Rotavirus Rapid Test Cassette performed within 6 hours after collection.

performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2- 3. As with all diagnostic tests, all results must be interpreted together with other clinical
8°C if not tested within 6 hours. For long term storage, specimens should be kept information available to the physician.
(Feces) below - 20°C. 4. If the test result is negative and clinical symptoms persist, additional testing using other
Package Insert 2. To process fecal specimens: clinical methods is recommended. A negative result does not at any time preclude the
REF IRO-602 English • For Solid Specimens: possibility of rotavirus infection with low concentration of virus particles.
A rapid, one step test for the qualitative detection of rotavirus in human feces. Unscrew the cap of the specimen collection tube, then randomly stab the specimen 【EXPECTED VALUES】
For professional in vitro diagnostic use only. collection applicator into the fecal specimen in at least 3 different sites to collect The Rotavirus Rapid Test Cassette (Feces) has been compared with latex agglutination
【INTENDED USE】 approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal method, demonstrating an overall accuracy of 97.2%.
The Rotavirus Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the specimen. 【PERFORMANCE CHARACTERISTICS】
qualitative detection of rotavirus in human feces specimens to aid in the diagnosis of rotavirus • For Liquid Specimens: Clinical Sensitivity, Specificity and Accuracy
infection. Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops of the The performance of the Rotavirus Rapid Test Cassette has been evaluated with 501 clinical
【SUMMARY】 liquid specimen (approximately 50 µL) into the specimen collection tube containing the specimens collected from children and young adults in comparison with latex agglutination
Rotavirus is the most common agent responsible for acute gastroenteritis, mainly in young extraction buffer. method. The results show that the relative sensitivity of the Rotavirus Rapid Test Cassette
1
children. Its discovery in 1973 and its association with infantile gastro-enteritis represented a Tighten the cap onto the specimen collection tube, then shake the specimen collection (Feces) is 97.3% and the relative specificity is 97.1%.
very important advancement in the study of gastro-enteritis not caused by acute bacterial tube vigorously to mix the specimen and the extraction buffer. Leave the collection tube Rotavirus Rapid Test Cassette vs. Latex Agglutination
infection. Rotavirus is transmitted by oro-faecal route with an incubation period of 1-3 days. for reaction for 2 minutes. Method Latex Agglutination
Although specimen collections taken within the second and fifth day of the illness are ideal for 3. Bring the pouch to room temperature before opening it. Remove the test cassette from the Total Results
foil pouch and use it as soon as possible. Best results will be obtained if the test is Results Positive Negative
antigen detection, the rotavirus may still be found while diarrhoea continues. Rotaviral Rotavirus
gastroenteritis may result in mortality for populations at risk such as infants, the elderly, and performed immediately after opening the foil pouch. Rapid Test Cassette Positive 251 7 258
immunocompromised patients.2 In temperate climates, rotavirus infections occur mainly in the 4. Hold the specimen collection tube upright and unscrew the tip of the specimen collection Negative 7 236 243
winter months. Endemics as well as epidemics affecting some thousand people have been tube. Invert the specimen collection tube and transfer 2 full drops of the extracted Total Results 258 243 501
reported.3 With hospitalised children suffering from acute entric disease up to 50% of the specimen (approximately 80 µL) to the specimen well (S) of the test cassette, then start the
Relative Sensitivity: 97.3% (95%CI:*94.5%-98.9%)
analysed specimen were positive for rotavirus.4 The viruses replicate in the cell nucleus and timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
Relative Specificity: 97.1% (95%CI:*94.2%-98.8%)
tend to be host species specific producing a characteristic cytopathic effect (CPE). Because 5. Read the results at 10 minutes after dispensing the specimen. Do not read results after
Overall Accuracy: 97.2% (95%CI:*95.4%-98.5%) *Confidence Intervals
rotavirus is extremely difficult to culture, it is unusual to use isolation of the virus in diagnosing 20 minutes.
Precision
an infection. Instead, a variety of techniques have been developed to detect rotavirus in feces. Note: If the specimen does not migrate (presence of particles), centrifuge the diluted sample
Intra-Assay
The Rotavirus Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen
Within-run precision has been determined by using 10 replicates of four specimens: a negative,
qualitative detection of rotavirus in human feces specimen, providing results in 10 minutes. The well (S). Start the timer and continue from step 5 onwards in the above instructions for use.
a low positive, a medium positive and a high positive. The specimens were correctly
test utilizes antibody specific for rotavirus to selectively detect rotavirus from human feces
identified >99% of the time.
specimens.
Inter-Assay
【PRINCIPLE】
Between-run precision has been determined by 10 independent assays on the same four
The Rotavirus Rapid Test Cassette (Feces) is a qualitative, lateral flow immunoassay for the
specimens: a negative, a low positive, a medium positive and a high positive. The specimens
detection of rotavirus in human feces specimens. In this test, the membrane is pre-coated with
anti-rotavirus antibody on the test line region of the test. During testing, the specimen reacts were correctly identified >99% of the time.
with the particle coated with anti-rotavirus antibody. The mixture migrates upward on the Cross-Reactivity
9
membrane chromatographically by capillary action to react with anti-rotavirus antibody on the Cross reactivity with following organisms has been studied at 1.0 x 10 organisms/mL. The
membrane and generate a colored line in the test line region. The presence of this colored line following organisms were found negative when tested with the Rotavirus Rapid Test Cassette
in the test region indicates a positive result, while its absence indicates a negative result. To (Feces).
