One Step Rotavirus Cassette Rapid Test Diagnostic By Feces Stool

Onse Step Rotavirus Rapid Test Diagnostic Kit By Feces Stool

INTENDED USE

The Rotavirus Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of rotavirus in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of rotavirus infection.

INTRODUCTION

Rotavirus is the most common agent responsible for acute gastroenteritis, mainly in young children. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advancement in the study of gastro-enteritis not caused by acute bacterial infection. Rotavirus is transmitted by oro-faecal route with an incubation period of 1-3 days. Although specimen collections taken within the second and fifth day of the illness are ideal for antigen detection, the rotavirus may still be found while diarrhoea continues. Rotaviral gastroenteritis may result in mortality for populations at risk such as infants, the elderly, and immunocompromised patients. In temperate climates, rotavirus infections occur mainly in the winter months. Endemics as well as epidemics affecting some thousand people have been reported. With hospitalised children suffering from acute entric disease up to 50% of the analysed specimen were positive for rotavirus. The viruses replicate in the cell nucleus and tend to be host species specific producing a characteristic cytopathic effect (CPE). Because rotavirus is extremely difficult to culture, it is unusual to use isolation of the virus in diagnosing an infection. Instead, a variety of techniques have been developed to detect rotavirus in feces.

SAMPLE COLLECTION 

• The Rotavirus Rapid Test Device (Feces) is intended only for use with human fecal specimens.
• Viral detection is improved by collecting the specimens at the onset of the symptoms. It has 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 after the onset of diarrheic symptoms, the quantity of antigen may not be sufficient to obtain a positive reaction or the antigens detected may not be linked to the diarrheic episode.
• Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
• Bring specimens to room temperature prior to testing.
• Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

• Specimen collection and pre-treatment:

• Use the specimens collection container provided in the kit for specimens collection. Follow the operation procedure written on it for instructions. Other clean dry containers could also be used for the same purpose. Best results will be obtained if the assay is performed within 6 hours after collection.
• For solid specimens: Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).

For liquid specimens: Hold the pipette vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 50 µL) into the specimen collection tube containing the extraction buffer.

• Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
• Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.

• Testing

• Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.
• Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 drops of solution into the specimen well (S) of the test device.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

As the test begins to work, you will see color move across the membrane.

• Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S) of a new test device and start afresh following the instructions mentioned above.

MAIN CONTENTS

Rapid Test Cassette in Pouch

Buffer

Disposable dropper

Package insert

STORAGE

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).

The test is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

DO NOT FREEZE.

Do not use beyond the expiration date.

PERFORMANCE

Relative Sensitivity: 99.1% (96.8%-99.9%)*

Relative Specificity: >99.9% (97.7%-100.0%)*

Overall Agreement: 99.5% (98.1%-99.9%)*

*95% Confidence Interval

For details, please contact Dewei staff for Instruction Manual!