Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783242535654653952 |
---|---|
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. |
format | Online Article Text |
id | pubmed-5462563 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | The American Society of Tropical Medicine and Hygiene |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT opemaurice evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT nyokaraymond evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT unshurahmed evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT oyierfredricko evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT mowlidshafea evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT owinobrian evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT ochiengsteveb evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT okellocharlesi evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT montgomeryjoelm evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT wagachaburton evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT galevaleksandar evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT abdowabdikadir evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT esonamathewd evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT tatejacqueline evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT fitterdavid evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT cooksonsusant evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT arunmozhibalajee evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder AT maranonina evaluationofthefieldperformanceofimmunocardstatrapiddiagnostictestforrotavirusindadaabrefugeecampandatthekenyasomaliaborder |