Evidence map›Paper›PMID 28468860›Full record

ArticleJournal of clinical microbiology2017

Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan.

Syria Laperche, Silvia Sauleda, Maria Piron, Annelies Mühlbacher, Harald Schennach, Volkmar Schottstedt, Lucinda Queirós, Naoki Uno, Katsunori Yanagihara, Roland Imdahl and 5 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical microbiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.8field-weighted citation impact, top 31% 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

12 citing papers in PubMed, 25 citations in OpenAlex.

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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

15 authors at 9 institutions in 6 countries.

Syria LapercheInstitut National de la Transfusion Sanguine (INTS), Département des agents transmissibles par le sang, Centre National de Référence Risques Infectieux Transfusionnels, Paris, France slaperche@ints.fr.
Silvia SauledaBanc de Sang i Teixits, Barcelona, Spain.
Maria PironBanc de Sang i Teixits, Barcelona, Spain.
Annelies MühlbacherCentral Institute for Blood Transfusion and Immunology, University Hospital, Innsbruck, Austria.
Harald SchennachCentral Institute for Blood Transfusion and Immunology, University Hospital, Innsbruck, Austria.
Volkmar SchottstedtDRK Blutspendedienst West Central Laboratory, Hagen, Germany.
Lucinda QueirósInstituto Português do Sangue e da Transplantação, Porto, Portugal.
Naoki UnoDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.
Katsunori YanagiharaDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.
Roland ImdahlLabor Schottdorf MVZ, Augsburg, Germany.
Ariann HeyLabor Schottdorf MVZ, Augsburg, Germany.
Markus KlinkichtRoche Diagnostics, Penzberg, Germany.
Walter MelchiorRoche Diagnostics, Penzberg, Germany.
Peter MuenchRoche Diagnostics, Penzberg, Germany.
Toshiki WatanabeGraduate School of Frontier Sciences, University of Tokyo, Tokyo, Japan.
Roche Pharma AG (Germany) · DEBanc de Sang i Teixits · ESNagasaki University Hospital · JPSchott (Germany) · DEUniversity Hospital Innsbruck · ATDRK-Blutspendedienst Baden-Württemberg - Hessen · DEInstitut National de la Transfusion Sanguine · FRInstituto Portugues do Sangue e da Transplantacao, IPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Screening of blood for human T-cell lymphotropic virus type 1 and type 2 (HTLV-1 and -2, respectively) is important to diagnose and prevent infection and ensure the safety of blood supplies. The Elecsys HTLV-I/II assay is a newly developed, electrochemiluminescence screening assay for the detection of HTLV-1/2 infection. The sensitivity and specificity of the Elecsys HTLV-I/II assay were determined using well-characterized HTLV-1/2-positive serum and plasma samples and routine diagnostic and blood donor samples expected to be HTLV negative, respectively. These results were compared with those for at least one of the following CE-marked assays at seven independent laboratories and the Roche Diagnostics facility in Penzberg, Germany: Abbott Architect rHTLV-I/II, Ortho Avioq HTLV-I/II Microelisa system, Abbott Prism HTLV-I/HTLV-II, and DiaSorin Murex HTLV I+II. Fujirebio INNO-LIA HTLV-I/II Score was used as a confirmatory assay. The Elecsys HTLV-I/II, Abbott Architect rHTLV-I/II, and Abbott Prism HTLV-I/HTLV-II assays detected all HTLV-1/2-positive samples (sensitivity, 100%). Sensitivity for Ortho Avioq HTLV-I/II was 98.63%. The Elecsys HTLV-I/II assay had a specificity of 99.95% in blood donor samples, which was comparable to results for the other assays (range, 99.91 to 100%). In routine diagnostic samples, the specificity of the Elecsys HTLV-I/II assay was 99.83%, compared with 99.70% for Abbott Architect rHTLV-I/II. Specificity for the Elecsys HTLV-I/II assay in potentially cross-reactive samples was 100%, compared with 99.0% for Ortho Avioq HTLV-I/II and 99.2% for DiaSorin Murex HTLV I+II. The Elecsys HTLV-I/II assay has the sensitivity and specificity to support its use as a routine screening assay for detecting HTLV infection.

Indexed as

BloodEuropeHTLV-II InfectionsHTLV-I InfectionsHumansHuman T-lymphotropic virus 1Human T-lymphotropic virus 2JapanLuminescent MeasurementsMass ScreeningSensitivity and Specificityblood screeningdiagnosisElecsyselectrochemiluminescenceHTLV-1HTLV-2immunoassayssensitivityspecificity

Identifiers

PMID28468860
PMCPMC5483920
OpenAlexW2610991674

What OpenQuestion holds

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LicenceCC BY
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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.