serve as a procedural control, a colored line will always appear in the control line region Staphylococcus aureus Proteus mirabilis Neisseria gonorrhea
indicating that proper volume of specimen has been added and membrane wicking has Pseudomonas aeruginosa Acinetobacter spp Group B Streptococcus
occurred. Enterococcus faecalis Salmonella choleraesius Proteus vulgaris
【REAGENTS】 Group C Streptococcus Gardnerella vaginalis Enterococcus faecium
The test contains anti-rotavirus antibody coated particles and anti-rotavirus antibody coated on Klebsiella pneumoniae Acinetobacter calcoaceticus Hemophilus influenzae
the membrane. Branhamella catarrhalis [Link] Neisseria meningitidis
【PRECAUTIONS】 Candida albicans Chlamydia trachomatis
• For professional in vitro diagnostic use only. Do not use after expiration date. Interfering Substances
• The test cassette should remain in the sealed pouch until use. The following potentially Interfering Substances were added to Rotavirus negative and positive
• Do not eat, drink or smoke in the area where the specimens or kits are handled. specimens.
• Do not use test if pouch is damaged. Ascoribic acid: 20 mg/dL Oxalic acid: 60 mg/dL Bilirubin: 100 mg/dL
• Handle all specimens as if they contain infectious agents. Observe established precautions Uric acid: 60 mg/dL Aspirin: 20 mg/dL Urea: 2000 mg/dL
against microbiological hazards throughout testing and follow standard procedures for Glucose: 2000 mg/dL Caffeine: 40 mg/dL Albumin: 2000 mg/dL
proper disposal of specimens. 【BIBLIOGRAPHY】
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection 1. WILHELMI I, ROMAN E, SANCHEZ-FAUQUIER A. Viruses causing gastroenteritis. Clin
when specimens are being tested. Microbiol Infect. April. 2003, vol.9:247-262.
• The used test should be discarded according to local regulations. 2. Cubitt, WD (1982) Rotavirus Infection: An Unexpected Hazard in Units Caring for the
• Humidity and temperature can adversely affect results. Elderly. Geriatric Medicine Today 1: 33-38.
【INTERPRETATION OF RESULTS】 3. Hung, T et al (1984) Waterborne outbreak of Rotavirus Diarrhoea in Adults in China caused
【STORAGE AND STABILITY】
(Please refer to the illustration above) by a Novel Rotavirus. Lancet, May 26;1(8387): 1139-1142.
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C).
The test is stable through the expiration date printed on the sealed pouch. The test must POSITIVE:* Two colored lines appear. One colored line should be in the control line region 4. Cukor, G; Perron, DM; Hudson, R and Blacklow, NR (1984) Detection of Rotavirus in
(C) and another colored line should be in the test line region (T). Human Stools by Using Monoclonal Antibody. J. Clin. Microl. 19: 888-892.
remain in the sealed pouch containing desiccant until use. DO NOT FREEZE. Do not use
*NOTE: The intensity of the color in the test line region (T) will vary depending on the Index of symbols
beyond the expiration date.
【SPECIMEN COLLECTION AND PREPARATION】 concentration of rotavirus antigen present in the specimen. Therefore, any shade of color in the
test line region (T) should be considered positive. EU authorized
1. Viral detection is improved by collecting the specimens at the onset of the symptoms. It has Caution Tests per kit
NEGATIVE: One colored line appears in the control line region (C). No line appears in the representative
been reported that the maximum excretion of rotavirus in the feces of patients with
gastroenteritis occurs 3-5 days after onset of symptoms. If the specimens are collected long test line region (T). For in vitro
INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect Use by Do not reuse
after the onset of diarrheic symptoms, the quantity of antigen may not be sufficient to obtain diagnostic use only
a positive reaction or the antigens detected may not be linked to the diarrheic episode. procedural techniques are the most likely reasons for control line failure. Review the procedure
and repeat the test with a new test cassette. If the problem persists, discontinue using the test Store between 2-
2. The feces specimen must be collected in a clean, dry, waterproof container containing no Lot number Catalog #
kit immediately and contact your local distributor. 30°C
detergents, preservatives or transport media.
3. Bring the necessary reagents to room temperature before use. 【QUALITY CONTROL】 Do not use if Consult instructions
An internal procedural control is included in the test. A colored line appearing in the control line Manufacturer
【MATERIALS】 package is damaged for use
Materials provided region (C) is an internal positive procedural control. It confirms sufficient specimen volume,
• Test cassettes • Package insert adequate membrane wicking and correct procedural technique.
• Specimen collection tubes with extraction buffer • Droppers Control standards are not supplied with this kit; however, it is recommended that positive and
Materials required but not provided negative controls be tested as a good laboratory practice to confirm the test procedure and to
• Specimen collection containers • Timer verify proper test performance.
• Centrifuge and pipette to dispense 80 µL if required 【LIMITATIONS】
【DIRECTIONS FOR USE】 1. The Rotavirus Rapid Test Cassette (Feces) is for in vitro diagnostic use only. The test
Allow the test, specimen, buffer, and/or controls to reach room temperature (15-30°C) should be used for the detection of human rotavirus in feces specimens only. Neither the Number: 146887800
prior to testing. quantitative value nor the rate of increase in human rotavirus concentration can be Effective date: 2022-07-29
1. To collect fecal specimens: determined by this qualitative test.
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection 2. The Rotavirus Rapid Test Cassette (Feces) will only indicate the presence of rotavirus in
container to obtain enough virus particles. Best results will be obtained if the assay is the specimen and should not be used as the sole criteria for the conforming rotavirus to be
etiological agent for diarrhea.