Amoebiasis is a parasitic infection caused by a protozoon specific to humans: Entamoeba histolytica. It’s the only pathogenic amoeba for humans. Immunological diagnosis, via the detection of antibodies, is highly important to confirm hepatic and pulmonary amoeba infections.
ELITech developed the ELITex Bicolor Amoeba, a slide agglutination test, for the rapid identification of serum amoebic antibodies present in patients suffering from Amoebiasis (Entamoeba histolytica). It is rapid, easy-to-use and easy-to-read with results available within 5 minutes.
The brown TEST LATEX reagent is made up of red dyed latex particles in suspension with a green counter dye. These particles are sensitized with a mixture of Entamoeba histolytica total antigen. The presence of amoebic antibodies in the serum is characterized by a red agglutination, which could progressively spread towards the periphery, on a green background.
In absence of specific antibodies, the suspension remains homogeneous with a uniform brown color.
To validate the assay, positive (CONTROL+ reagent) and negative (CONTROL- reagent) controls are also available in the kit. The controls are ready-to-use and have to be used pure.
An agglutination must be observed with the CONTROL+ reagent and no agglutination must be observed with the CONTROL- reagent. If it is not the case, then the test is not valid.
Each kit allows 25 tests to be carried out. Results are obtained within 5 minutes.
Easy-to-read and easy-to-interpret results
+: Formation of a red agglutination (which can progressively spread towards the periphery) on a green background.
PRESENCE OF AMOEBIC ANTIBODIES
-: Absence of agglutination. The suspension remains homogeneous and brown.
ABSENCE OF AMOEBIC ANTIBODIES Probable absence of amoeba tissue infection
Reagents and Material
TEST LATEX: Vial of 0.5 mL of sensitized latex
Quantity: 1CONTROL +: Vial of 0.5 mL of positive control
CONTROL -: Vial of 0.5 mL of negative control
Quantity: 1DIL: Vial of 5ml of special diluent (dispensing drops of ±40µl)
Quantity: 1TEST CARD: Disposable reaction card
STICK: Disposable mixing sticks
DROPPER: Special dropper
Stability and storage
The reagents are ready-to-use.
All the reagents are stored at 2-8°C. Do not freeze.
The results of the stability study indicate that the product has a stability of 15 months at 2-8°C from its manufacture.
Diagnostic sensitivity: 98%
Diagnostic specificity: 96%
Material required but not provided
Automatic pipette(s) with a pipetting volume adapted to the volume that will be measured