Fecal Rotavirus Antigen Rapid Test Kit

Catalog No. ABIN1305184

Product Details

Target: Antigen

Reactivity: Rotavirus

Application: Rapid Test (rapid)

Purpose: The Rotavirus Rapid Test Strip employs dye-conjugated monoclonal antibodies against antigen VP6 of group A of rotavirus, and solidphase specific rotavirus antibodies. In this test the specimen is first treated with an extraction solution to extract rotavirus antigens from the faces. Following extraction, the only step required is to screw the rotavirus test strip into the sample collection device. As the sample extraction flows through chamber and reach the test strip, the colored particles migrate. In the case of a positive result the specific antibodies present on the membrane will capture the colored particles. Different colored lines will be visible, depending upon the virus content of the sample. These lines, after 5 minutes of incubation at room temperature, are used to interpret the result.

Brand: EpiTuub®

Sample Type: Fecal

Analytical Method: Qualitative

Cross-Reactivity (Details): Cross reactivity has been evaluated and found to be negative compared to positive specimens of Cryptosporidium parvum, to the Adenovirus group and to the 40/41 strain of Adenovirus.

Components: 1. Rotavirus test strip 30
2. Fecal sample collection device 30
3. Single use green pipet 30
4. Patient label for sample collection device 30
5. Instruction for use 1

Material not included: 1. Disposable pipette for watery sample collection
2. Positive Control

Application Details

Comment:

Single pouched.

Assay Time: 0.5 h

Protocol: This rotavirus antigen test kit is intended for the direct qualitative detection of the presence of rotavirus antigen in patient fecal samples. The test might be used as an aid for detecting patients with acute gastroenteritis infected with rotavirus. It is for professional use only.

Sample Collection: Stool samples must be taken as soon as the symptoms appear. Viral particles decrease in number after one week, making the diagnosis more difficult. The samples can be stored in the refrigerator for 1 to 2 days. For longer storage they must be kept frozen at -20 °C. In this case, the sample should be totally thawed, and brought to room temperature and homogenized before testing. For each solid specimen: Unscrew the sampling lid and keep the sampling tube in a vertical position to prevent the loss of any extraction solution. Insert and twist the tip of the sampling lid into the stool specimen at two or more different sites. Collect fecal sample that is stuck to the surface of the sampling lid. Do not intentionally collect any separate and large pieces of fecal sample into the tube. Replace the sampling lid into the tube and secure tightly. For each liquid specimen: Unscrew the sampling lid and keep the sampling tube in a vertical position to prevent the loss of any extraction solution. Using the green pipet to collect three drops of the liquid stool sample and add to the sampling tube. Replace the sampling lid into the tube and secure tightly.

Assay Procedure:

1. Bring foil pouch sealed test strips and collected specimens to room temperature (8 - 30 C). 2. Mix the sampling tube vigorously to ensure a good liquid suspension. 3. Position the sampling tube upper side down in vertical and let it sediment for about 1 minute. 4. Remove the test strip from the sealed foil pouch. EDI Kit insert: fecal rotavirus antigen/v7/2012-06 Page 2 of 3 5. Screw the test strip in a vertical position into the sampling tube by breaking into the bottom seal of the sampling tube. Tighten securely! 6. Allow the solution flow into the bottom space of the test strip and keep the device in a vertical position. 7. Read test result at 5 minutes and do not interpret test result after 10 minutes.

Calculation of Results:

1. Valid Test: The appearance of control line on the test reading membrane area indicates the test is valid. The control line located at the upper half of the test membrane area.
   2. Positive: If two red/pink colored bands are visible within 10 minutes, the test result is positive and valid.
   3. Negative: If test area has no colored band and the control area displays a red/pink colored band, the test result is negative (see figure as Valid Test).
   4. Invalid: If a colored band does not form in the control area regardless there is any band in the test area, the test result is invalid.

Restrictions: For Research Use only

Handling

Precaution of Use: The reagents are for professional use only. Source material from which reagents of bovine serum was derived in the contiguous 48 United States. It was obtained only from donor health animals maintained under veterinary supervision and found free of contagious diseases. Wear gloves while performing this test and handle these reagents and patient samples as if they are infectious. Do not get in eyes, on skin, or on clothing. Do not ingest. On contact, flush with copious amounts of water for at least 15 minutes. When the assay procedure is completed, dispose of specimens (biohazard materials) carefully after autoclaving for at least one hour. Alternatively, treat with a 0.5 or 1% solution of sodium hypochlorite for one hour before disposal. Use Good Laboratory Practices.

Storage: 4 °C

Target Details

Target: Antigen

Target Type: Viral Protein

Background: Rotaviruses are the main cause of acute gastroenteritis and diarrhea, especially in children under the age of two years. Rotaviruses have been identified in almost 40 % of the faces of children with gastroenteritis. Rotavirus is the cause of up to 50 % of the hospitalized cases of diarrhea in infant and young children. If not treated, the infection may result in severe dehydration and disorders of body electrolyte balance. Therefore, it can be mortal in risk populations such as children, the elderly or immunosuppressed individuals. Rotavirus is transmitted by oral-fecal contact with an incubation period of 1-3 days. Characteristic symptoms include vomiting, hydrodiarrhoea for between 3 and 8 days, high temperature and stomach pains. A large amount of rotavirus particles is shed during infection. Diagnosis of gastroenteritis with rotavirus infection can be established based on the detection of the virus particles by electron microscopy or the virus antigen by specific immunoassay methods