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Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border

Rotavirus commonly causes diarrhea in children, leading to hospitalization and even death. Rapid diagnostic tests are feasible alternatives for determining rotavirus outbreaks in refugee camps that have inadequate laboratory capacity. We evaluated the field performance of ImmunoCard STAT!(®) Rotavir...

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Autores principales: Ope, Maurice, Nyoka, Raymond, Unshur, Ahmed, Oyier, Fredrick O., Mowlid, Shafe A., Owino, Brian, Ochieng, Steve B., Okello, Charles I., Montgomery, Joel M., Wagacha, Burton, Galev, Aleksandar, Abdow, Abdikadir, Esona, Mathew D., Tate, Jacqueline, Fitter, David, Cookson, Susan T., Arunmozhi, Balajee, Marano, Nina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The American Society of Tropical Medicine and Hygiene 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5462563/
https://www.ncbi.nlm.nih.gov/pubmed/28719278
http://dx.doi.org/10.4269/ajtmh.16-0885
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author Ope, Maurice
Nyoka, Raymond
Unshur, Ahmed
Oyier, Fredrick O.
Mowlid, Shafe A.
Owino, Brian
Ochieng, Steve B.
Okello, Charles I.
Montgomery, Joel M.
Wagacha, Burton
Galev, Aleksandar
Abdow, Abdikadir
Esona, Mathew D.
Tate, Jacqueline
Fitter, David
Cookson, Susan T.
Arunmozhi, Balajee
Marano, Nina
author_facet Ope, Maurice
Nyoka, Raymond
Unshur, Ahmed
Oyier, Fredrick O.
Mowlid, Shafe A.
Owino, Brian
Ochieng, Steve B.
Okello, Charles I.
Montgomery, Joel M.
Wagacha, Burton
Galev, Aleksandar
Abdow, Abdikadir
Esona, Mathew D.
Tate, Jacqueline
Fitter, David
Cookson, Susan T.
Arunmozhi, Balajee
Marano, Nina
author_sort Ope, Maurice
collection PubMed
description Rotavirus commonly causes diarrhea in children, leading to hospitalization and even death. Rapid diagnostic tests are feasible alternatives for determining rotavirus outbreaks in refugee camps that have inadequate laboratory capacity. We evaluated the field performance of ImmunoCard STAT!(®) Rotavirus (ICS-RV) in Dadaab Refugee Camp and at the Kenya–Somalia border. From May to December 2014, we prospectively enrolled children aged < 5 years hospitalized with acute diarrhea, defined as ≥ 3 episodes of loose stool in 24 hours for < 7 days. Stool samples were collected and tested by trained surveillance clerks using ICS-RV per manufacturer's instructions. The field performance characteristics of ICS-RV were evaluated against the gold standard test, Premier(™) Rotaclone(®) enzyme immunoassay. The operational characteristics were evaluated using World Health Organization (WHO) ASSURED criteria to determine whether ICS-RV is appropriate as a point-of-care test by administering a standard questionnaire and observing surveillance clerks performing the test. We enrolled 213 patients with a median age of 10 months (range = 1–48); 58.2% were male. A total of 71 (33.3%) and 60 (28.2%) patients tested positive for rotavirus infection by immunoassay and ICS-RV, respectively. The sensitivity, specificity, and positive and negative predictive values of ICS-RV compared with the immunoassay were 83.1% (95% confidence interval [CI] = 72.3–91.0), 99.3% (95% CI = 96.1–100), 98.3% (95% CI = 91.1–100), and 92.1% (95% CI = 86.6–95.5), respectively. The ICS-RV fulfilled the WHO ASSURED criteria for point-of-care testing. ICS-RV is a field-ready point-of-care test with good field performance and operational characteristics. It can be useful in determining rotavirus outbreaks in resource-limited settings.
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spelling pubmed-54625632017-06-14 Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border Ope, Maurice Nyoka, Raymond Unshur, Ahmed Oyier, Fredrick O. Mowlid, Shafe A. Owino, Brian Ochieng, Steve B. Okello, Charles I. Montgomery, Joel M. Wagacha, Burton Galev, Aleksandar Abdow, Abdikadir Esona, Mathew D. Tate, Jacqueline Fitter, David Cookson, Susan T. Arunmozhi, Balajee Marano, Nina Am J Trop Med Hyg Articles Rotavirus commonly causes diarrhea in children, leading to hospitalization and even death. Rapid diagnostic tests are feasible alternatives for determining rotavirus outbreaks in refugee camps that have inadequate laboratory capacity. We evaluated the field performance of ImmunoCard STAT!(®) Rotavirus (ICS-RV) in Dadaab Refugee Camp and at the Kenya–Somalia border. From May to December 2014, we prospectively enrolled children aged < 5 years hospitalized with acute diarrhea, defined as ≥ 3 episodes of loose stool in 24 hours for < 7 days. Stool samples were collected and tested by trained surveillance clerks using ICS-RV per manufacturer's instructions. The field performance characteristics of ICS-RV were evaluated against the gold standard test, Premier(™) Rotaclone(®) enzyme immunoassay. The operational characteristics were evaluated using World Health Organization (WHO) ASSURED criteria to determine whether ICS-RV is appropriate as a point-of-care test by administering a standard questionnaire and observing surveillance clerks performing the test. We enrolled 213 patients with a median age of 10 months (range = 1–48); 58.2% were male. A total of 71 (33.3%) and 60 (28.2%) patients tested positive for rotavirus infection by immunoassay and ICS-RV, respectively. The sensitivity, specificity, and positive and negative predictive values of ICS-RV compared with the immunoassay were 83.1% (95% confidence interval [CI] = 72.3–91.0), 99.3% (95% CI = 96.1–100), 98.3% (95% CI = 91.1–100), and 92.1% (95% CI = 86.6–95.5), respectively. The ICS-RV fulfilled the WHO ASSURED criteria for point-of-care testing. ICS-RV is a field-ready point-of-care test with good field performance and operational characteristics. It can be useful in determining rotavirus outbreaks in resource-limited settings. The American Society of Tropical Medicine and Hygiene 2017-06-07 /pmc/articles/PMC5462563/ /pubmed/28719278 http://dx.doi.org/10.4269/ajtmh.16-0885 Text en ©The American Society of Tropical Medicine and Hygiene This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Articles
Ope, Maurice
Nyoka, Raymond
Unshur, Ahmed
Oyier, Fredrick O.
Mowlid, Shafe A.
Owino, Brian
Ochieng, Steve B.
Okello, Charles I.
Montgomery, Joel M.
Wagacha, Burton
Galev, Aleksandar
Abdow, Abdikadir
Esona, Mathew D.
Tate, Jacqueline
Fitter, David
Cookson, Susan T.
Arunmozhi, Balajee
Marano, Nina
Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border
title Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border
title_full Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border
title_fullStr Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border
title_full_unstemmed Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border
title_short Evaluation of the Field Performance of ImmunoCard STAT!(®) Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border
title_sort evaluation of the field performance of immunocard stat!(®) rapid diagnostic test for rotavirus in dadaab refugee camp and at the kenya–somalia border
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5462563/
https://www.ncbi.nlm.nih.gov/pubmed/28719278
http://dx.doi.org/10.4269/ajtmh.16-0885
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