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...
Main Authors: | , , , , , , , , |
---|---|
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 |
_version_ | 1818026512761225216 |
---|---|
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. |
first_indexed | 2024-12-10T04:33:11Z |
format | Article |
id | doaj.art-9a4c52aae10043ddbf841d379bc81ee1 |
institution | Directory Open Access Journal |
issn | 1935-2727 1935-2735 |
language | English |
last_indexed | 2024-12-10T04:33:11Z |
publishDate | 2016-06-01 |
publisher | Public Library of Science (PLoS) |
record_format | Article |
series | PLoS Neglected Tropical Diseases |
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 |
work_keys_str_mv | AT elisaeggerbauer evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT paoladebenedictis evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT berndhoffmann evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT thomascmettenleiter evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT koreschlottau evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT ernestcngoepe evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT claudetsabeta evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT conradmfreuling evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial AT thomasmuller evaluationofsixcommerciallyavailablerapidimmunochromatographictestsforthediagnosisofrabiesinbrainmaterial |