The Norovirus/Rotavirus/Adenovirus Combo Rapid Test (Feces) is a rapid
chromatographic immunoassay for the qualitative detection of Norovirus/Rotavirus/
Adenovirus in human feces specimens to aid in the diagnosis of norovirus, rotavirus or
adenovirus infection.
【SUMMARY】
The Norovirus/Rotavirus/Adenovirus Combo Rapid Test is a rapid chromatographic
immunoassay for the qualitative detection of norovirus/rotavirus/adenovirus in human
fecal specimen. The test utilizes antibody specific for norovirus/rotavirus/adenovirus to
selectively detect norovirus/rotavirus/adenovirus in human fecal specimens.
The Combo Test comprises of 3 parts, viz., norovirus/rotavirus/adenovirus. The details
for each part are given below.
For Norovirus Rapid Test (Feces): Noroviruses (NoV) are a genetically diverse group
of single stranded RNA, nonenvelopped viruses belonging to the Caliciviridae family.
Noroviruses are a major cause of acute gastroenteritis worldwide, often causing
explosive outbreaks in institutions. Transmission is predominantly faecal-oral but may
be airborne due to aerosolisation of vomitus, which typically contains abundant
infectious virus particles. The illness is acute, usually mild, although it has caused
fatalities among the frail elderly, and self-limiting and follows an incubation period of
24-48 hours although cases can occur within 12 hours of exposure.The symptoms of
Norovirus illness usually include nausea, vomiting, diarrhea, and some stomach
cramping. Sometimes people additionally have a low-grade fever, chills, headache,
muscle aches, and a general sense of tiredness. The illness often begins suddenly, and
the infected person may feel very sick. In most people the illness is self-limiting with
symptoms lasting for about 1 or 2 days.1
For Rotavirus Rapid Test (Feces): Acute diarrheal 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.2 Rotavirus is transmitted by oral-fecal route with an incubation
period of 1-3 days. Although specimen collections taken within the second and fifth day
of the illness are ideal for antigen detection, the rotavirus may still be found while
diarrhea continues. Rotaviral gastroenteritis may result in mortality for populations at
risk such as infants, the elderly and immunocompromised patients.3 In temperate
climates, rotavirus infections occur mainly in the winter months. With hospitalized
children suffering from acute enteric disease up to 50% of the analyzed specimen were
positive for rotavirus.4
For Adenovirus Rapid Test (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.5 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 4-17% of all hospitalized
cases of viral gastroenteritis.6 Rapid and accurate diagnosis of gastroenteritis due to
adenovirus is helpful in establishing the etiology of gastroenteritis and related patient
management.
【PRINCIPLE】
The Norovirus Rapid Test (Feces) is a qualitative, lateral flow immunoassay for the
detection of Norovirus in human feces. The assay uses Genogroup 1 and Genogroup 2
specific monoclonal antibodies coated on the test membrane. During testing, the stool
specimen reacts with the conjugate antibodies. The mixture migrates upward on the
membrane chromatographically by capillary action to react with Genogroup 1 and 2
antibodies on the membrane and generates a colored line at the level of the T line. The
presence of a colored line in T region indicates a positive result for Genogroup 1 and/or
Genogroup 2, while its absence indicates a negative result. To serve as a procedural
control, a colored line will always appear in the control reaction zone (C) indicating that
proper volume of specimen has been added and membrane wicking has occurred.
The Rotavirus Rapid Test (Feces) is a qualitative, lateral flow immunoassay for the
detection of rotavirus in human feces. In this test, the membrane is pre-coated with
rotavirus specific monoclonal antibody on the T line region of the test. During testing,
the specimen reacts with the particle coated with rotavirus antibody. The mixture
migrates upward on the membrane chromatographically by capillary action to react with
rotavirus antibody on the membrane and generate a colored line. The presence of the
colored line in test line region indicates 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.
The Adenovirus Rapid Test (Feces) is a qualitative, lateral flow immunoassay for the
detection of adenovirus in human feces. In this test, the membrane is pre-coated with
adenovirus specific monoclonal antibody on the T line region of the test. During testing,
the specimen reacts with the particle coated with adenovirus antibody. The mixture
migrates upward on the membrane chromatographically by capillary action to react with
adenovirus antibody on the membrane and generate a colored line. The presence of the
colored line in test line region indicates 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 Combo Test comprises of four parts and details of each part are given herewith.
The Norovirus rapid test contains Norovirus Genogroup 1 and Genogroup 2 monoclonal
antibody coated particles and Norovirus Genogroup 1 and Genogroup 2 monoclonal
antibodies coated on the membrane.
The Rotavirus rapid test contains anti-rotavirus antibody coated particles and
anti-rotavirus antibody coated on the membrane.
The Adenovirus rapid 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 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.
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.
Keep out of the reach of children.
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 Norovirus/Rotavirus/
Adenovirus Combo 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】
1. The fecal specimen must be collected in a clean, dry, waterproof container
containing no detergents, preservatives or transport media.
2. No dietary restrictions are necessary before using the Norovirus/Rotavirus/Adenovirus
Combo Rapid Test.
3. Bring the necessary reagents and fecal specimen to room temperature before use.
4. 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 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. 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 15 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.
