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Leishmania IgG/IgM Rapid Test

This Leishmania antibody rapid test kit is used as an aid in the diagnosis of Visceral leishmaniasis, A.K.A. Kala-Azar Disease.

Leishmania IgG/IgM Rapid Test Cassette

Intended Use

Leishmania IgG/IgM Rapid Test Kit is a lateral flow immunoassay for the simultaneous detection and differentiation of the IgG and IgM antibodies to the Leishmania donovani (L.donovani) in human serum or plasma. This Leishmania blood test is intended to be used as a blood screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis, A.K.A. Kala-Azar Disease. Any reactive specimen with this Leishmania rapid Test kit must be confirmed with alternative testing method(s) together with other clinical diagnosis.

Reagents Used in the Kit

The Leishmania IgG/IgM Rapid Test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant L.donovani antigen conjugated with colloid gold (Leishmania conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (1 and 2 bands) and a control band (C band). The band 1 is pre-coated with monoclonal anti-human IgM for the detection of anti-L.donovani IgM, band 2 is pre-coated with reagent for the detection of anti-L.donovani IgG, and the C band is pre-coated with goat anti rabbit IgG.

Leishmaniosis Disease

Visceral leishmaniosis, or Kala-azar, is a disseminated infection caused by several subspecies of L.donovani. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals.

Serological detection of anti-L.donovani IgM is found to be an excellent marker for the acute Visceral leishmaniasis. Recently, the adoption of L. donovani specific protein in the serological test method has improved the sensitivity and specificity dramatically.

Leishmania Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
LEISH 471 Leishmania IgG/IgM Rapid Test serum/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
How to Use

Leishmania IgG/IgM Rapid Test

General Information

(IVD Kit »-» Arthropod Borne Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:LEISH 471
Description:Leishmania IgG/IgM Rapid Test
Category:Arthropod Borne Disease
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Method:Lateral Flow Indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Instruction leaflet.


Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum/plasma Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. 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.

Testing Principle of Lateral Flow Indirect

GICA Indirect Method Illustration

In the lateral flow indirect chromatographic rapid test, recombinant or purified antigens are immobilized in the test band region. In the end of the Conjugate pad of the membrane strip where the samples are supposed to be added, rabbit or mouse anti-human IgG antibodies conjugated with colloidal gold particles is embedded.

During the testing process, specimen is added to the end of the membrane strip. anti-IgG colloidal gold particles resolve into the specimen, where the anti-IgG conjugate will react and bound with the target IgG antibody, if present.

This complex of IgG and anti-IgG will move along the membrane strip to the testing band region, under capillary effect, where the immobilized antigen captures the IgG antibody. When the antigen-IgG-Anti-IgG complex accumulate on the test band region, the congregated colloidal gold particle will develop red or pink color, indicating there are target IgG antibodies in the specimen.

If there is no target IgG antibody in the specimen, the secondary anti-IgG conjugate will not bind to the immobilized antigen in the test band region, and no color will develop.

As a procedural quality control, a secondary antibody or recombinant antigen will be immobilized in the control band region. When the specimen climb to this region, the unbound anti-IgG colloidal gold particle will be captured, thus a red band will always develop. This inner control process ensure that enough specimen is added, proper testing procedure has been followed, and the reagent has not deteriorated.

Information | Packing | Specimen | Principle