Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.

Rabies is a neglected zoonotic disease that causes an estimated 60,000 human deaths annually. The main burden lies on developing countries in Asia and Africa, where surveillance and disease detection is hampered by absence of adequate laboratory facilities and/or the difficulties of submitting sampl...

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Main Authors: Elisa Eggerbauer, Paola de Benedictis, Bernd Hoffmann, Thomas C Mettenleiter, Kore Schlottau, Ernest C Ngoepe, Claude T Sabeta, Conrad M Freuling, Thomas Müller
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2016-06-01
Series:PLoS Neglected Tropical Diseases
Online Access:http://europepmc.org/articles/PMC4918935?pdf=render
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author Elisa Eggerbauer
Paola de Benedictis
Bernd Hoffmann
Thomas C Mettenleiter
Kore Schlottau
Ernest C Ngoepe
Claude T Sabeta
Conrad M Freuling
Thomas Müller
author_facet Elisa Eggerbauer
Paola de Benedictis
Bernd Hoffmann
Thomas C Mettenleiter
Kore Schlottau
Ernest C Ngoepe
Claude T Sabeta
Conrad M Freuling
Thomas Müller
author_sort Elisa Eggerbauer
collection DOAJ
description Rabies is a neglected zoonotic disease that causes an estimated 60,000 human deaths annually. The main burden lies on developing countries in Asia and Africa, where surveillance and disease detection is hampered by absence of adequate laboratory facilities and/or the difficulties of submitting samples from remote areas to laboratories. Under these conditions, easy-to-use tests such as immunochromatographic assays, i.e. lateral flow devices (LFD), may increase surveillance and improve control efforts. Several LFDs for rabies diagnosis are available but, except for one, there are no data regarding their performance. Therefore, we compared six commercially available LFDs for diagnostic and analytical sensitivity, as well as their specificity and their diagnostic agreement with standard rabies diagnostic techniques using different sample sets, including experimentally infected animals and several sets of field samples. Using field samples the sensitivities ranged between 0% up to 100% depending on the LFD and the samples, while for experimentally infected animals the maximum sensitivity was 32%. Positive results in LFD could be further validated using RT-qPCR and sequencing. In summary, in our study none of the tests investigated proved to be satisfactory, although the results somewhat contradict previous studies, indicating batch to batch variation. The high number of false negative results reiterates the necessity to perform a proper test validation before being marketed and used in the field. In this respect, marketing authorization and batch release control could secure a sufficient quality for these alternative tests, which could then fulfil their potential.
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spelling doaj.art-9a4c52aae10043ddbf841d379bc81ee12022-12-22T02:02:05ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352016-06-01106e000477610.1371/journal.pntd.0004776Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.Elisa EggerbauerPaola de BenedictisBernd HoffmannThomas C MettenleiterKore SchlottauErnest C NgoepeClaude T SabetaConrad M FreulingThomas MüllerRabies is a neglected zoonotic disease that causes an estimated 60,000 human deaths annually. The main burden lies on developing countries in Asia and Africa, where surveillance and disease detection is hampered by absence of adequate laboratory facilities and/or the difficulties of submitting samples from remote areas to laboratories. Under these conditions, easy-to-use tests such as immunochromatographic assays, i.e. lateral flow devices (LFD), may increase surveillance and improve control efforts. Several LFDs for rabies diagnosis are available but, except for one, there are no data regarding their performance. Therefore, we compared six commercially available LFDs for diagnostic and analytical sensitivity, as well as their specificity and their diagnostic agreement with standard rabies diagnostic techniques using different sample sets, including experimentally infected animals and several sets of field samples. Using field samples the sensitivities ranged between 0% up to 100% depending on the LFD and the samples, while for experimentally infected animals the maximum sensitivity was 32%. Positive results in LFD could be further validated using RT-qPCR and sequencing. In summary, in our study none of the tests investigated proved to be satisfactory, although the results somewhat contradict previous studies, indicating batch to batch variation. The high number of false negative results reiterates the necessity to perform a proper test validation before being marketed and used in the field. In this respect, marketing authorization and batch release control could secure a sufficient quality for these alternative tests, which could then fulfil their potential.http://europepmc.org/articles/PMC4918935?pdf=render
spellingShingle Elisa Eggerbauer
Paola de Benedictis
Bernd Hoffmann
Thomas C Mettenleiter
Kore Schlottau
Ernest C Ngoepe
Claude T Sabeta
Conrad M Freuling
Thomas Müller
Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.
PLoS Neglected Tropical Diseases
title Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.
title_full Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.
title_fullStr Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.
title_full_unstemmed Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.
title_short Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.
title_sort evaluation of six commercially available rapid immunochromatographic tests for the diagnosis of rabies in brain material
url http://europepmc.org/articles/PMC4918935?pdf=render
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