Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

A rapid test for the qualitative detection of IgG and IgM antibodies to Leishmania in human’s whole blood, serum or plasma specimen.
For professional in vitro diagnostic use only. 

Application:

The Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Leishmania in human’s whole blood, serum or plasma.

Description:

Visceral leishmaniasis, or Kala-azar, is a disseminated infection caused by several subspecies of the L. donovani. The disease is estimated by the World Health Organization (WHO) to affect approximately 12 million people in 88 countries 1 . It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals. Though it is a disease found in poor countries, in Southern Europe, it has become the leading opportunistic infection in AIDS patients 2-3 . Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the spleen provides a definite mean of diagnosis. Serological detection of anti-L. donovani IgM is found to be an excellent marker for the acute Visceral leishmaniasis. Tests used in clinic are included ELISA, fluorescent antibody or direct agglutination tests 4-5 . Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and specificity dramatically 6-7 .
The Leishmania IgG/IgM Rapid Test Cassette is a recombinant protein based serological test, which detects IgG and IgM antibodies to the L. Donovani simultaneously. The test provides a reliable result within 15 minutes without any instruments.

How to use?

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 μL) to the specimen area, then add 2 drops of buffer (approximately 80 μL),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 40 μL) to the specimen area, then add 2 drops of buffer (approximately 80μL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 40 μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below.
· To use hanging drops: Allow 1 hanging drop of fingerstick whole blood specimen (approximately 40 μL) to fall into the specimen area of test cassette, then add 2 drops of buffer (approximately 80 μL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read the result at 15 minutes, do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS
(Please refer to the illustration above)
IgG POSITIVE: Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the IgG region.
IgM POSITIVE: Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the IgM region.
IgG and IgM POSITIVE: Three distinct colored lines appear. One color line should be in the control region (C) and another two color lines should be in the IgG and IgM region.
NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Leishmania antibodies present in the specimen. Therefore, any shade of red in the test region should be considered positive.
NEGATIVE: One color line appears in the control region (C). No apparent red or pink line appears in the IgG and IgM region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.