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Assay Procedure

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. For Whole Blood, Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of specimen (or approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of buffer for serum or plasma and 2 drops of buffer for whole blood. Start the timer.

For Fingerstick Whole Blood specimens:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 µL (or 2 drops) of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 2 drops of buffer and start the timer.

3. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret results after 30 minutes.

Results

IgMPositive:* The colored line in the control line region (C) appears and a colored line appears in test line region 2 (T2). The result is positive for Leishmania specific‐IgM antibodies.

IgGPositive:* The colored line in the control line region (C) appears and a colored line appears in test line region 1 (T1). The result is positive for Leishmania specific‐IgG.

IgG and IgM Positive:* The colored line in the control line region (C) appears and two colored lines should appear in test line regions 1 and 2 (T1 and T2). The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies.

*NOTE: The intensity of the color in the test line region(s) (T1 and/or T2) will vary depending on the concentration of Leishmania antibodies in the specimen. Therefore, any shade of color in the test line region(s) (T1 and/or T2) should be considered positive.

The colored line in the control line region (C) appears. No line appears in test line regions 1 or 2 (T1 or T2).

Controlline(C) falls toappear.Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure.

Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.