American Journal of Tropical Medicine and Hygiene
Volume 96, Issue 6, 2017, Pages 1302-1306

Evaluation of the field performance of ImmunoCard STAT!® rapid diagnostic test for rotavirus in Dadaab refugee camp and at the Kenya-Somalia Border (Article) (Open Access)

Ope M.* , Nyoka R. , Unshur A. , Oyier F.O. , Mowlid S.A. , Owino B. , Ochieng S.B. , Okello C.I. , Montgomery J.M. , Wagacha B. , Galev A. , Abdow A. , Esona M.D. , Tate J. , Fitter D. , Cookson S.T. , Arunmozhi B. , Marano N.
  • a U.S. Centers for Disease Control and Prevention, P.O. Box 606-00621 Village Market, Nairobi, Kenya
  • b U.S. Centers for Disease Control and Prevention, P.O. Box 606-00621 Village Market, Nairobi, Kenya
  • c Kenya Medical Research Institute, Dadaab, Kenya
  • d Kenya Medical Research Institute, Dadaab, Kenya
  • e Kenya Medical Research Institute, Dadaab, Kenya
  • f Kenya Medical Research Institute, Dadaab, Kenya
  • g Kenya Medical Research Institute, Dadaab, Kenya
  • h U.S. Centers for Disease Control and Prevention, P.O. Box 606-00621 Village Market, Nairobi, Kenya
  • i U.S. Centers for Disease Control and Prevention, P.O. Box 606-00621 Village Market, Nairobi, Kenya
  • j United Nations High Commissioner for Refugees, Nairobi, Kenya
  • k International Organization for Migration, Nairobi, Kenya
  • l International Organization for Migration, Nairobi, Kenya
  • m U.S Centers for Disease Control and Prevention, Atlanta, GA, United States
  • n U.S Centers for Disease Control and Prevention, Atlanta, GA, United States
  • o U.S Centers for Disease Control and Prevention, Atlanta, GA, United States
  • p U.S Centers for Disease Control and Prevention, Atlanta, GA, United States
  • q U.S Centers for Disease Control and Prevention, Atlanta, GA, United States
  • r U.S. Centers for Disease Control and Prevention, P.O. Box 606-00621 Village Market, Nairobi, Kenya

Abstract

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 usingWorld 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%weremale. 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 theWHO 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. Copyright © 2017 by The American Society of Tropical Medicine and Hygiene.

Author Keywords

[No Keywords available]

Index Keywords

prospective study hospitalization refugee controlled clinical trial Point-of-Care Testing predictive value Rotavirus Infections Prospective Studies human Refugees feces analysis controlled study acute diarrhea acute disease Rotavirus Kenya loose feces Humans virology male preschool child female Infant Child, Preschool evaluation study diagnostic test refugee camp rapid test diarrhea hospitalized child isolation and purification sensitivity and specificity Article Disease Outbreaks epidemic Diagnostic Tests, Routine major clinical study Somalia Rotavirus infection world health organization point of care testing enzyme immunoassay gold standard immunoassay immunoassay analyzer Child
Link
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85020404310&doi=10.4269%2fajtmh.16-0885&partnerID=40&md5=d4a1f2f06f8fac636b5dc2fd0ea5566d
DOI: 10.4269/ajtmh.16-0885
ISSN: 00029637
Cited by: 2
Original Language: English