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Test kit is created for the qualitative detection and differentiation of Toxoplasma specific IgG and IgM antibodies in human serum, plasma, and whole blood samples.
【INTENDED USE】
The TOXO IgG/IgM Rapid Test Kit is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-Toxoplasma gondii in human whole blood, serum or plasma.
【CONTENTS】
• Rapid Test.
• Buffer
• Disposable pipettes
• Instruction for use.
【OPERATION】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label thedevicewithpatient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 2 drops of serum or plasma specimentothespecimenwell (S) of the device and start the timer. OR Transfer 1 drop of whole blood specimen to the specimen well (S) of the device with the provideddisposable pipette, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solutiontotheresultwindow. As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read.
【INTERPRETATION OF RESULTS】
Negative (-) : Only one color line appears on the control region (C).
Positive (+) : IgG Positive: Both IgG test region (G) and control region appear color line.
IgM Positive: Both IgM test region (M) and control region appear color line.
IgG/IgM Positive: Both test region (G and M) and control region appear color line.
Invalid: No visible line at all, or there is a visible line only in the test region and not in the control region. Repeat with a new test kit.