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Astrovirus one step card test is a coloured chromatographic immunoassay for the qualitative detection of Astrovirus in stool samples.
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INTENDED USE
Astrovirus one step card test is a coloured chromatographic immunoassay for the qualitative detection of Astrovirus in stool samples.
Astrovirus card test offers a simple and a highly sensitive screening assay to make a presumptive diagnosis of Astrovirus infection.
INTRODUCTION
Rotavirus, Adenovirus and Astrovirus are most common and major causes of severe gastroenteritis in infants and young children. Pattern also
observed in adults. They are transmitted by faecal-oral contact. The main symptoms of viral gastroenteritis are watery diarrhoea and vomiting.
The affected person may also have headache, fever and abdominal cramps ("stomach ache"). In general, the symptoms begin 1 to 2 days
following infection with a virus that causes gastroenteritis and may last for 1 to 10 days, depending on which virus causes the illness (Rotavirus
3 days, Adenovirus 5-8 days and Astrovirus 3 days).
TEST PRINCIPLE
Astrovirus is based on the principle of a qualitative immunochromatographic assay for the determination of Astrovirus in stool samples.
The strip consists of a nitrocellulose membrane pre-coated with mouse monoclonal antibodies on the test line (T), in the results window, against
Astrovirus and with rabbit polyclonal antibodies, on the control line (C), against a specific protein. The label/sample absorbent pad is sprayed
with test label solution (mouse monoclonal antibodies anti-Astrovirus) conjugated to red polystyrene latex and control label solution (specific
binding protein) conjugated to green polystyrene latex, forming coloured conjugate complexes.
If the sample is positive, the antigens of the diluted sample react with the red-coloured conjugate complex (anti-Astrovirus monoclonal
antibodies-red polystyrene microspheres), which was previously pre-dried on the absorbent pad. The mixture then moves upward on the
membrane by capillary action. As the sample flows through the test membrane, the binding conjugate complexes migrate. The anti-Astrovirus
antibodies present on the membrane (test line) capture the coloured conjugate and the red line will be visible. This band is used to interpret the
result.
If the sample is negative, there is no Astrovirus antigens presence and yet, the antigens may be present in a concentration lower than the
detection limit value, for which the reaction will not take place with the red-coloured conjugate complex. The anti-Astrovirus antibodies present
on the membrane (test line) will not capture the antigen-red-coloured conjugate complex (not formed), for which the red line will not appear.
Whether the sample is positive or not, the mixture continues to move across the membrane to the immobilized specific antibodies placed in the
control line. The anti-specific protein antibodies present on the membrane will capture control green-conjugate complex and the control line will
always appear. The presence of this green line serves as: 1) verification that sufficient volume is added, 2) that proper flow is obtained and 3) an
internal control for the reagents.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at 2-30ºC. The test is stable until the expiration date marked on its sealed pouch. The test must remain
in the sealed pouch until use. Do not freeze.
PRECAUTIONS
- For professional in vitro diagnostic use.
- Do not use after expiration date.
- All the specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. A new test must be
used for each sample to avoid contamination errors.
- The tests should be discarded in a proper biohazard container after testing.
- Reagents contain preservatives. Avoid any contact with skin or mucous membrane. Consult safety data sheet, available on request.
- Components provide in the kit are approved for use in the CerTest Astrovirus test. Do not use any other commercial kit component.
- Follow Good Laboratory Practices, wear protective clothing, use disposal gloves, goggles and mask. Do not eat, drink or smoke in the working
area.
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