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Principle

It is a qualitative membrane strip based immunoassay for the detection of TOXO antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device
consists of: 1) a burgundy colored conjugate pad containing TOXO recombinant envelope antigens conjugated with Colloid gold (TOXO 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 the antibody for the detection of IgM anti-TOXO, T2 band is coated with antibody for the detection of IgG anti-TOXO, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen isdispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-TOXO, if present in the specimen, will bind to the TOXO conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a TOXO IgG positive test result and suggesting a recent or repeat infection. IgM anti-TOXO if present in the specimen will bind to the TOXO conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a TOXO IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

Test Procedure

Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 80μl) and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Notes:
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of buffer to the specimen well.