The Rotavirus and Adenovirus Rapid Test (Feces) is a rapid chromatographic
immunoassay for the qualitative detection of rotavirus and adenovirus in human fecal
specimens to aid in the diagnosis of rotavirus or adenovirus infection.
【SUMMARY】
Acute diarrhea disease in young children is a major cause of morbidity worldwide and
is a leading cause of mortality in developing countries. Rotavirus is the most common
agent responsible for acute gastroenteritis, mainly in young children.1 With
hospitalized children suffering from acute enteric disease up to 50% of the analyzed
specimen were positive for rotavirus.2 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.
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.3,4,5,6 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.3,4,5,6 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 Rotavirus and Adenovirus Rapid Test is a rapid chromatographic immunoassay
for the qualitative detection of rotavirus and adenovirus in human fecal specimen,
providing results in 10 minutes. The test utilizes antibody specific for rotavirus and
adenovirus to selectively detect rotavirus and adenovirus from human fecal
specimens.
【PRINCIPLE】
The Rotavirus and Adenovirus Rapid Test is a qualitative, lateral flow immunoassay
for the detection of rotavirus and adenovirus in human fecal specimen.
In this test, the membrane is pre-coated with anti-rotavirus antibody on the T1 test
line region of the test and anti-adenovirus antibody on the T2 test line region of the
test. During testing, the specimen reacts with the particle coated with anti-rotavirus
antibody and anti-adenovirus antibody. The mixture migrates upward on the
membrane chromatographically by capillary action to react with anti-rotavirus
antibody and anti-adenovirus antibody on the membrane and generate a colored line.
The presence of these colored lines in test line regions indicate a positive result,
while their 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-rotavirus antibody and anti-adenovirus antibody coated
particles, anti-rotavirus antibody 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 Rotavirus and
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 Rotavirus and 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 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, 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.
