Evidence map›Paper›PMID 25253664›Full record

ArticleClinical and vaccine immunology : CVI2014

Inter- and intralaboratory comparison of JC polyomavirus antibody testing using two different virus-like particle-based assays.

Piotr Kardas, Mohammadreza Sadeghi, Fabian H Weissbach, Tingting Chen, Lea Hedman, Eeva Auvinen, Klaus Hedman, Hans H Hirsch

Open access · diamondAbstract readEvaluation Study
In one paragraph

Article in Clinical and vaccine immunology : CVI, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.3field-weighted citation impact, top 18% 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

10 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Characterization of Immunodominant BK Polyomavirus 9mer Epitope T Cell Responses.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2016
    Article
  6. BK Polyomavirus Replication in Renal Tubular Epithelial Cells Is Inhibited by Sirolimus, but Activated by Tacrolimus Through a Pathway Involving FKBP-12.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2016
    Article
  7. Article
  8. Article
  9. Observational
  10. 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 4 institutions in 2 countries.

Piotr KardasTransplantation and Clinical Virology, Department Biomedicine (Haus Petersplatz), University of Basel, Basel, Switzerland.
Mohammadreza SadeghiDepartment of Virology, Haartman Institute, University of Helsinki, Helsinki, Finland.
Fabian H WeissbachTransplantation and Clinical Virology, Department Biomedicine (Haus Petersplatz), University of Basel, Basel, Switzerland.
Tingting ChenDepartment of Virology, Haartman Institute, University of Helsinki, Helsinki, Finland.
Lea HedmanDepartment of Virology, Haartman Institute, University of Helsinki, Helsinki, Finland Department of Virology and Immunology, Helsinki University Central Hospital Laboratory Services, Helsinki, Finland.
Eeva AuvinenDepartment of Virology, Haartman Institute, University of Helsinki, Helsinki, Finland Department of Virology and Immunology, Helsinki University Central Hospital Laboratory Services, Helsinki, Finland.
Klaus HedmanDepartment of Virology, Haartman Institute, University of Helsinki, Helsinki, Finland Department of Virology and Immunology, Helsinki University Central Hospital Laboratory Services, Helsinki, Finland.
Hans H HirschTransplantation and Clinical Virology, Department Biomedicine (Haus Petersplatz), University of Basel, Basel, Switzerland Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland Division of Infection Diagnostics, Department Biomedicine (Haus Petersplatz), University of Basel, Switzerland hans.hirsch@unibas.ch.
University of Helsinki · FIHelsinki University Hospital · FIUniversity of Basel · CHUniversity Hospital of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

JC polyomavirus (JCPyV) can cause progressive multifocal leukoencephalopathy (PML), a debilitating, often fatal brain disease in immunocompromised patients. JCPyV-seropositive multiple sclerosis (MS) patients treated with natalizumab have a 2- to 10-fold increased risk of developing PML. Therefore, JCPyV serology has been recommended for PML risk stratification. However, different antibody tests may not be equivalent. To study intra- and interlaboratory variability, sera from 398 healthy blood donors were compared in 4 independent enzyme-linked immunoassay (ELISA) measurements generating >1,592 data points. Three data sets (Basel1, Basel2, and Basel3) used the same basic protocol but different JCPyV virus-like particle (VLP) preparations and introduced normalization to a reference serum. The data sets were also compared with an independent method using biotinylated VLPs (Helsinki1). VLP preadsorption reducing ≥35% activity was used to identify seropositive sera. The results indicated that Basel1, Basel2, Basel3, and Helsinki1 were similar regarding overall data distribution (P = 0.79) and seroprevalence (58.0, 54.5, 54.8, and 53.5%, respectively; P = 0.95). However, intra-assay intralaboratory comparison yielded 3.7% to 12% discordant results, most of which were close to the cutoff (0.080 < optical density [OD] < 0.250) according to Bland-Altman analysis. Introduction of normalization improved overall performance and reduced discordance. The interlaboratory interassay comparison between Basel3 and Helsinki1 revealed only 15 discordant results, 14 (93%) of which were close to the cutoff. Preadsorption identified specificities of 99.44% and 97.78% and sensitivities of 99.54% and 95.87% for Basel3 and Helsinki1, respectively. Thus, normalization to a preferably WHO-approved reference serum, duplicate testing, and preadsorption for samples around the cutoff may be necessary for reliable JCPyV serology and PML risk stratification.

Indexed as

Antigens, ViralVirosomesAntibodies, ViralEnzyme-Linked Immunosorbent AssayHumansJC VirusLeukoencephalopathy, Progressive MultifocalPolyomavirus InfectionsReproducibility of ResultsSensitivity and SpecificityAntibodies, ViralAntigens, ViralVirosomes

Identifiers

PMID25253664
PMCPMC4248761
OpenAlexW2141469907

What OpenQuestion holds

Textmetadata
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.