Evidence map›Paper›PMID 26013970›Full record

ArticleTransfusion2015

Sensitivity of hepatitis C virus core antigen and antibody combination assays in a global panel of window period samples.

Syria Laperche, C Micha Nübling, Susan L Stramer, Ewa Brojer, Piotr Grabarczyk, Hiroshi Yoshizawa, Vytenis Kalibatas, Magdy El Elkyabi, Faten Moftah, Annie Girault and 3 more

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Transfusion, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Performance of ElecsysDiagnostics (Basel, Switzerland) · 2024
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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

13 authors.

Syria LapercheInstitut National de la Transfusion Sanguine (INTS), Département d'Études des Agents Transmissibles par le Sang, Centre National de Reference pour les Hepatites B et C en Transfusion, F-75015 Paris, France.
C Micha NüblingSection of Molecular Virology, Paul Ehrlich Institute, Langen, Germany.
Susan L StramerScientific Support Office, American Red Cross, Gaithersburg, Maryland.
Ewa BrojerInstitute of Haematology and Transfusion Medicine, Warsaw, Poland.
Piotr GrabarczykInstitute of Haematology and Transfusion Medicine, Warsaw, Poland.
Hiroshi YoshizawaStudy Group of NAT Standardization under the Ministry of Health, Labor and Welfare of Japan (2001-2003), Tokyo, Japan.
Vytenis KalibatasNacionalinis Kraujo Centras, Vilnius, Lithuania.
Magdy El ElkyabiShabrawishi Hospital, Cairo, Egypt.
Faten MoftahShabrawishi Hospital, Cairo, Egypt.
Annie GiraultInstitut National de la Transfusion Sanguine (INTS), Département d'Études des Agents Transmissibles par le Sang, Centre National de Reference pour les Hepatites B et C en Transfusion, F-75015 Paris, France.
Harry van DrimmelenBiologicals Quality Control, Rijswijk, the Netherlands.
Michael P BuschBlood Systems Research Institute, San Francisco, California.
Nico LelieLelie Research, Paris, France.

Funding

UCSF Liver Core CenterP30DK026743 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Holger Willenbring · 1986 to 2026
$30.7M
NIDDK NIH HHS P30 DK026743
6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV) antigen and antibody combination assays have been launched as a cost-effective alternative to nucleic acid testing (NAT) for reducing the antibody-negative window period (WP). Later, a HCV antigen chemiluminescence immunoassay (CLIA) became available. STUDY DESIGN AND

methodsA panel composed of 337 HCV NAT-yield samples that were characterized for viral load (VL) and genotype was used to compare the sensitivity of two combination enzyme-linked immunosorbent assays (Monolisa, Bio-Rad; and Murex, formerly Abbott) and a HCV antigen CLIA (Abbott). Analytic sensitivity was compared with HCV RNA detection using Ultrio (Grifols) by testing serial dilutions of 10 genotype (gt)1 to gt4 samples.

resultsHCV antigen CLIA detected 92.4% of samples, whereas Monolisa and Murex detected 38.3 and 47.5%, respectively. In the HCV RNA VL range of 10(5) to 10(7) IU/mL, Monolisa and Murex detected 38% to 56% of gt1, 85% to 78% of gt2, and 21% to 37% of gt3. The overall geometric mean 50% limit of detection (range) of Ultrio on gt1 to gt4 dilution series was 3.5 (1.2-7.7) copies/mL, compared to 3.3 × 10(6) (4.4 × 10(5) -2.7 × 10(7) ), 3.4 × 10(6) (2.2 × 10(5) -4.2 × 10(7) ), and 2728 (415-7243) copies/mL for Monolisa, Murex, and HCV antigen CLIA, respectively.

conclusionAnalytical sensitivity of NAT was on average 1 million- and 780-fold higher than combination assays and HCV antigen CLIA, respectively. Relative sensitivities of combination assays differed for genotypes with Murex being more sensitive for gt1 and gt3 and Monolisa more sensitive for gt2. Although being less sensitive than NAT, combination assays could be considered in resource-limited settings since they detect 38% to 47% of seronegative WP donations.

Indexed as

HepacivirusLuminescent MeasurementsFemaleHepatitis CHepatitis C AntibodiesHepatitis C AntigensHumansMaleNucleic Acid Amplification TechniquesRNA, ViralSensitivity and SpecificityHepatitis C AntibodiesHepatitis C AntigensRNA, Viral

Identifiers

PMID26013970
PMCPMC4744653

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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.