Blue Color Entamoeba Histolytica Rapid Test Cassette With CE Certificate

Blue Color Entamoeba Histolytica Rapid Test Cassette With CE Certificate

Aplication: 

The Entamoeba histolytica Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Entamoeba histolytica antigens in human feces.

Description:

Entamoeba histolytica is an anaerobicparasiticamoebozoan, part of the genus Entamoeba. Predominantly infecting humans and other primates causing amoebiasis,E. histolyticais estimated to infect about 50 million people worldwide. Previously, it was thought that 10% of the world population was infected, but these figures predate the recognition that at least 90% of these infections were due to a second species, E. dispar. Mammals such as dogs and cats can become infected transiently, but are not thought to contribute significantly to transmission. E. histolytica, as its name suggests (histolytic= tissue destroying), ispathogenic; infection can be asymptomatic or can lead toamoebic dysenteryor amoebicliver abscess.

How to use?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8℃ if not tested within 6 hours. For long term storage, specimens should be kept below -20℃.
2. To process fecal specimens:
• For Solid Specimens:
Unscrew the cap of the specimen collection tube,then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
• For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 80μL) into the specimen collection tube containing the extraction buffer.
3. Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for 2 minutes.
4. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
5. Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
6. Read results at 5 minutes after dispensing the specimen. Do not read results after 10 minutes.
7. Note: If the specimen does not migrate, centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80μL of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS 

(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Entamoeba histolytica antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.