Leptospira rapid diagnostic test is for both present and past infection status, immunoglobulin M (IgM) indicates present history whereas immunoglobulin G (IgG) indicates past as shown above picture. Advantage Lepto IgG/IgM Combo Rapid Test is a visual, rapid, sensitive, qualitative immunoassay for the detection of Leptospira-specific IgM and IgG antibodies in human serum or plasma or whole blood ( CTK, SD BIOSENSOR, Diagnostic Automation Kits). Leptospirosis is an infectious disease. It is a worldwide occurring zoonotic disease and its causative agent is pathogenic spirochetes of the genus Leptospira and species L. interrogans. Mode of infection: Although traditionally considered as an occupational risk among persons exposed to contaminated water or infected animal urine, leptospirosis is becoming recognized as a common cause of febrile illness in tropical environments worldwide. Pathogenesis of leptospirosis: Bacterium enters the human body through cuts or abrasions on the skin or through intact mucosa of the mouth, nose, or conjunctiva. Clinical features: from a mild catarrh like fever, chills, nausea, muscle aches to icteric disease such as Weil’s syndrome, which are characterized by renal failure, liver impairments, and hemorrhages and have a high mortality rate. Sign and Symptoms: Clinical signs and symptoms of this infection resemble those of many other infectious diseases including Viral hemorrhagic fever and Dengue fever, clinical findings need to be confirmed by laboratory diagnostic techniques. This Lepto IgG/IgM Combo Rapid Test is intended to be used as a screening test by professionals and provides a preliminary test result to aid in the diagnosis of infection with Leptospira interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers
Lepto IgG/IgG Combo test is based on the immunochromatographic assay. The test uses monoclonal anti-human IgM antibody (test line M) and monoclonal anti-human IgG (test line G) immobilized 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 a Leptospira antigen which is prepared from the culture of bacteria. 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 capillary action. When the complex meets the line of immobilized monoclonal antibodies ( ‘M & G’), it generates a red/pink line, indicating that the sample is reactive. A red/pink procedural control line should always develop at the ‘C’ region to indicate that the test has been performed properly ( as internal quality control).
IgG test positive: Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the IgG region.
IgM test positive: Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the IgM region.
IgG and IgM test positive: Three distinct colored lines appear. One color line should be in the control region (C) and another two color lines should be in the IgG and IgM region.
Test negative: One color line appears in the control region (C). No apparent red or pink line appears in the IgG and IgM region.
Test invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.