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Leptospirosis IgG/IgM Rapid Test

This Leptospirosis Rapid Test is a lateral flow immunoassay, used as an aid in the diagnosis of infection with L.interrogans.

Leptospirosis IgG/IgM Rapid Test Cassette

Intended Use

Leptospirosis IgG/IgM Rapid Test Cassette is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies specific to Leptospira interrogans (L.interrogans) in human serum, plasma or whole blood. This Leptospirosis rapid test kit is intended to be used as a blood screening test device, and as an aid in the diagnosis of infection with L.interrogans.

Suitable for POCT Use

This Leptospirosis rapid test kit can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment within 15 minutes, which makes this test kits very suitable to be used in Point of Care Test (POCT) environment.

Reagents Used

Leptospirosis IgG/IgM Rapid Test cassette consists of: 1) a colored conjugate pad containing recombinant L.interrogans antigens conjugated with colloid gold and rabbit IgG-gold conjugates; 2) a nitrocellulose membrane strip containing two test bands: one band is pre-coated with monoclonal anti-human IgM for the detection of L.interrogans IgM antibody, the other band is pre-coated with reagents for the detection of anti-L.interrogans IgG; and 3) the C band is pre-coated with goat anti rabbit IgG.

Leishmaniosis Disease

Leptospirosis, also called Weil's disease, occurs worldwide, and is a common mild to severe health problem for humans and animals, particularly in areas with a hot and humid climate. The natural reservoirs for leptospirosis are rodents and domesticated mammals. L.interrogans is usually transmitted to humans through contact with urine of infected animal, either directly or in water. It can also invades directly through broken skin.

After infection, leptospires are present in the blood until they are cleared after 4 to 7 days by the anti-L.interrogans antibodies, initially the IgM class, then the IgG class. Serological detection of anti-L.interrogans antibodies is a common diagnostic method used in the diagnosis of Leptospirosis.

Leptospirosis Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
LEPT 481 Leptospirosis IgG/IgM Test serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
How to Use

Leptospirosis IgG/IgM Test

General Information

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

Catalog No.:LEPT 481
Description:Leptospirosis IgG/IgM Test
Category:Arthropod Borne Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
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;
  • Specimen Diluents;
  • Instruction leaflet.

Specimen

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.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

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/WB/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