Evidence map›Paper›PMID 28835775›Full record

ArticleTherapeutic advances in gastroenterology2017

Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study.

Benjamin Maasoumy, Birgit Bremer, Patrick Lehmann, Ed G Marins, Véronique Michel-Treil, Christian O Simon, Merlin Njoya, Markus Cornberg, Ellen Paxinos, Michael P Manns and 5 more

Open access · hybridAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.6field-weighted citation impact, top 17% 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

3 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
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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 6 institutions in 3 countries.

Benjamin MaasoumyDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany.
Birgit BremerHannover Medical School, Hanover, Germany.
Patrick LehmannHannover Medical School, Hanover, Germany.
Ed G MarinsRoche Molecular Systems Inc., Roche Diagnostics, Pleasanton, CA, USA.
Véronique Michel-TreilCovance Central Laboratory Services SA, Geneva, Switzerland.
Christian O SimonRoche Molecular Systems Inc., Roche Diagnostics, Pleasanton, CA, USA.
Merlin NjoyaRoche Molecular Systems Inc., Roche Diagnostics, Pleasanton, CA, USA.
Markus CornbergHannover Medical School, Hanover, Germany.
Ellen PaxinosRoche Molecular Systems Inc., Roche Diagnostics, Pleasanton, CA, USA.
Michael P MannsHannover Medical School, Hanover, Germany.
Johannes VermehrenUniversity Hospital, Frankfurt, Frankfurt am Main, Germany.
Christoph SarrazinUniversity Hospital, Frankfurt, Frankfurt am Main, Germany.
Ji Yeon SohnDepartment of Laboratory Medicine, National Cancer Center, Goyang, Republic of Korea.
Yunjung ChoKorea University College of Medicine, Seoul, Republic of Korea.
Heiner WedemeyerHannover Medical School, Hanover, Germany.
Medizinische Hochschule Hannover · DERoche (United States) · USGoethe University Frankfurt · DEKorea University · KRNational Cancer Center · KRUniversity Hospital Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHBV DNA is the most important molecular marker in hepatitis B, used to determine treatment indication and monitoring. Most patients require lifelong hepatitis B virus (HBV) management, thus viral load (VL) monitoring may be performed at different laboratories, with different HBV assays, which may result in different VL results. This multicenter study compares the commutability and concordance of results from four different HBV DNA assays: CAP/CTM HBVv2, HPS/CTM HBVv2 and the new cobas 6800/8800 HBV and cobas 4800 HBV assays.

methodsAcross all four assays, HBV limit of detection (LoD) and linearity at lower concentrations were assessed using panels traceable to the World Health Organization international standard, and concordance was investigated at the important medical decision cutoffs 2000 and 20,000 IU/ml, using specimens from HBV-positive patients.

resultsThe calculated LoD

conclusionsThe new cobas 6800/8800 HBV and 4800 HBV assays show high accuracy in samples with low-level viremia and a high concordance with the established HBV tests, CAP/CTM HBVv2 and HPS/CTM HBVv2, at 2000 and 20,000 IU/ml. Thus, all four HBV assays have high commutability and may be used interchangeably in routine clinical practice.

Indexed as

cobasHBV diagnosticsHBV DNA assayHBV treatmenthepatitis B virus

Identifiers

PMID28835775
PMCPMC5557192
OpenAlexW2743576957

What OpenQuestion holds

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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.