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 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.
Highlights
Every year, 1.7 billion cases of diarrhea and 800,000 diarrheaassociated deaths occur worldwide among children aged < 5 years.[1,2] In refugee camps in Africa, diarrhea remains a major cause of childhood morbidity and mortality, accounting for 10% of morbidity, 7% of deaths, and an estimated incidence of 35.5 cases/1,000 population/month in children < 5 years.[3]
We evaluated the field performance of ImmunoCard STAT!® Rotavirus (ICS-RV) in Dadaab Refugee Camp and at the Kenya–Somalia border
In June 2009, World Health Organization (WHO) recommended the inclusion of rotavirus vaccine in national immunization programs, especially in countries where children are at high risk of severe disease, as part of the strategy to control rotavirus-associated diarrheal diseases.[12]
Summary
1.7 billion cases of diarrhea and 800,000 diarrheaassociated deaths occur worldwide among children aged < 5 years.[1,2] In refugee camps in Africa, diarrhea remains a major cause of childhood morbidity and mortality, accounting for 10% of morbidity, 7% of deaths, and an estimated incidence of 35.5 cases/1,000 population/month in children < 5 years.[3]. In July 2014, Kenya introduced the rotavirus vaccine (RotarixTM, GlaxoSmithKline, Rixensart, Belgium) in its national immunization schedule, which included refugee populations.[13]
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