Evidence map›Paper›PMID 39713195›Full record

ArticleGlobal heart2024

Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device.

Fabio Grunspun Pitta, Adriana Caschera Leme, Simone Rodrigues Gomes, Tarsila Perez Mota, Fernanda Vieira Paladino, José Leão de Souza Júnior, Rosemeire de Paula Braz, Thais Cristine Rodrigues Leonel Lamounier, Jéssica Buzin Gomes Ferreira, Carlos Eduardo Dos Santos Ferreira

Abstract readValidation Study
In one paragraph

Article in Global heart, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Wearable Flexible Sensors for Cardiovascular Disease Monitoring.Advanced materials (Deerfield Beach, Fla.) · 2026
    Review
  2. Review
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

10 authors.

Fabio Grunspun PittaHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo - SP, Brazil.ORCID 0000-0001-7574-757X
Adriana Caschera LemeHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo - SP, Brazil.ORCID 0009-0000-7911-9589
Simone Rodrigues GomesHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo - SP, Brazil.ORCID 0009-0001-2519-5882
Tarsila Perez MotaHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo - SP, Brazil.ORCID 0000-0001-7179-7350
Fernanda Vieira PaladinoHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo - SP, Brazil.ORCID 0000-0003-0785-970X
José Leão de Souza JúniorHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo - SP, Brazil.ORCID 0009-0002-6393-3046
Rosemeire de Paula BrazSiemens Healthcare Diagnósticos S.A, São Paulo - SP, Brazil.ORCID 0009-0005-4731-7982
Thais Cristine Rodrigues Leonel LamounierSiemens Healthcare Diagnósticos S.A, São Paulo - SP, Brazil.ORCID 0009-0005-1304-260X
Jéssica Buzin Gomes FerreiraSiemens Healthcare Diagnósticos S.A, São Paulo - SP, Brazil.ORCID 0009-0006-8137-3491
Carlos Eduardo Dos Santos FerreiraHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo - SP, Brazil.ORCID 0000-0001-9149-1252

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In Acute Coronary Syndrome without ST-segment elevation, the use of high-sensitivity troponins in rapid protocols is considered the gold standard for diagnostic exclusion/confirmation, in conjunction with clinical stratification. The biggest concern regarding the techniques for troponin evaluation is the time required between collection and delivery of the result. Objective: The objective of the present study is the clinical/laboratory validation of a POCT device for TnI. Methods: In the first phase of the study, samples from 108 patients with known troponin values High Sensitivity Automated Troponin T (TnT) assay from Results: There was a correlation between the POCT Atellica® vTLi and hs-cTnT Cobas® in the serum samples of the control group (r = 0.660, p < 0.0001). Besides, there was a correlation between the Atellica® vTLi, serum hs-cTnT Cobas®, plasma hs-cTnT Cobas®, serum Atellica IM and plasma Atellica IM 1300 platforms in the second phase (p < 0.0001 in all cases). Conclusion: In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Given these results, the device can be used in institutions that intend to use a POCT device for 0- and 1-hour chest pain protocols.

Indexed as

Acute Coronary SyndromePoint-of-Care TestingTroponin IAgedBiomarkersFemaleHumansMaleMiddle AgedProspective StudiesReproducibility of ResultsBiomarkersTroponin IAcute Coronary Syndromechest painpoint-of-caretroponin

Identifiers

PMID39713195
PMCPMC11661013

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.