Evidence map›Paper›PMID 39682591›Full record

ArticleDiagnostics (Basel, Switzerland)2024

A Comprehensive Clinical Assessment of the LumiraDx International Normalized Ratio (INR) Assay for Point-of-Care Monitoring in Anticoagulation Therapy.

Riffat Munir, Elise Schapkaitz, Lara Noble, Sakina Loonat, Melanie McCree, Nazeer Ali, Barry Jacobson, Wendy Susan Stevens, Lesley Erica Scott

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diagnostics (Basel, Switzerland), 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. 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

9 authors.

Riffat MunirWits Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2193, South Africa.ORCID 0000-0001-5007-5295
Elise SchapkaitzHaematology Department, University of the Witwatersrand and the National Health Laboratory Services, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg 2193, South Africa.ORCID 0000-0002-1534-2930
Lara NobleWits Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2193, South Africa.ORCID 0000-0002-4661-9023
Sakina LoonatHaematology Department, University of the Witwatersrand and the National Health Laboratory Services, Chris Hani Baragwanath Academic Hospital, Johannesburg 1864, South Africa.
Melanie McCreeHaematology Department, University of the Witwatersrand and the National Health Laboratory Services, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg 2193, South Africa.ORCID 0000-0001-9317-7435
Nazeer AliHaematology Department, University of the Witwatersrand and the National Health Laboratory Services, Chris Hani Baragwanath Academic Hospital, Johannesburg 1864, South Africa.
Barry JacobsonHaematology Department, University of the Witwatersrand and the National Health Laboratory Services, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg 2193, South Africa.
Wendy Susan StevensWits Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2193, South Africa.
Lesley Erica ScottWits Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2193, South Africa.

Funding

Bill and Melinda Gates Foundation INV006726Gates Foundation INV-006726
6 · The paper itself

Abstract

backgroundThe International Normalized Ratio (INR) monitors anticoagulant treatment but relies on laboratory-based services. This could limit access to rapid monitoring and increase the diagnostic delay, both of which may be addressed by point-of-care testing (POCT). This study investigated the LumiraDx POC platform for INR monitoring.

methodsINR was measured on recalcified residual venous (

resultsThe precision was within the manufacturer's claim for controls (level 1%CV: 3.63, level 2%CV: 2.24). Accuracy analysis showed a moderate overall agreement compared to the SOC INR results with a correlation coefficient of 0.94 (95% Cl, (0.9267 to 0.9497)). The overall precision (ρ > 0.9) and accuracy (C

conclusionThe LumiraDx INR Test showed a good performance compared to laboratory-based testing and provided opportunity for rapid and patient-centric care. Owing to an increasing positive bias for INR > 3.5, confirmation with laboratory INR measurements may be required.

Indexed as

comparative studyinternational normalized ratioLumiraDx Platformpoint of carestandard of carewarfarin

Identifiers

PMID39682591
PMCPMC11639838

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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.