Rota Virus Antigen Sensitivity Colloidal Gold Rapid Test For Human Diagnosis

Group A Rotavirus Antigen Rapid Test Kit

Product Description:

Bioneovan Group A Rotavirus Antigen Rapid Test Kit is an in vitro immunoassay for the qualitative determination of the detection of Group A Rotavirus in human faecal specimens in one step. It is for diagnosis of early infection and epidemic survey. The kit is intended only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as commercial anzyme immunoassay (ELISA) or RT-PCR.

Rotavirus (RV) belongs to the genus Rotavirus of the family Reoviridae and is considered the main pathogenic agent of severe dehydrating diarrhea and acute gastroenteritis in infants and young children around the world. Enteric rotavirus infection is spread from person to person via the fecal-oral route, and contaminated objects may also be a source of infection. It is said that approximately 600 to 800,000 people die from rotavirus every year. Even in developed countries, where mortality rates are much lower than those in developing countries, rotavirus accounts for 30 to 60% of all cases of acute gastroenteritis reported each year. Scientists have described seven rotavirus groups (A through G). Only groups A, B and C infect humans. Group A has a variety of strains that cause most infections in children. The gold standard for diagnosing rotavirus infection is direct detection of the virus by electron microscopy.

Principles of the Assay:

This kit uses a sandwich solid-phase immunochromatography method to detect group A rotavirus antigens in human feces. It contains a nitrocellulose membrane pre-coated with goat polyclonal antibodies and gold-labeled specially selected mouse monoclonal antibodies as detection material. The user adds an aliquot of the diluted stool sample to the sample well of the test cartridge. If rotavirus antigen is present in the sample, an antigen-antibody-gold complex will form. These complexes move by capillary action on the nitrocellulose membrane toward the area of the test line where rotavirus-specific antibodies are immobilized. When the complexes reach the test line, they bind to the antibodies on the membrane, forming a pink line. A second red control line always appears in the results window, indicating that the test performed normally and the device is functioning well. If the rotavirus antigen is absent or below the detection limit, only the control line is visible. If the control line does not develop color, the test is invalid. The test results can be used to diagnose rotavirus infection and monitor the effectiveness of treatment, easily and quickly.

Sample Collection and Preservation

1. Sample collection swab
• Take a portion of the feces (approximately 100mg) and insert a sterile swab into the fecal sample with the most secretions observed with the naked eye. • Open the sample collection tube and insert the swab into the sample collection tube containing the assay diluent. Swirl the swab at least 10 times until the sample is dissolved in the assay diluent, then discard the swab while squeezing the swab against the wall of the tube and replace the cap. Samples extracted in assay diluent can be stored at 2-8°C for up to 1 -2 days before testing.
2. Specimen transportation and storage
• Samples should be tested as soon as possible after collection. Do not use any type of shipping medium to store or ship specimens.
• Fecal samples can be kept refrigerated (2-8°C) for 48 hours. For longer storage, freezing at -20°C is recommended.

Test Procedure

1. Bring Membrane Plate and samples to room temperature (20-30°C) before use (approximately 30 minutes).

2. Remove the test cassette/strip from the sealed foil pouch and place the plate on flat desk.

3. Bring all materials and specimens to room temperature (8～30℃).

4.1 Group A Rotavirus test strip

1) Add 500μl sample diluents into the test tube.

2) Add proper specimens (S:5 mm in diameter, L: 50μl) into the tube to make the concentration of the solution up to 5%～10% and mix thoroughly.

3) Deliver 100μl (2～3drops ) of diluted stool sample to the sample pad of the test strip.

4.2 Group A Rotavirus test cassette

1) To take a portion of feces (about 100mg), insert the sterile swab into a stool sample that presents the most secretion under visual inspection.

2) Open the sample collection tube and then insert the swab into the sample collection tube containing assay diluents.

3) Swirl the swab at least 10 times until the samples has been dissolved into the assay diluents and discard the swab while squeezing the swab against the wall of tube, replace the cap.

4) Deliver 100μl (2～3drops ) of diluted stool sample to the sample well of the test card.

5. Read the result in 5～10 minutes. A strong positive sample may show result earlier.

Note: Results after 15 minutes may not be accurate.

Support and Services:

The Colloidal Gold Rapid Test product provides technical support and services to ensure accurate and reliable results. Our team of experienced professionals is available to assist with any questions or concerns regarding the product's usage, interpretation of results, or troubleshooting issues. We offer comprehensive training and education resources to help users optimize their testing process and minimize errors. Additionally, we provide regular product updates and maintenance services to ensure the highest level of performance and customer satisfaction. Contact us for more information on our technical support and services.

Packing and Shipping:

25x1 tests (strip), 20x1 tests (Cassette)

Group A Rotavirus test Cassette /strip

Each cassette/strip contains a test strip with Goat polyclonal anti-rotavirus antibodies on the test region of the membrane and colored mouse monoclonal anti-rotavirus antibodies-gold conjugate pad.

Precautions

1. Both plate and sample should be with room temperature 20-25°C

2. Failure to detect rotavirus may be a result of factors such as collection of specimen at an improper time in the disease when too few virions are present and improper sampling or handling of the specimen.

3. Wrong result might be caused by expired kit or problematic samples.

Storage and Stability

Room Temperature.