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  • Human Diagnostics
  • Veterinary Diagnostics
  • Genetics Lab

Lomina Toxoplasmosis IgM/IgG Antibody test

The Lomina Toxoplasmosis IgG/IgM Antibody Test is a lateral flow chromatographic test for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (T. gondii) and IgG anti-T. gondii in human whole blood, serum or plasma.

Details

Intended Use:

The Lomina Toxoplasmosis IgG/IgM Antibody Test is a lateral flow chromatographic test for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (T. gondii) and IgG anti-T. gondii in human whole blood, serum or plasma. This kit is intended for use as a screening test and as an aid in the diagnosis of T. gondii infection. Any reactive sample with the Lomina Toxoplasmosis IgG/IgM Antibody Test must be confirmed by alternative test method(s) and clinical findings.

Toxoplasmosis IgG/IgM test:

T. gondii is an obligate intracellular protozoan with a worldwide distribution. According to serological data, approximately 30% of the population of most industrialized countries is chronically infected with this organism. A number of serological tests for antibodies to T. gondii are used to aid in the diagnosis of acute infection and to assess previous exposure to the organism. These tests include the Sabin-Feldman staining test, direct agglutination, indirect haemagglutination, latex agglutination, indirect immunofluorescence and ELISA. More recently, lateral flow chromatographic immunoassays such as the Lomina Toxoplasmosis IgG/IgM Antibody Test have been introduced into clinical practice for the serodiagnosis of T. gondii infection.

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested for the use of blood samples taken from a finger.

Whole blood

Major Parameters, Characteristics & Limits

Test duration: 15 min

IVD category: IVD other

IgM
Sensitivity: 94.00% (95%CI: 83.50%-98.70%)
Specificity: 98.80% (95%CI*: 97.10%-99.60%)
Accuracy: 98.20% (95%CI*: 96.50%-99.20%)

IgG
Sensitivity: 96.00% (95%CI: 86.30%-99.50%)
Specificity: 98.50% (95%CI*: 96.80%-99.40%)
Accuracy: 98.20% (95%CI*: 96.50%-99.20%)

Principle:

The Lomina Toxoplasmosis IgG/IgM Antibody Test is a lateral flow chromatographic test. The test consists of: 1) a red coloured conjugate containing recombinant T. gondii antigens conjugated to colloidal gold (T. gondii conjugates) and conjugates of mouse IgG and gold, 2) a nitrocellulose membrane strip containing two test lines (IgG and IgM lines) and a control line (C line). The IgM line is pre-coated with monoclonal anti-human IgM for the detection of anti-T. gondii IgM, the IgG strip is pre-coated with reagents for the detection of anti-T. gondii IgG and the C line is pre-coated with goat anti-mouse IgG. After applying an adequate volume of test sample to the test pad, the sample migrates through the strip via capillary action. IgM anti-T. gondii, if present in the sample, binds to T. gondii conjugates. The immunocomplex is then captured on the membrane by a pre-coated anti-human IgM antibody and forms a red coloured IgM line, indicating a positive test result for T. gondii IgM. IgG anti-T. gondii, if present in the sample, binds to T. gondii conjugates. The immunocomplex is then captured by pre-coated reagents on the membrane and forms a red coloured IgG line, indicating a positive test result for T. gondii IgG. Absence of T line in the test area indicates a negative result. The test contains an internal control (control area C) which should show a red coloured line of the goat anti-mouse IgG/mouse IgG-gold conjugate immunocomplex, regardless of the development of the colour of either of the IgG or IgM lines. Otherwise, the test result is invalid and the sample must be retested with a different instrument.

Interpretation:

A. Negative test result:

A single coloured line appears in the control area (C). No coloured line appears in the test area (T).

B. Positive test result:

Two/Three coloured lines appear. One colour line should be in the control area (C) and the other colour line should be in the test area IgG or IgM or both. The intensity of the colour in the test area (T) will vary depending on the concentration of Lyme antibodies present in the sample. Therefore, any shade of colour in the test area (T) should be considered positive.

C. Invalid test result:

The control line is not displayed. The most likely cause of control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.

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High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
application

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