For professional in vitro diagnostic use only
The Adenovirus Rapid Test Device (Feces) is a rapid visual
immunoassay for the qualitative presumptive detection of adenovirus
in human fecal specimens. This kit is intended to be used as an aid
in the diagnosis of adenovirus infection.
Acute diarrheal disease in young children is a major cause of
morbidity worldwide and is a leading cause of mortality in
developing countries. Research has shown that enteric adenoviruses,
primarily Ad40 and Ad41, are a leading cause of diarrhea in many of
these children, second only to the rotaviruses. These viral
pathogens have been isolated throughout the world, and can cause
diarrhea in children year round. Infections are most frequently
seen in children less than two years of age, but have been found in
patients of all ages. Further studies indicate that adenoviruses
are associated with 4-15% of all hospitalized cases of viral
Rapid and accurate diagnosis of gastroenteritis due to adenovirus
is helpful in establishing the etiology of gastroenteritis and
related patient management. Other diagnostic techniques such as
electron microscopy (EM) and nucleic acid hybridization are
expensive and labor-intensive. With the self-limiting nature of
adenovirus infection, such expensive and labor-intensive tests may
not be necessary.
INTERPRETATION OF RESULTS
A colored band appears in the control band region (C) and another
colored band appears in the A line 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: Adenovirus Rapid Test vs. Latex Agglutination
Relative Sensitivity: >99.9% (95.6%-99.9%)*
Relative Specificity: 99.4% (96.5%-99.9%)*
Overall Agreement: 99.6% (97.7%-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 Adenovirus Rapid Test Device (Feces).
Contact Rebecca Yan