Adenovirus Rapid Test Cassette

【SUMMARY】
Acute diarrheal disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. 1 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 gastroenteritis. 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.
The Adenovirus Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of adenovirus in human feces specimen, providing results in 10 minutes. The test utilizes antibody specific for adenovirus to selectively detect adenovirus from human feces specimens.

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer, and/or controls to reach room temperature (15-30°C)
prior to testing.
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean, dry specimen collection container to obtain enough virus particles. Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.
2. To process fecal specimens:
For Solid Specimens:
Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops of the liquid specimen (approximately 50 µL) into the specimen collection tube containing the extraction buffer.
Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the collection tube for reaction for 2 minutes.
3. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
4. Hold the specimen collection tube upright and unscrew the tip of the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80 mL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
5. Read the results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.
Note: If the specimen does not migrate (presence of particles), centrifuge the diluted sample contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S). Start the timer and continue from step 5 onwards in the above instructions for use.