Leishmania IgG/IgM Rapid Test

Leishmania IgG/IgM Rapid Test (利氏曼虫IGG/IgM抗体检测试纸卡) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Indirect principle, which is used to detect IgG/IgM antibodies to Leishmania in human Serum or Plasma specimen.

Please refer to the Instruction for Use (IFU) of the Leishmania IgG/IgM Rapid Test. (For reference only; Read the package insert in the test kit before performing any test.)

Detailed information of Leishmania IgG/IgM Rapid Test

  1. General and Technical information of this LEISH test kit;
  2. Packing specification of this LEISH Card style test kit (gross weight in full kit package and in bulk packing);
  3. Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
  4. Specific immuno assay principle used in this Leishmania Test Kit.

Main technical information of this Leishmania IgG/IgM test kit is listed in the following table:

Catalog No.:LEISH 471
Description:Leishmania IgG/IgM Rapid Test
Category:Arthropod Borne Disease
Style:Card
Unit:PCS
Specimen:Serum, Plasma
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Assay Principle:Colloidal Gold Chromatographic Immuno Indirect

The standard kit size of this Leishmania Card test kit is 25 tests per box; 40 boxes per carton.

To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.


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

Materials Provided

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

To carry out the assay with a Leishmania IgG/IgM Rapid Test, Serum or Plasma should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.

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.

Colloidal Gold Chromatographic Immuno Indirect method is used in this Leishmania IgG/IgM Rapid Test to detect the IgG/IgM antibodies to Leishmania in human Serum or Plasma specifically. The introduction of this Colloidal Gold Chromatographic Immuno Indirect testing principle is given blow.

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.