ELITex Bicolor Amoeba

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Latex slide agglutination test for the detection of amoebic antibodies in serum.

ELITex Bicolor Amoeba is a slide agglutination test for the rapid detection of serum amoebic antibodies present in patients suffering from amoebiasis (Entamoeba histolytica).

  • Cost-effective, routine laboratory test
  • Easy and ready-to-use
  • High sensitivity and specificity
  • Fast results for clinicians (5 min)
  • Simple visual reading, without expert interpretation

Catalogue Number(s)

66608
Product Description: ELITex Bicolor Amoeba
Number of Tests: 25 Tests

Intended use

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.


Principle

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

Result Interpretation
+: 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

 

elitex_bicolor_amoeba_results[1]

Reagents and Material

  • TEST LATEX:
    Vial of 0.5 mL of sensitized latex
    Quantity: 1CONTROL +:
    Vial of 0.5 mL of positive control
    Quantity: 1
  • 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
    Quantity: 4
  • STICK:
    Disposable mixing sticks
    Quantity: 25
  • DROPPER:
    Special dropper
    Quantity: 1

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.

Performance

  • 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
  •   Pasteur pipette or wire loop
  •   Contaminated waste container