Leishmania IgG/IgM Rapid Test

Intended Use

Leishmania IgG/IgM Rapid Test (Serum/Plasma) is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM to the subspecies of the Leishmania donovani, the visceral leishmaniasis causative protozoans, in human serum or plasma specimens. The product may be used as an aid in the diagnosis of the disease of visceral leishmaniasis. Testing results should be confirmed by other supplemental assay(s).

What is the principle of the Leishmania IgG/IgM Rapid Test?

Leishmania IgG/IgM Rapid Test detects IgG and IgM antibodies specific for leishmania through visual interpretation of color development on the internal strip. Anti-human IgG antibody and anti-human IgM antibody are immobilized on the test regions of the membrane. \

When specimen and then buffer is added to the sample well on the test panel, specific antibodies, if present, will bind to the recombinant L. donovani antigens conjugated to colored particles on the sample pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgG antibody and/or anti-human IgM antibody immobilized at the detection zone. Colored bind(s) will form at the test region(s). The presence of colored band(s) indicates a positive result, while its absence indicates a negative result.

As liquid continues to migrate down the test strip, the control line appears. The appearance of this colored band at the control region serves as a procedural control, indicating the membrane wicking has occurred.

Materials

● Test devices

● Droppers

● Buffer

● Package insert

Test Procedure

Bring the test device, buffer and specimen to room temperature (15-30°C) prior to testing.

1. Remove the test device from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.

2. Place the test device on a clean, level surface. Label with specimen ID.

Using the provided disposable dropper, draw the specimen up to the Fill Line, and transfer serum/plasma (approximately 5 uL), to the sample well (S), then add 3 drops of buffer and start the timer.

Avoid trapping air bubbles in the sample well (S), and do not add any solution to the result area.

3. Wait for the colored band(s) to appear. Read results at 15 minutes.

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