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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.
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.
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.
The test is developed and tested for the use of blood samples taken from a finger.
Whole blood
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%)
A single coloured line appears in the control area (C). No coloured line appears in the test area (T).
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.
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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