A rapid, one step test for the qualitative detection of norovirus, rotavirus, adenovirus and astrovirus
in human feces.
For self-testing in vitro diagnostic use only.
【INTENDED USE】
The Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test (Feces) is a rapid
chromatographic immunoassay for the qualitative detection of norovirus, rotavirus, adenovirus and
astrovirus in human fecal specimens to aid in the diagnosis of norovirus, rotavirus, adenovirus or
astrovirus infection.
【SUMMARY】
The Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test is a rapid chromatographic
immunoassay for the qualitative detection of norovirus, rotavirus, adenovirus and astrovirus in
human fecal specimen. The test utilizes antibody specific for norovirus, rotavirus, adenovirus and
astrovirus to selectively detect norovirus, rotavirus, adenovirus and astrovirus in human fecal
specimens.
The Combo Test comprises of 4 parts, viz., Norovirus, Rotavirus, Adenovirus and Astrovirus. 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.
For Astrovirus Rapid Test (Feces): Astrovirus is a type of virus that was first discovered in 1975
using electron microscopes following an outbreak of diarrhea in humans. Astroviruses are 28–35
nm diameter, icosahedral viruses that have a characteristic five- or sixpointed star-like surface
structure when viewed by electron microscopy.7 Astrovirus has a non-segmented, single stranded,
positive sense RNA genome within a non-enveloped icosahedral capsid.8 Human astroviruses have
been shown in numerous studies to be an important cause of gastroenteritis in young children
worldwide.
【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.
The Astrovirus Rapid Test (Feces) is a qualitative, lateral flow immunoassay for the detection of
astrovirus in human fecess. In this test, the membrane is pre-coated with astrovirus specific
monoclonal antibody on the test line region of the test. During testing, the specimen reacts with the
particle coated with astrovirus antibody. The mixture migrates upward on the membrane
chromatographically by capillary action to react with astrovirus 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 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.
The Astrovirus rapid test contains anti-astrovirus antibody coated particles and anti-astrovirus
antibody coated on the membrane.
【PRECAUTIONS】
Please read all the information in this package insert before performing the test.
• For self-testing 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.
• 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.
【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】
• Specimens should not be collected during or within three days of a menstrual period, or if the
patient suffers from bleeding hemorrhoids or blood in the urine.
• Alcohol, aspirin and other medications taken in excess may cause gastrointestinal irritation
resulting in occult bleeding. Such substances should be discontinued at least 48 hours prior to
testing.
• No dietary restrictions are necessary before using the Norovirus, Rotavirus,
Adenovirus and Astrovirus Combo Rapid Test.
【MATERIALS PROVIDED】
Test Cup (with dilution buffer)
Stool Catcher
Package Insert
Dropper
【MATERIALS REQUIRED BUT NOT PROVIDED】
Timer
Specimen Container
【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:
• For Solid feces
Solid fecal specimen should be collected in the Stool Catcher or clean collection containers.
Please use the Stool Catcher, avoiding contamination of the specimen by taking precautions
that the specimen or side of paper containing specimen does not come in contact with any
contaminating objects including toilet cleaners.
• For Liquid feces
Collect liquid feces in a clean and dry container.
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.
