Evidence map›Paper›PMID 37967836›Full record

ArticleSeminars in thrombosis and hemostasis2024

International Council for Standardization in Haematology Guidance for New Lot Verification of Coagulation Reagents, Calibrators, and Controls.

Robert C Gosselin, Donna Castellone, Akbar Dorgalaleh, Kieron Hickey, Giuseppe Lippi, Karen Moffat, Rebecca O'Toole, Joe Rigano

Open access · hybridAbstract read
In one paragraph

Article in Seminars in thrombosis and hemostasis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 20% 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

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. 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

8 authors at 7 institutions in 6 countries.

Robert C GosselinCLS Hemostasis and Thrombosis Center, University of California, Davis Health System, Sacramento, California.ORCID 0000-0002-5669-8722
Donna CastelloneNew York Presbyterian Hospital-Columbia, New York, New York.ORCID 0000-0003-4248-8115
Akbar DorgalalehHamin Pazhuhan Tis Institute, Tehran, Iran.ORCID 0000-0002-0125-9319
Kieron HickeySheffield Laboratory Medicine, Royal Hallamshire Hospital, Sheffield, United Kingdom.
Giuseppe LippiSection of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy.ORCID 0000-0001-9523-9054
Karen MoffatDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton Ontario, Canada.ORCID 0000-0002-6431-5525
Rebecca O'TooleHematology Department, Wellington Hospital and Health Care, Wellington, New Zealand.
Joe RiganoCCS Northern Pathology Victoria, Melbourne, Australia.ORCID 0000-0002-6313-2938
McMaster University · CANewYork–Presbyterian Hospital · USNorthern Health · AURoyal Hallamshire Hospital · GBUC Davis Health · USUniversity of Verona · ITWellington Hospital · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The clinical laboratory uses commercial products with limited shelf life or certain expiry dates requiring frequent lot changes. Prior to implementation for clinical use, laboratories should determine the performance of the new reagent lot to ensure that there is no significant shift in reagent performance or reporting of patient data. This guideline has been written on behalf of the International Council for Standardization in Haematology (ICSH) to provide the framework and provisional guidance for clinical laboratories for evaluating and verifying the performance of new lot reagents used for coagulation testing. These ICSH Working Party consensus recommendations are based on good laboratory practice, regulatory recommendations, evidence emerged from scientific publications, and expert opinion and are meant to supplement regional standards, regulations, or requirements.

Indexed as

Indicators and ReagentsBlood Coagulation TestsCalibrationHematologyHumansReference StandardsIndicators and Reagents

Identifiers

PMID37967836
PMCPMC11469916
OpenAlexW4388714443

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.