Keul-o-test

One Step Rota-Adenovirus Combo Panel for feces

KGST195
DIMDI Reg.-Nr.: DE/CA22/1116-190-IVD

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

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

Storage and Stability
The one step Rota-Adenovirus combo 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.

Accessories: Rota-Adenovirus Combo 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" of the Rota section (indicated by letters of "Rota") section of the result window when Rota virus is detected in a sample.
3. A color band will appear at the test line "T" of the Adenovirus section (indicated by letter "Adeno") section of the result window when Adenovirus is detected in a sample.

Positive Result: If presence of the "C" color band along with either or both visible test lines "T" of the Rotavirus and Adenovirus sections (no matter which band appears first), then it indicates a positive result respectively (Figures, 3, 4, 5).

Negative Result: If presence of only the "C" color band within the result windows in both the Rotavirus and Adenovirus sections, then it indicates a negative result. (Figure 6)

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 7 and 8)

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.

Performance characteristics

Sensitivity and Specificity
In a in-house study with 45 subjects, the relative sensitivity of the Keul-o-test Rota-Adenovirus-Combo test is found to be 96,3%/95,2% and the relative specificity is 100% when compared to the Median Elisa.

Cross-Reactivity
The following organisms were tested at 1.0 x 10⁷ organisms per test and were all found to be nagative when tested with the Keul-o-test Rota-Adenovirus-Combo test device. No mucoid-producing strains were tested.

• Branhamella catarrhalis (ATCCâ 43628)
• Candida ablicans (ATCCâ 14053)
• Corynebacterium diptheriae (ATCCâ 9015)
• Eschericha coli (ATCCâ 25922)
• Haemophilus influenzae (ATCCâ 35056)
• Klebsiella pneumonia (ATCCâ 9826)
• Neisseria gonorrhorae (ATCCâ 9826)
• Neisseria menigitidis, Serumgruppe B (ATCCâ 13090)
• Neisseria sp. (ATCCâ 43831)
• Pseudomonas aeruginosa (ATCCâ 27853)
• Serratia marcescens (ATCCâ 8100)
• Staphylococcus aureus (ATCCâ 29213 & 25923)
• Staphylococcus epidermidis (ATCCâ 12228)

• Staphylococcus pneumoniae (ATCCâ 9163, 6306 & 10015)

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. Kapi, A-Z., H. W. Kim, R.G. Wyatt, W.L. Cline, J.0. Arrobio, C.D. Br:andt, W. J. Rodriguez, D.A. Sack, R.M. Chanock, and R.11. Parrott. 1976. Human reovirus-like agent as the major pathogen associated with "winter" gastroenteritis in hospitalized infants and young children, N. Engl.j.Med. 294:965-972
2. Schmitz, H.R. Wigand, and W. Heinrich. 1983. Worldwide epidemiology of human Adenovirus infections. Am. J. Epidemiol. 117: 455.466
3. Uhnon, L, G. Wadell, L. Svensson and M. E. Jobansson. Importance of enteric Adenoviruses 40 and 41 in acute gastroenteritis in infants and young children. J. Clin. Microbiol. 20,365-372 (1984)
4. Cubit.@ W.D.: Rotavirus Infection: An Unexpected I-Iazard in Unit,-, Caring for the Elderly.Geriatric Medicine Today 1,33.38 (1982),
5. Rung, T., Wang, Ch., Fang, Z, Chou, Z, Chsing, X, Liong, X, Chen, G., Yoo, Chaon T., Ye, W., Den, S. and Chang, W.: Waterbome outbreak of Rotavirus Diarrhoea in Adults in China caused by a Novel Rotavirus. Lancet, 1139-1142 (1984),
6. Cukor, G., Perron, D.n Hudson, R. and Blacklow, N. R. : Detection of Rotavirus in Human Stools by Using Monoclonal Antibody. J. Clin. Microl. 19, 888.892 (1984).,
7. Staider, H. C. Rierhozer, and n N. Oxman. 1977. New human Adenovirus (candidate Adenovirus type 35) causing natal disseminated infection in a renal transplant recipient. J. Clin. Microbiol. 6:257. 265,
8. Wishart, P.K.C James, M. S Wishart, and S. Darougar. 1984, Prevalence of acute conjunctivitis caused by Chlamydia, adenovirus and herpes simplex virus in an ophtalmic casualty department. Br. J. Ophtamol. 68- 653-655.

Manufacturer:

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