Keul-o-test

One Step Rotavirus Test Cassette for Feces

KGST194

DIMDI-Reg.-Nr.: DE/CA22/1116-192-IVD

Intended Use
The One Step Rotavirus combo test is a simple one step immuno-chromatographic assay for the rapid, detection of Rotavirus in feces.

Principle
The One Step Rotavirus test employs a unique combination of monoclonal and polyclonal antibodies to selectively identify Rotavirus in test samples with a high degree of sensitivity.  The test relative sensitivity and relative specificity (to Meridian Elisa) for Rotavirus is 100%.

Storage and Stability
The one step Rotavirus test kit should be stored at room temperature or 4-30^oC (40-86^oF). The test device is sensitive to humidity and as well as to heat.  Perform the test immediately after removing the test device from the foil pouch.  Do not use it beyond the expiration date.

Warnings

1. For in vitro diagnostic use only.
2. Do not eat or smoke while handling specimens.
3. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.
4. Avoid splashing or aerosol formation.
5. Clean up spills thoroughly using an appropriate disinfectant.
6. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.
7. Do not use the test kit if the pouch is damaged or the seal is broken.

• Rotavirus Test Cassette
• Extraction Tube
• Instructions

Specimen Collection

1. Only fecal specimens should be used in this assay. It can be collected from toilet paper or caught in a clean container. Specimen should avoid contamination of toilet water.
2. Unscrew the top of the sample collection device and use the sample collection stick to collect stool sample by dipping the stick randomly into 3 different places of the same stool sample. (Figure 1)
3. Put the sample collection stick containing the sample back into the sample collection device and screw it tightly. Shake it very well.
4. Sample collected can stored at 2 to 8 ^oC for 3 days.

Procedure of the Test

1. Remove the test disk from the foil pouch, and place it on a flat, dry surface.
2. If the stool sample is refrigerated, then bring the sample collection device to room temperature. Then shake the device several times.
3. Hold the sample collection device so that the device tip facing up, then break off the tip of the collection device and squeeze 3 drops of the extracted sample into each of the sample wells. (Figure 2)
4. As the test kit begins to work, you will see purple color move across the Result Window in the center of the Test Disk.
5. Interpret test results at 9 to 10 minutes. Do not interpret test results after 10 minutes.

Caution: The above interpreting time is based on reading the test results at room temperature of 15 to 30 ^oC.  If your room temperature is significantly lower than 15 ^oC, then the interpreting time should be properly increased.

Interpretation of the Test

1. A color band will appear at the left section of the result window to show that the test is working properly. This band is the Control Band.
2. A color band will appear at the test line "T" the result window when Rota virus is detected in a sample.

Positive Result: If presence of the "C" color band along with visible test lines "T" of the Result Window (no matter which band appears first), then it indicates a positive result respectively (Figures 2).

Negative Result: If presence of only the "C" color band within the result windows then it indicates a negative result. (Figure 3)

Invalid Result: If after performing the test no color band or no "C" color band is visible within the result window, then the test is considered invalid. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested. (Figures 4)

Note: Once a positive result has been established (at 10 minutes), the result will not change.  However, in order to prevent any incorrect results, the test result should not be interpreted after 10 minutes.

Limitations of the Test
As it is the case with any diagnostic procedure, the physician should confirm the data obtained using this test by other clinical methods
A negative result does not exclude an infection. If a reasonable suspicion of an infection exists, another stool specimen should be investigated
A positive result does not exclude the presence of other pathogens

References

1. Grauballe PC, Vestergaard BF, Meyling A, Genner J. Optimized enzyme-linked immunosorbent assay for detection of human and bovine rotavirus in stools: comparison with electron-microscopy, immunoelectro-osmophoresis, and fluorescent antibody techniques. J Med Virol 1981; 7 : 29-40.
2. Flewett TH, Arias CF, Avendano LF, Ghafoor A, Mathan MM, Mendis L, et al. Comparative evaluation of the WHO and DAKOPATTS enzyme-linked immunoassay kits for rotavirus detection. Bull World Health Organ 1989; 67: 369-74.
3. Kelkar SD. Development of indigenous ELISA for rotavirus diagnosis and its  comparison with commercial kit. Indian J Med Res 1993; 97 : 93-101.
4. Kok TW, Burrell CJ. Comparison of five enzyme immunoassays, electron microscopy, and latex agglutination for detection of rotavirus in fecal specimens. J Clin Microbiol 1989; 27: 364-6.
5. Lowry OH, Rosebrough NJ, Farr AL, Randall RJ. Protein measurement with the folin-phenol reagent. JBiolChem 1951; 193 : 265-75.
6. Wilson MB, Nakano PK. Recent developments in the periodate method of conjugating horse radish peroxidase (HRP) to antibodies. In: Knapp W, Holubar K, Wides G, editors. Immune/fluorescent and related staining techniques. Amsterdam: Elsevier/North-Holland Biomedical Press; 1978 p. 215.

Hersteller:

Von-Langen-Weg 10 D-48565 Steinfurt Tel.: 02551/4090  Fax.: 02551/1298 Web: www.biogentechnologies.de