The Leishmania Ab Rapid Test is a lateral flow immunoassay for the
qualitative detection of antibodies including IgG, IgM, and IgA to
the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans in human serum or plasma. This test is
intended to be used as a screening test and as an aid in the
diagnosis of the disease of Visceral leishmaniasis. Any reactive specimen with the Leishmania Ab Rapid Test must be
confirmed with alternative testing method(s).
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 countries1. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected
animals. Though it is a disease for poor countries, in Southern
Europe, it has become the leading opportunistic infection in AIDS
Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the
spleen provides a definite means of diagnosis. However, these test
methods are limited by the sampling method and the special
instrument requirement. Serological detection of anti-L. donovani Ab is found to be an excellent marker for the infection of Visceral leishmaniasis. Tests used in clinic include: ELISA, fluorescent antibody and
direct agglutination tests4-5. Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and
The Leishmania Ab Rapid Test is a recombinant protein based
serological test, which detects antibodies including IgG, IgM and
IgA to the L. Donovani. This test provides a reliable result within 10 minutes without
any instrumentation requirements.
The Leishmania Ab Rapid Test is a lateral flow chromatographic
immunoassay. The test cassette consists of: 1) a burgundy colored
conjugate pad containing recombinant L. donovani specific antigen conjugated with colloid gold (Leishmania
conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose
membrane strip containing a test band (T band) and a control band
(C band). The T band is pre-coated with un-conjugated L. donovani antigen, and the C band is pre-coated with goat anti-rabbit IgG
When an adequate volume of test specimen is dispensed into the
sample well of the test cassette, the specimen migrates by
capillary action across the cassette. Anti- L. donovani Ab if present in the specimen will bind to the Leishmania
conjugates. The immunocomplex is then captured on the membrane by
the pre-coated antigen, forming a burgundy colored T band,
indicating a L. donovani Ab positive test result.
Absence of the T band 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
the T band. Otherwise, the test result is invalid and the specimen
must be retested with another device.
REAGENTS AND MATERIALS PROVIDED
1.Each foil pouch contains with three items inside:
a. One cassette device.
b. One plastic dropper.
c. One desiccant.
3.One package insert (instruction for use).
MATERIALS REQUIRED AND AVAILABLE FOR PURCHASE
1. Positive Control
2. Negative Control
MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or Timer
WARNINGS AND PRECAUTIONS
· For professional in vitro diagnostic use only.
· Do not use after expiration date indicated on the package. Do not
use the test if its foil pouch is damaged. Do not reuse tests.
· This kit contains products of animal origin. Certified knowledge
of the origin and/or sanitary state of the animals does not totally
guarantee the absence of transmissible pathogenic agents. It is
therefore, recommended that these products be treated as
potentially infectious, and handled observing the usual safety
precautions (do not ingest or inhale).
· Avoid cross-contamination of specimens by using a new specimen
collection container for each specimen obtained.
· Read the entire procedure carefully prior to performing any
· Do not eat, drink or smoke in the area where the specimens and
kits are handled. Handle all specimens as if they contain
infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow the
standard procedures for proper disposal of specimens. Wear
protective clothing such as laboratory coats, disposable gloves and
eye protection when specimens are assayed.
· Buffered Saline contains sodium azide which may react with lead
or copper plumbing to form potentially explosive metal azides. When
disposing of buffered saline or extracted samples, always flush
with copious quantities of water to prevent azide build up.
· Do not interchange or mix reagents from different lots.
· Humidity and temperature can adversely affect results.
· The used testing materials should be discarded in accordance with
local, state and/or federal regulations.
REAGENT PREPARATION AND STORAGE INSTRUCTIONS
All reagents are ready to use as supplied. Store unused test
devices unopened at 2°C-30°C. The positive and negative controls
should be kept at 2°C-8°C. If stored at 2°C-8°C, ensure that the test device is brought to
room temperature before opening. The test device is stable through
the expiration date printed on the sealed pouch. Do not freeze the
kit or expose the kit over 30°C.
SPECIMEN COLLECTION AND HANDLING
Consider any materials of human origin as infectious and handle
them using standard biosafety procedures.
1. Collect blood specimen into a lavender, blue or green top
collection tube (containing EDTA, citrate or heparin, respectively
in Vacutainer®) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma into new pre-labeled tube.
1. Collect blood specimen into a red top collection tube
(containing no anticoagulants in Vacutainer®) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum into a new pre-labeled tube.
1. Drops of whole blood can be obtained by either finger tip
puncture or veinpuncture. Do not use any hemolized blood for
3. Whole blood specimens should be stored in refrigeration
(2°C-8°C) if not tested immediately. The specimens must be tested
within 24 hours of collection.
Test specimens as soon as possible after collecting. Store
specimens at 2°C-8°C if not tested immediately.
Store specimens at 2°C-8°C up to 5 days. The specimens should be
frozen at -20°C for longer storage.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen
specimens to room temperature slowly and mix gently. Specimens
containing visible particulate matter should be clarified by
centrifugation before testing. Do not use samples demonstrating
gross lipemia, gross hemolysis or turbidity in order to avoid
interference on result interpretation.
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