CE ISO Rotavirus Diagnostic Test with Feces Sample Rapid Test

• Type: IVD Reagent
• Certificate: ISO, CE
• Shelf Life: 24 Months
• Usage: Professional Use
• Sample: Feces
• Result Time: Within 15 Mins
• Model NO.: ROT-DF02
• Principle: Immunochromatography
• Storage: 2~30ºC
• Transport Package: Cartons
• Specification: 25 test/box
• Trademark: Dewei
• Origin: China
• Production Capacity: 100, 000PCS/Day

Product Description

Intended Use

The  Rotavirus  Rapid  Test  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.

 

Contents

• Rapid Test.
• Specimens dilution tube with buffer
• Disposable pipettes
• Instruction for use.

 

Storage & Statibility

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
 

 

Sample Collection&Storage

• The Rotavirus RapidTest 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.
 

Operation

Bring  tests,  specimens,  buffer  and/or  controls  to  room  temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) 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.

2) 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.

3) Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

4) Shake the specimen collection tube vigorously to mix the specimen and theextraction 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.

2. Testing
1) 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.
2) 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.
3)  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 80µL of supernatant, dispense into the specimen well (S) of a new test device and start afresh following the instructions mentioned above.


 

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Company Profile

About Us

Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
 

R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.

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