Effective Date: 2012-09
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.
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
A colored band appears in the control band region (C) and another
colored band appears in the R band region.
One colored band appears in the control band region (C). No band
appears in the test band region (T).
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.
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
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
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).
Contact Rebecca Yan