital Chagas Disease Study Group
Administración Nacional de Laboratorios e Institutos de Salud · ARInstituto de Biomedicina y Genética Molecular de Valladolid · ESInstitute of Parasitology · CZInstituto de Efectividad Clínica y Sanitaria · ARNational University of Santiago del Estero · ARConsejo Nacional de Investigaciones Científicas y Técnicas · ARNational University of the Northeast · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent algorithm for Congenital Chagas Disease (cCD) diagnosis is unsatisfactory due to low sensitivity of the parasitological methods. Moreover, loss to follow-up precludes final serodiagnosis after nine months of life in many cases. A duplex TaqMan qPCR kit for Trypanosoma cruzi DNA amplification was prospectively evaluated in umbilical cord (UCB) and peripheral venous blood (PVB) of infants born to CD mothers at endemic and non-endemic sites of Argentina.

methodsWe enrolled and followed-up 370 infants; qPCR was compared to gold-standard cCD diagnosis following studies of diagnostic accuracy guidelines.

findingsFourteen infants (3·78%) had cCD. The qPCR sensitivity and specificity were higher in PVB (72·73%, 99·15% respectively) than in UCB (66·67%, 96·3%). Positive and negative predictive values were 80 and 98·73% and 50 and 98·11% for PVB and UCB, respectively. The Areas under the Curve (AUC) of ROC analysis for qPCR and micromethod (MM) were 0·81 and 0·67 in UCB and 0·86 and 0·68 in PVB, respectively. Parasitic loads ranged from 37·5 to 23,709 parasite equivalents/mL. Discrete typing Unit Tc V was identified in five cCD patients and in six other cCD cases no distinction among Tc II, Tc V or Tc VI was achieved.

interpretationThis first prospective field study demonstrated that qPCR was more sensitive than MM for early cCD detection and more accurate in PVB than in UCB. Its use, as an auxiliary diagnostic tool to MM will provide more accurate records on cCD incidence.

fundingFITS SALUD 001-CHAGAS (FONARSEC, MINCyT, Argentina) to the Public-Private Consortium (INGEBI-CONICET, INP-ANLIS MALBRAN and Wiener Laboratories); ERANET-LAC-HD 328 to AGS and PICT 2015-0074 (FONCYT, MinCyT) to AGS and FA.

Indexed as

AdultChagas DiseaseEarly DiagnosisFemaleHumansInfant, NewbornMaleReagent Kits, DiagnosticReal-Time Polymerase Chain ReactionSensitivity and SpecificityReagent Kits, DiagnosticCongenital Chagas diseaseDiscrete typing unitEarly diagnosisParasitic loadReal Time PCRTrypanosoma cruzi

Identifiers

PMID34186488
PMCPMC8243352
OpenAlexW3177024593

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.