Volume 96, Issue 6
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



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.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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  1. Galan DI, Kim SS, Graham JP, , 2013. Exploring changes in open defecation prevalence in sub-Saharan Africa based on national level indices. BMC Public Health 13: 527.[Crossref] [Google Scholar]
  2. Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM, , 2013. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet 382: 209222.[Crossref] [Google Scholar]
  3. Hershey CL, Doocy S, Anderson J, Haskew C, Spiegel P, Moss WJ, , 2011. Incidence and risk factors for malaria, pneumonia and diarrhea in children under 5 in UNHCR refugee camps: a retrospective study. Confl Health 5: 24.[Crossref] [Google Scholar]
  4. Shultz A, Omollo JO, Burke H, Qassim M, Ochieng JB, Weinberg M, Feikin DR, Breiman RF, , 2009. Cholera outbreak in Kenyan refugee camp: risk factors for illness and importance of sanitation. Am J Trop Med Hyg 80: 640645. [Google Scholar]
  5. Cronin AA, Shrestha D, Spiegel P, Gore F, Hering H, , 2009. Quantifying the burden of disease associated with inadequate provision of water and sanitation in selected sub-Saharan refugee camps. J Water Health 7: 557568.[Crossref] [Google Scholar]
  6. Cronin AA, Shrestha D, Cornier N, Abdalla F, Ezard N, Aramburu C, , 2008. A review of water and sanitation provision in refugee camps in association with selected health and nutrition indicators: the need for integrated service provision. J Water Health 6: 113.[Crossref] [Google Scholar]
  7. Ope M, Ochieng SB, Tabu C, Marano N, , 2014. Rotavirus enteritis in Dadaab refugee camps: implications for immunization programs in Kenya and Resettlement Countries. Clin Infect Dis 59: vvi.[Crossref] [Google Scholar]
  8. Nimri LF, Hijazi S, , 1996. Rotavirus-associated diarrhoea in children in a refugee camp in Jordan. J Diarrhoeal Dis Res 14: 14. [Google Scholar]
  9. World Health Organization, 2013. Rotavirus vaccines WHO position paper: January 2013: recommendations. Vaccine 31: 61706171.[Crossref] [Google Scholar]
  10. Tate JE, Burton AH, Boschi-Pinto C, Parashar UD, World Health Organization-Coordinated Global Rotavirus Surveillance Network; , 2016. Global, regional, and national estimates of rotavirus mortality in children < 5 years of age, 2000–2013. Clin Infect Dis 62 (Suppl 2): S96S105.[Crossref] [Google Scholar]
  11. World Health Organization, 2013. Rotavirus vaccines. WHO position paper: January 2013. Wkly Epidemiol Rec 88: 4964. [Google Scholar]
  12. Kiulia NM, Nyaga MM, Seheri ML, Wolfaardt M, van Zyl WB, Esona MD, Irimu G, Inoti M, Gatinu BW, Njenga PK, Taylor MB, Nyachieo A, , 2014. Rotavirus G and P types circulating in the eastern region of Kenya: predominance of G9 and emergence of G12 genotypes. Pediatr Infect Dis J 33 (Suppl 1): S85S88.[Crossref] [Google Scholar]
  13. Sigei C, Odaga J, Mvundura M, Madrid Y, Clark AD, Kenya ProVac Technical Working Group Uganda ProVac Technical Working Group; ; , 2015. Cost-effectiveness of rotavirus vaccination in Kenya and Uganda. Vaccine 33 (Suppl 1): A109A118.[Crossref] [Google Scholar]
  14. Dennehy PH, Hartin M, Nelson SM, Reising SF, , 1999. Evaluation of the ImmunoCardSTAT! rotavirus assay for detection of group A rotavirus in fecal specimens. J Clin Microbiol 37: 19771979. [Google Scholar]
  15. Kettler H, White K, Hawkes S, , 2004. Mapping the Landscape of Diagnostics for Sexually Transmitted Infections. Geneva, Switzerland: World Health Organization. [Google Scholar]
  16. United Nations High Commissioner for Refugees, 2014. Camp Population Statistics by Country of Origin, Sex and Age Group. Available at: http://data.unhcr.org/horn-of-africa/documents.php?page=1&view=grid&Region%5B%5D=3&Type%5B%5D=3. Accessed January 29, 2016. [Google Scholar]
  17. World Health Organization, 2005. Handbook: IMCI Integrated Management of Childhood Illness. Geneva, Switzerland: World Health Organization. [Google Scholar]
  18. Kenya Meteorological Department, 2016. World Meteorological Organization Programmes: World Weather Informations Service, Official Forecast. Available at: http://worldweather.wmo.int/en/city.html?cityId=1795. Accessed July 20, 2016. [Google Scholar]
  19. Cortese MM, Parashar UD, Centers for Disease Control and Prevention, , 2009. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 58: 125. [Google Scholar]
  20. World Health Organization, 2005. The Treatment of Diarrhoea: A Manual for Physicians and Other Senior Health Workers, 4th revision. Geneva, Switzerland: World Health Organization. [Google Scholar]
  21. Risk R, Naismith H, Burnett A, Moore SE, Cham M, Unger S, , 2013. Rational prescribing in paediatrics in a resource-limited setting. Arch Dis Child 98: 503509.[Crossref] [Google Scholar]
  22. Lee SY, Hong JH, Lee SW, Lee M, , 2007. Comparisons of latex agglutination, immunochromatography and enzyme immunoassay methods for the detection of rotavirus antigen [in Korean]. Korean J Lab Med 27: 437441.[Crossref] [Google Scholar]
  23. Li LL, Liu N, Humphries EM, Yu JM, Li S, Lindsay BR, Stine OC, Duan ZJ, , 2016. Aetiology of diarrhoeal disease and evaluation of viral-bacterial coinfection in children under 5 years old in China: a matched case-control study. Clin Microbiol Infect 22: 381.e9381.e16.[Crossref] [Google Scholar]
  24. Mason J, Iturriza-Gomara M, O'Brien SJ, Ngwira BM, Dove W, Maiden MC, Cunliffe NA, , 2013. Campylobacter infection in children in Malawi is common and is frequently associated with enteric virus co-infections. PLoS One 8: e59663.[Crossref] [Google Scholar]
  25. Tate JE, Mijatovic-Rustempasic S, Tam KI, Lyde FC, Payne DC, Szilagyi P, Edwards K, Staat MA, Weinberg GA, Hall CB, Chappell J, McNeal M, Gentsch JR, Bowen MD, Parashar UD, , 2013. Comparison of 2 assays for diagnosing rotavirus and evaluating vaccine effectiveness in children with gastroenteritis. Emerg Infect Dis 19: 12451252.[Crossref] [Google Scholar]
  26. Phillips G, Lopman B, Tam CC, Iturriza-Gomara M, Brown D, Gray J, , 2009. Diagnosing rotavirus A associated IID: using ELISA to identify a cut-off for real time RT-PCR. J Clin Virol 44: 242245.[Crossref] [Google Scholar]

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  • Received : 09 Nov 2016
  • Accepted : 21 Jan 2017
  • Published online : 27 Mar 2017

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