FOR THE DETECTION OF ROTAVIRUS IN FAECES Intended Use The Rotavirus Ag Rapydtest® is a lateral flow immunoassay for the qualitative detection of rotavirus antigens in faecal specimens. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with rotavirus. Performance Characteristics Serotype Detection The Rotavirus Ag Rapydtest® detects Group A rotavirus. Cross-Reactivity The cross-reactivity of the Rotavirus Ag Rapydtest® was assessed by testing faecal specimens collected from patients with other gastro-intestinal infectious diseases. No cross-reactivity was observed. Clinical Performance Clinical Performance of rotavirus specimens: 107 faecal samples collected from subjects with symptomatic diarrhoea and non-diarrhoea symptoms were tested with the Rotavirus Ag Rapydtest® and with a reference rapid test. Comparison for all subjects is shown in the table. Relative Sensitivity: 100% Relative Specificity: 97.2% Overall Agreement: 98.1% VIROLOGY SINGLE USE IN VITRO DIAGNOSTIC DEVICE

Reagents and Materials Provided 1. Individually sealed foil pouches containing: a. One cassette test device. b. One desiccant. 2. Stool collection devices, each containing 2ml of extraction buffer. 3. Plastic droppers for transferring watery stool. 4. One package insert (instruction for use). Specimen Collection and Handling Consider any materials of human origin as infectious and handle them using standard biosafety procedures. Procedure for Stool Sample Collection Test Procedure Do not read results after 20 minutes. To avoid confusion, discard the test device after interpreting the result....