J. Mitra Leptospira IGM IgG Card

Rapid Diagnostic test for the detection of Leptospira specific IgM & IgG antibodies in Human Serum/Plasma 

Intended useAdvantage Leptospira IgM & IgG Card is a visual, rapid, sensitive, qualitative immnunoassay for the detection of Leptospira specific IgM and IgG antibodies in human serum or plasma.

Introduction
Leptospirosis is a world-wide occuring zoonotic disease, caused by infection with pathogenic spirochetes of the genus Leptospira. Although traditionally considered as an occupational risk among persons exposed to contaminated water or infected animal urine, leptospirosis is becoming recognised as a common cause of febrile illness in tropical environmments world-wide. The organism enters the human body through cuts or abrasions on the skin or through intact mucosa of the mouth, nose or conjunctiva. The clinical manifestations of leptospirosis range from a mild catarrh like fever, chills, nausea, muscle aches to icteric disease such as Weil’s syndrome, which are charaterized by renal failure, liver impairments & haemorrhages and have a high mortality rate. As clinical symptoms & signs of this infection resemble those of many other infectious diseases including Viral haemorrhage fever and Dengue fever, clinical findings need to be confirmed by laboratory diagnostic techniques.

Principle
(Antigen-antibody reaction) Advantage Leptospira IgM & IgG Card is based on immunochromatographic assay principle. The test uses monoclonal anti-human IgM antibody (test line M) and monoclonal anti-human IgG (test line G) immobilised on a nitrocellulose strip. The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the conjugate. The conjugate contains colloidal gold conjugated to leptospira antigen which is prepared from culture of micro-organisms. If the sample contains Leptospira specific IgM and/or IgG antibodies, it forms a complex with the leptospira antigen gold conjugate making antigen antibodies complex. This complex then migrates through the nitrocellulose membrane by caplillary action. When the complex meets the line of immobilized monoclonal antibodies (Test line, ‘M & G’), it generates a red line, indicating that the sample is reactive. A red procedural control line should always develop at ‘C’ region to indicate that the test has been performed properly.