High Sensitivity Toxo IgM Rapid Test Cassette Rapid Test Kits for human whole blood

A rapid test for the qualitative detection of IgM antibody to Toxoplasma Gondii(T.gondii) in human whole blood, serum or plasma CE certified

Applications:

The Toxo IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (T. gondii) in human whole blood, serum or plasma. This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with T. gondii. Any reactive specimen with the Toxo IgM Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.

Description:

T. gondii is an obligate intracellular protozoan parasite with a worldwide distribution^1,2. Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism³. A variety of serologic tests for antibodies to T. gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. These tests are the Sabin-Feldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluorescence, and ELISA^4-7. Recently, lateral flow chromatographic immunoassay, such as The Toxo IgM Rapid Test Cassette was introduced into the clinic for the serodiagnosis of T. gondii infection.

How to use?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

• Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
• Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the specimen (whole blood/serum/plasma) up to the Fill Line as shown in illustration below (approximately 10μl). Transfer the specimen to the specimen well each, then add 2 drops of buffer (approximately 80 μl) and start the timer. See the illustration below.
• Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes .
• 

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the test line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of T.gondii IgM antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.