Evidence map›Paper›PMID 26423888›Full record

ArticleBMC infectious diseases2015

Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA: an international inter-laboratory assessment.

Eshan U Patel, Jordyn Manucci, Erin M Kahle, Jairam R Lingappa, Rhoda Ashley Morrow, Estelle Piwowar-Manning, Anelet James, Kwitaka F Maluzi, Maina M Cheeba, Glenda Gray and 6 more

Erratum issuedAbstract readEvaluation Study
In one paragraph

Article in BMC infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Eshan U PatelLaboratory of Immunoregulation, Division of Intramural Research, NIAID, NIH, Baltimore, MD, USA.
Jordyn ManucciDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Erin M KahleDepartment of Epidemiology, University of Washington, Seattle, WA, USA.
Jairam R LingappaDepartments of Medicine, Global Health, and Pediatrics, University of Washington, Seattle, WA, USA.
Rhoda Ashley MorrowDepartment of Laboratory Medicine, University of Washington, Seattle, WA, USA.
Estelle Piwowar-ManningDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Anelet JamesDepartment of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.
Kwitaka F MaluziZambart, Lusaka, Zambia.
Maina M CheebaZambart, Lusaka, Zambia.
Glenda GrayPerinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Barry Kosloff
Sinead Delany-MoretlweWits Reproductive Health and HIV Institute and University of the Witwatersrand, Johannesburg, South Africa.
Mubiana InambaoZambia-Emory Research Project and Ndola Central Hospital, Ndola, Zambia.
Bellington VwalikaZambia-Emory Research Project, Lusaka, Zambia.
Thomas C QuinnLaboratory of Immunoregulation, Division of Intramural Research, NIAID, NIH, Baltimore, MD, USA.
Oliver LaeyendeckerLaboratory of Immunoregulation, Division of Intramural Research, NIAID, NIH, Baltimore, MD, USA. olaeyen1@jhmi.edu.

Funding

LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
THE PERINATAL COMPLICATIONS OF ASYMPTOMATIC GENITAL HERPES SIMPLEX VIRUSP01AI030731 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 1991 to 2017
$34.3M
International Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8M
Immunopathogenesis Of Chlamydia trachomatis InfectionZIAAI000358 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI QUINN, THOMAS · 2009 to 2022
$7.0M
NIAID NIH HHS P01 AI030731NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1AI068613
6 · The paper itself

Abstract

backgroundThe commercial Kalon HSV-2 IgG ELISA is currently recommended for research use in sub-Saharan Africa because of its superior accuracy compared to other serologic assays. However, there are no data on key precision parameters of Kalon such as inter-operator variation, repeatability, and reproducibility, thus contributing to a barrier for its acceptance and use in clinical trials in sub-Saharan Africa. We evaluated the analytical and field precision of the Kalon HSV-2 IgG ELISA.

methodsA total of 600 HIV-infected and uninfected serum samples from South Africa and Zambia, previously tested by the gold standard University of Washington HSV western blot (UW-WB), were tested using Kalon by two technologists in an United States reference laboratory. Aliquots of 183 samples were retested using Kalon by an on-site technologist in a South African laboratory and a Zambian laboratory.

resultsIntra-assay variation was below 10 %. Intra-assay, intra-laboratory, and inter-laboratory correlation and agreement were significantly high (p < 0.01). In comparison to the UW-WB, accurate performance of Kalon was reproducible by each operator and laboratory. Receiver operating characteristic curve analysis indicated high selectivity of Kalon in the overall study population (area under the curve = 0.95, 95%CI = 0.92-0.97). DISCUSSION: Kalon is a robust assay with high precision and reproducibility. Accordingly, operator errorlikely does not contribute to the variability observed in Kalon's specificity throughout sera from sub-Saharan Africa.

conclusionsIn populations with optimal diagnostic accuracy, Kalon is a reliable stand-alone method for on-site HSV-2 IgG antibody detection.

Indexed as

Enzyme-Linked Immunosorbent AssayAdultAntibodies, ViralArea Under CurveCalibrationFemaleHerpes GenitalisHerpesvirus 2, HumanHIV InfectionsHumansImmunoglobulin GLaboratoriesMaleReproducibility of ResultsROC CurveSensitivity and SpecificityAntibodies, ViralImmunoglobulin G

Identifiers

PMID26423888
PMCPMC4591065

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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.