Rota virus Rapid Test Device

Specimens: Feces

INTENDED USE

The Rotavirus Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of rotavirus in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of rotavirus infection.

INTRODUCTION

Rotavirus is the most common agent responsible for acute gastroenteritis, mainly in young children. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advancement in the study of gastro-enteritis not caused by acute bacterial infection. The rotavirus may still be found while diarrhoea continues. Rotaviral gastroenteritis may result in mortality for populations at risk such as infants, the elderly, and immunocompromised patients. In temperate climates, rotavirus infections occur mainly in the winter months. Endemics as well as epidemics affecting some thousand people have been reported. With hospitalised children suffering from acute entric disease up to 50% of the analysed specimen were positive for rotavirus. The viruses replicate in the cell nucleus and tend to be host species specific producing a characteristic cytopathic effect (CPE). Because rotavirus is extremely difficult to culture, it is unusual to use isolation of the virus in diagnosing an infection. Instead, a variety of techniques have been developed to detect rotavirus in feces.

INTERPRETATION OF RESULTS

POSITIVE RESULT:

A colored band appears in the control band region (C) and another colored band appears in the R band region.

NEGATIVE RESULT:

One colored band appears in the control band region (C). No band appears in the test band region (T).

INVALID RESULT:

Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.

2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

PERFORMANCE CHARACTERISTICS

Table: Rotavirus Rapid Test vs. Latex Agglutination

Relative Sensitivity: 99.1% (96.8%-99.9%)*

Relative Specificity: >99.9% (97.7%-100.0%)

Overall Agreement: 99.5% (98.1%-99.9%)*

*95% Confidence Interval

Specificity:

Cross reactivity with following organisms has been studied at 1.0 x 10⁹ organisms/ml. The following organisms were found negative when tested with the Rotavirus Rapid Test Device (Feces).