Evidence map›Paper›PMID 30949310›Full record

ReviewJournal of extracellular vesicles2019

Clinical requirements for extracellular vesicle assays.

Lisa Ayers, Ryan Pink, David Raul Francisco Carter, Rienk Nieuwland

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of extracellular vesicles, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 1 pooled it
–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

63 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Diagnostic value of exosomes in patients with liver cancer: a systematic review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
    Pooled it
  2. PSMA+ Extracellular Vesicles Are a Biomarker for SABR in Oligorecurrent Prostate Cancer: Analysis from the STOMP-like and ORIOLE Trial Cohorts.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
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3 more citing papers are in PubMed but not listed here.

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

4 authors.

Lisa AyersDepartment of Clinical and Laboratory Immunology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Ryan PinkDepartment of Biological and Medical Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.
David Raul Francisco CarterDepartment of Biological and Medical Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.
Rienk NieuwlandLaboratory of Experimental Clinical Chemistry, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Funding

Department of Health NIHR-HCS-P13-04-001
6 · The paper itself

Abstract

The scientific and clinical interest in extracellular vesicles (EV) has grown exponentially during the past 15 years. As most research indicates that EVs can be utilised in diagnostics, prognostics and therapeutics, we may be on the brink of establishing the clinical utility of EV measurement, but how can we make this a reality? If we are to introduce EVs as biomarkers into clinical laboratories, it will be necessary to offer fully validated, International Organization for Standardization (ISO) standard 15189 assays. ISO 15189 defines the quality management system requirements particular to medical laboratories and is used internationally to determine accreditation. In order for a clinical laboratory to offer an accredited test for EVs, this assay must have been subjected to a thorough assay validation process. This process requires the generation of data related to defined performance characteristics, to ensure that an assay is performing in accordance with the needs of its clinical users. Each of the defined performance characteristics will be discussed in this review, along with the issues that specifically affect EV analysis. Accreditation is increasingly important for all clinical laboratories and the standards required to achieve this are becoming more and more stringent. Therefore, as companies seek to develop the best assays to detect EVs and their molecular contents for clinical utility, and as we move rapidly towards our goal of offering EV analysis in the diagnosis and monitoring of disease, it is timely to highlight the requirements for the clinical accreditation of such assays. It is essential to consider these parameters to ensure that we develop the highest quality assays possible and ultimately the best outcomes for patients.

Indexed as

accreditationclinical assaysExtracellular vesiclesISO 15189standardisationvalidationverification

Identifiers

PMID30949310
PMCPMC6442087

What OpenQuestion holds

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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.