PRODUCT

ELI.H.A Toxo

Indirect hemagglutination test for serodiagnosis of toxoplasmosis.

ELI.H.A Toxo enables the quantitative determination, by indirect hemagglutination, of serum antibodies (IgG and/or IgM) present in patients suffering from toxoplasmosis (Toxoplasma gondii).

Results in International Units
Liquid ready-to-use reagents
Cost-effective test
High sensitivity and specificity
Fast results for clinicians (2 hours)
Simple visual reading, without expert interpretation

Reference	Name	Quantity
66610	ELI.H.A Toxo	120 tests

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BENEFITS

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Benefits

Intended use

Toxoplasmosis is a parasitic disease caused by the protozoan Toxoplasma gondii. Benign or asymptomatic in most of cases, it presents a serious risk for pregnant seronegative women and subjects with a weakened immune system. ELITech developed the ELI.H.A Toxo, an indirect hemagglutination assay, for the quantitative determination of anti- Toxoplasma gondii antibodies (IgG and/or IgM) in the serum. It is rapid, easy-to-use and easy-to-read with results available within 2 hours and reliable overnight.

Principle

Sheep red blood cells are sensitized with Toxoplasma gondii antigen. IgM as well as lgG antibodies are detected by this technique. They can be differentiated by treating serum with 2-mercaptoethanol (2-ME), which inhibits the agglutinating power of IgM. Diluted serum is mixed with sensitized sheep red blood cells. If anti- Toxoplasma gondii antibodies are present in the serum, sensitized red blood cells will agglutinate, resulting in a cloudy red/brown deposit coating the well. In the absence of specific antibodies, sensitized red blood cells will not agglutinate, resulting in a ring-like deposit at the bottom of the well. Non-sensitized red blood cells are also available in the kit. They ensure the specificity of the reaction by allowing identifying any interference from the natural anti-sheep agglutinins (Forssman heteroantibodies, infectious mononucleosis antibodies…). The reaction is carried out in a U-microplate. Each kit allows 120 tests to be carried out or 20 reactions of 6 dilutions. Results are obtained within 2 hours and are reliable overnight.

Simple Protocol

A single protocol for all our ELI.H.A kits.

First serum dilution
Micrplate preparation
Serial dilution of serum and preparation of the ‘serum control’ well
Addition of sensitized RBC and non sensitized RBC
Gently mix the plate and let stand 2 hours before readingo

The following procedures are therefore valid for all our ELI.H.A range:

Easy-to-read and easy-to-interpret result

Titer	Interpretation
<1:80	NEGATIVE REACTION No anti-toxoplasma antibodies or non-detectable amount. Screening test: probably non-immune patient requesting a serological follow-up for pregnant women. In case of potential acute infection: no toxoplasma infection or very recent beginning infection. Sample should be controlled with a 2^nd sample to detect a possible appearance of antibodies.
1:80≤T≤1:160	Doubtful reaction Presence at a border-line level of anti-Toxoplasma gondii antibodies. Screening test: result to be interpreted according to the results obtained with other Toxoplasmaserology assays. If necessary control with a 2^nd sample. In case of potential acute infection or follow-up of non-immunized pregnant women: Suspicion of a current toxoplasmosis infection. Test for anti-Toxoplasma gondii IgM. It is recommended to control the result with a 2^nd sample collected 15-21 days later.
≥1:160	POSITIVE REACTION Presence of anti-Toxoplasma gondii antibodies. Screening test: Probably a past infection (residual antibodies). In case of potential acute infection or follow-up of non-immunized pregnant women: Probably an acute toxoplasmosis infection. Test for anti-Toxoplasma gondii IgM and control the result with a 2^nd sample.

Reagents and material

Quantity	Description
1	R1: Vial of 2.4 mL of sensitized red blood cells
1	R2: Vial of 1mL of non-sensitized red blood cells
1	BUF: Vial of 55 mL of phosphate buffer pH 7.2
1	R3: Vial of 2 mL of adsorbent
1	CONTROL +: Vial of 0.2 mL of titrated positive control
1	CONTROL -: Vial of 0.2 mL of negative control
2	MICROPLATE: Microplate with a U-bottom
2	DROPPER: Special dropper

Material required but not supplied

Automatic pipette(s) with a pipetting volume adapted to the volume that will be measured
Contaminated waste containers
Centrifuge
Hemolysis tubes
2- mercaptoethanol (2-ME)

Stability and storage

The reagents are liquid and 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 24 months at 2-8°C from its manufacture.

Performances

Sensitivity	Specificity
99.2%	97.7%

Manufacturer: ELITech Microbio.
Product(s) intended for healthcare professionals.
Read the instructions on the label and/or instructions for use of the product(s).

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