Ratification of rapid rotavirus diagnostic test strips

Abstract

The World Health Organization and Centers for Disease Control and Prevention estimate that rotavirus-associated gastroenteritis is the third most common cause of death in young children, with approximately 453 000 deaths annually, and that more than 90% of these deaths occur in developing countries. An accurate diagnosis of rotavirus in stool samples is important to determine the rotavirus burden of disease, possible rotavirus vaccine failure, and to limit the inappropriate use of antibiotics. While enzyme immunoassay (EIA) is one of the most sensitive and specific testing methods to achieve this, it is relatively time consuming and expensive for laboratories that require short turnaround times. This study evaluated the sensitivity and specificity of the simpler and cheaper Combi® immunochromatographic test (ICT) strip (Coris BioConcepts, Gembloux, Belgium) routinely used by pathology practices to screen stool samples for rotaviruses. Of 6 050 stool samples collected in 2010 and 2011 from a private pathology practice in Pretoria and screened using the Combi® ICT strip, 752 (12%) were tested using a commercial, large-scale EIA detection method, e.g. ProSpecT® Rotavirus EIA kit (Oxoid Diagnostics, Basingstoke, UK). Results showed the sensitivity of the Combi® ICT strip to be 93.7% and the specificity of this assay to be 99.8%, when compared to the gold standard EIA. The study results support the use of the Combi® ICT strip as an appropriate detection assay, showing that it has a highly sensitive and specific reaction to rotavirus antigens.