The Adenovirus Rapid Test (Feces) is a rapid chromatographic immunoassay for the
qualitative detection of Adenovirus in human fecal specimens to aid in the diagnosis of
Adenovirus infection.
【SUMMARY】
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.1,2,3,4 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. 1,2,3,4 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 (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.
【PRINCIPLE】
The Adenovirus Rapid Test is a qualitative, lateral flow immunoassay for the detection of
adenovirus in human feces specimens.
In this test, the membrane is pre-coated with anti-adenovirus antibody on the test line region
of the test. During testing, the specimen reacts with the particle coated with anti-adenovirus
antibody. The mixture migrates upward on the membrane chromatographically by capillary
action to react with anti-adenovirus antibody on the membrane and generate a colored line
in the test line region. The presence of this colored line in the test region indicates a positive
result, while its absence indicates a negative result. To serve as a procedural control, a
colored line will always appear in the control line region indicating that proper volume of
specimen has been added and membrane wicking has occurred.
【REAGENTS】
The test contains anti-adenovirus antibody coated particles and anti-adenovirus antibody
coated on the membrane.
【PRECAUTIONS】
Please read all the information in this package insert before performing the test.
• For professional use only. For in vitro diagnostic use only.
• Do not use after the expiration date. Do not reuse the test.
• Store in a dry place at 2-30°C (36-86°F), avoiding areas of excess moisture. If the foil
packaging is damaged or has been opened, please do not use.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout all procedures and follow the
standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection
when specimens are assayed.
• The used test should be discarded according to local regulations.
• Humidity and temperature may adversely affect results.
• Wash hands thoroughly before and after handling.
• Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority.
• Use the test only once. Keep the test upright while testing. Do not move or turn the
test upside down.
• The kit must not be frozen or used after the expiration date printed on the package.
• Components provided in the kit are approved for use in the Adenovirus Rapid Test. Do
not use any other commercial kit component.
【STORAGE AND STABILITY】
The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable
through the expiration date printed on the sealed pouch. The test must remain in the sealed
pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
NOTE: It is suggested to use the test within one hour after removing it from the foil pouch.
【SPECIMEN COLLECTION AND PREPARATION】
• The fecal specimen must be collected in clean, dry, waterproof container containing no
detergents, preservatives or transport media.
• No dietary restrictions are necessary before using the Adenovirus Rapid Test.
• Bring the necessary reagents and feces specimen to room temperature before use.
• If specimens are to be shipped, they should be packed in compliance with local
regulations covering the transportation of etiologic agents.
【MATERIALS】
Materials Provided
Test Cups (with dilution buffer)
Package Insert
Droppers
Materials Required but Not Provided
Timer
Centrifuge
Specimen Container
Pipette
【DIRECTIONS FOR USE】
Before performing the test, allow the test and specimen to reach room temperature
(15-30°C), stool samples must be collected following the instruction below.
1. Wash your hands with soap and rinse with clear water.
2. Collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection
container. 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.
3. Bring the pouch to room temperature before opening it. Remove the test cup 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. Process fecal specimens:
•
For Solid Specimens:
Unscrew the cap of the test cup and take out the specimen collection applicator.
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 test cup containing the dilution buffer.
5. Insert the specimen collection applicator back into the test cup and tighten the cap.
6. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction for
2 minutes.
7. Remove the plastic limit strip of the test cup.
8. Put the test cup on a clean and level surface, press the cup body from the top to the
bottom and start the timer.
NOTE: Keep the test cup upright during the test developing. Do not move or turn the test
cup upside down.
9. Read results at 10 minutes. Do not read results after 20 minutes.
NOTE: If the specimen does not migrate (presence of particles), open a new test cup,
repeat step 4 and centrifuge the diluted specimen contained in the test cup with a clean
tube. Pipette 1-1.5 mL of supernatant, dispense into the test cup and insert the specimen
collection applicator back into the test cup and tighten the cap. Continue from step 7-8
onwards in the above instructions for use and start the timer.