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Toxo IgG/IgM Rapid Test CE Marking


Product Number: RAPG-TOXO-001

Pack size

20 tests

Product Description

The Biopanda Toxo IgG/IgM Rapid Test detects and differentiates between IgG IgM for Toxoplasma gondii in human serum and plasma samples. This test applies lateral flow immuno-chromatography and is a tool to assist in the diagnosis of infection with T.gondii.

Test Attributes

  • Serum, or plasma may be used for testing
  • Results available in only 15 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose T. gondii infections

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing. Ensure the specimen is mixed well.
  2. Open the foil wrapped pouch and remove the cassette. Use the test as soon as possible or within one hour of opening.
  3. Transfer sample to the specimen well of the cassette, then add buffer and start the timer.
  4. Read the results at 15 minutes once the coloured line(s) have appeared. Results read after 20 minutes are considered invalid.
Toxo IgG/IgM Rapid Test Toxo IgG/IgM Rapid Test

Principle

The Biopanda Toxo IgG/IgM Rapid Test Cassette is a lateral flow immuno-chromatographic assay. The test consists of: 1) a red coloured conjugate containing recombinant T. gondii antigens conjugated with colloid gold (T. gondii conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with monoclonal anti-human IgM for detection of IgM anti-T. gondii, T2 band is pre-coated with reagents for detection of IgG anti-T. gondii, and the C band is pre-coated with goat anti rabbit IgG.

When an adequate volume of test specimen is applied into the sample pad of the test, the specimen migrates by capillary action across the strip. IgM anti-T. gondii if present in the specimen will bind to the T. gondii conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a red coloured T1 band, indicating a T. gondii IgM positive test result.

IgG anti-T. gondii if present in the specimen will bind to the T. gondii conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a red coloured T2 band, indicating a T. gondii IgG positive test result.

Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a red coloured band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the colour development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

Performance Characteristics

Toxo IgG Test
  • Relative sensitivity: 92.6%
  • Relative specificity: 99.0%
  • Accuracy: 97.8%
Toxo IgM Test
  • Relative sensitivity: >99.9%
  • Relative specificity: 99.5%
  • Accuracy: 99.6%

Storage Conditions

+ 2 - 30 °C


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