Accu-Tell^® Rotavirus Cassette (Feces)

Product Description

CATALOG

KEY POINTS

Detection for: Group A rotavirus antigen in fecal specimens；

Reading time: 5-10 minutes;

Clinical Comparison：greater than 98.57% agreement for rotavirus positive samples, and greater than 99.58% agreement for rotavirus negative samples;

Level of Detection: 1 x 10⁶ particles/ml for rotavirus

INTENDED USE

ACCU-TELL^® Rotavirus Cassette (Feces) is a rapid test for the qualitative detection of group A rotavirus antigen assay in fecal specimens. The test is intended for professional use only.

TEST PROCEDURE

Preparation

1. Test device and patient’s sample should be brought to room temperature (15-30℃/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 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.

PERFORMANCE CHARACTERISTICS

Clinical Comparison:

When compared to other commercially available rapid rotavirus kits, ACCU-TELL^® Rotavirus Cassette (Feces) gave greater than 98.57% agreement for rotavirus positive samples, and greater than 99.58% agreement for rotavirus negative samples.

Interference:

Cross-reactivity to samples positive for the following pathogens was tested and found to be negative:

escherichia coli, shigella sonnei, shigella dysenteriae, salmonella enteritidis, vibrio cholerae, salmonella typhi, staphylococcus aureus, neisseria gonorrhoeae, pseudomonas aeruginosa, b-chain cocci, enterococcus faecalis, common proteus, group c streptococcus, enterococcus faecium, klebsiella pneumoniae, proteus mirabilis, b. catarrhalis, acinetobacter, haemophilus influenzae, salmonella choleraesuis , candida albicans, gardnerella vaginalis, neisseria meningitidis, acinetobacter calcoaceticus, chlamydia trachomatis, astrovirus, diarrhea escherichia coli, coronavirus, hepatitis a, enterovirus and koza odd virus.

Reproducibility:

Reproducibility of ACCU-TELL^® Rotavirus Cassette (Feces) was determined using Ten negative fecal samples, 10 samples of rotavirus low to high positive responses, and 10 samples of adenovirus low to high positive responses. These samples were tested in replicates of 10 days in a blind study by 3 operators working independently in the same laboratory. No change in intensity of result color was detected upon repeated testing of the same sample. The agreement of the expected result was 100%.

Prozone Effect

Concentrated virus antigen was prepared from a cell culture displaying 100% cytopathic effect. Dilutions of this concentrated preparation were tested in order to determine whether antigen concentration influences the assay. The following results were recorded, according to the intensity of the colored band:

Rotavirus:

Antigen dilution  1:1     1:2    1:4   1:10    1:20

Result                ++++    +++   +++   ++     +  

The results clearly show the absence of prozone effect.

Level of detection

A positive sample with known concentration of antigen particles was diluted with buffer and assayed for presence of virus. The lowest virus concentration giving a positive result was about 1 x 10⁶ particles/ml for rotavirus. This concentration of virus is far below those found during the active phase of the disease (10⁷ - 10¹¹ particles/ml).

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 ACCU-TELL® Rotavirus Cassette (Feces) does not exclude a co-infection with other enteric pathogens.

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

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.