Testsealabs Rotavirus Rapid Test Kit(Feces)

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Intended Use

The One Step Rotavirus Rapid Test(Feces) is a qualitative membrane strip based immunoassay for the detection of adenovirus in feces. In this test procedure, Rotavirus antibody is immobilized in the test line region of the device. After an adequate volume of test specimen is placed in the specimen well, it reacts with Rotavirus antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized Rotavirus antibody. If the specimen contains Rotavirus, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain Rotavirus, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

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Summary

Rotavirus is the second most common cause of viral gastro-enteritis in Children (10-15%). This virus may also cause respiratory diseases and, depending on the serotype, also diarrhea, conjunctivitis, cystitis, etc. At lease 47 serotypes of Rotavirus have been described, all sharing a common hexon antigen. Serotypes 40 and 41 are the ones associated with gastro-enteritis. The main syndrome is diarrhea that may last between 9 and 12 days associated with fever and vomits.

Test Procedure of Rotavirus Cassette (Feces)

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Preparation
1. Rotavirus Test device and patient's sample should be brought to room temperature (15-30C/about 20 minutes) prior to testing
2. Do not open the pouch until you are ready to perform the test. Specimen pre-treatment
1.Unscrew the sample bottle, use the attached applicator stick attached on the cap to transfer a small piece of stool. The dilution ratio must be at most 10%w/v.
--For liquid or semi-solid stools, take 2 loops of 100 μl,
--For solid samples, take 1 loop or transfer small piece of stool (4-6 mm in diameter approx.50-200 mg).
2.Replace the stick in the bottle and tighten securely. Shake tube vigorously until sample dissolves into test fluid and let stand for 1-2 minutes.
3. Extracted specimen can be stored for up to 7 days at 2-8°C prior to use.

Testing
1. Remove the Rotavirus test Cassette from the sealed foil pouch.
2. Shake the collection tube thoroughly to ensure proper mixing of the fecal sample with the extraction solution.
3. Hold the sample bottle upright with the tip pointing away from the test performer. snap off the tip.
4.Hold the bottle in a vertical position over the sample well of the test card, deliver 2 drops (60 -100μL) of diluted stool sample to the sample well.
5.Read the result between 5-10 minutes. A strong positive sample may show results earlier Note: Results after 15 minutes may not be accurate.

Limitations

1. The test is for qualitative detection of rotavirus antigen in stool sample and does not indicate the quantity of the antigens.

2. A negative result does not exclude the possibility of rotavirus infection. The quantity of virus or antigen may be too small, or the sampling may be inadequate or improper.

3.A positive result with Rotavirus Cassette (Feces) does not exclude a co-infection with other enteric pathogens.

4.As with all diagnostic tests, the results obtained with Rotavirus Cassette (Feces should be interpreted with due consideration to the clinical status of the patient.

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