This Group A Rotavirus Antigen Rapid Test Kit is an in-vitro immunoassay and is used for the qualitative detection of the Group A Rotavirus in human fecal specimens in just one step. It is for the diagnosis of early infection and epidemic survey. This kit is intended only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as commercial enzyme immunoassay (ELISA) or RT-PCR.
Rotavirus (RV) belongs to Rotavirus genus in the family Reoviridae and is recognized as the major etiology agents of severe, dehydrating diarrhea and acute gastroenteritis in infants and young children worldwide. Enteral Rotavirus infections are transmitted via fecal-oral route from person to person or contaminated objects can be the source of infection. It was said that about 600 to 800 thousand people died each year from this virus. Even in the developed countries in which the mortality is much lower than the developing countries, rotavirus is responsible for 30 to 60% of all cases of acute gastroenteritis reported each year. Scientist had described seven rotavirus groups from A to G. Only groups A, B, and C infect humans. Group A, has multiple strains, causes the majority of childhood infections. The golden standard for the diagnosis of Rotavirus infections is direct detection by the electron microscopy.
PRINCIPLES OF THE ASSAY
The test kit applies a sandwich solid phase immunochromatography to qualitatively detect the group A rotavirus antigen in a human stool specimen. A nitrocellulose-based membrane is coated with goat-polyclonal antibodies and the gold-labeled selected mouse-monoclonal antibodies are used as the detector materials. Add an aliquot of diluted stool sample to the sample well of the test cassette and if the sample contains the antigens, antigen-antibody-gold complexes will form. These complexes then move on the membrane by the capillary action to the test line region on which rotavirus specific antibodies are immobilized. As the complexes reach the test line, it will bind to the antibody on the membrane and form of a pink line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the device is functioning properly. If rotavirus antigen is not present or lower than the detection level, only the control line will be visible. If the control line is not developed, the test is invalid. The test results are intended to aid in the diagnosis of rotavirus infection and to monitor the effectiveness of therapeutic treatment, it is fast and easy to operate.
25 x 1tests (strip), 20x1 tests (Cassette) Rotavirus test Cassette and each cassette contain a test strip with:
T-line coated goat-polyclonal anti-rotavirus antibody. And the colored mouse-monoclonal anti-rotavirus antibodies-gold conjugate pad
Sample tube for extraction
Instructions: 1 copy
The components of different batches and different varieties of kits are not mixed.
SAMPLE COLLECTION AND PRESERVATION
Sample collection swab
For a portion of feces (about 100mg), insert the sterile swab into the sample under visual inspection.
Open the sample collection tube and insert the swab into the tube containing assay diluents. Swirl the swab for at least 10 times until the samples has been dissolved completely into the assay diluents sand discard the swab while squeezing the swab against the wall of the tube and replace the cap. Specimen extracted in assay diluents must be stored at 2 to 8ºC for up to 1 to 2 days prior to testing.
Specimen transport and storage
Specimen should be tested as soon as possible after the collection. Do not use any kind of transport media to store the specimens.
Fecal sample must be stored or refrigerated at 2 to 8ºC for about 48hours. If longer storage is required, freezing it at -20ºC is recommended.
Bring the membrane plate and samples to the room temperature between 20 to 30°C before use for approximately 30 minutes.
Remove the test cassette or strip from the sealed foil pouch and place the plate on a flat desk.
Bring all materials and specimens to room temperature (8 to 30°C).
Group A Rotavirus test strip
Add 500Î¼l sample diluents into the test tube.
Add proper specimens (S: 5 mm in diameter, L: 50Î¼l) into the tube to make the concentration of the solution up to 5% to 10% and mix thoroughly.
Add 100Î¼l (2 to 3drops) of diluted stool sample to the sample pad of the test strip
Note: Reading the results after 15 minutes may not be accurate.
INTERPRETATION OF RESULTS
Positive: If two pink lines appears in both the C and T position
Negative: If only one pink line appear in the C position.
Invalid: The control line next to the test line does not form.
The testing is for qualitative diagnosis. Confirmation of the infection should refer to the clinical and other diagnosis.
Negative results do not exclude the possibility of rotavirus infection in the patient.
Both plate and the sample should be with room temperature 20 to 25°C
Failure to detect rotavirus may be a result of factors such as collection of specimen at an improper time in the disease when few virions were present and improper sampling or handling of the specimen.
Wrong result can be caused by the expired kit or problematic samples.
STORAGE AND STABILITY
Store at room temperature and the shelf life is of 24months. Do not use the kit beyond its expiry date.