* For research use only, not for use in diagnostic procedures.
The Leptospira IgG/IgM Colloidal Gold Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with L. interrogans. Any reactive specimen with the Leptospira IgG/IgM Combo Rapid Test must be confirmed with alternative testing method(s).
The Leptospira IgG/IgM Colloidal Gold Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant L. interrogans antigens conjugated with colloidal gold (Leptospira conjugates) and rabbit IgG-gold conjugates; 2) a nitrocellulose membrane strip containing two test lines (M and G lines) and a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection of anti-L. interrogans IgM, G line is pre-coated with reagents for the detection of anti-L. interrogans IgG, and the C line is pre-coated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. IgM anti-L. interrogans, if present in the specimen, will bind to the Leptospira conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody forming a burgundy colored M line, indicating a L. interrogans IgM positive test result. IgG anti-L. interrogans, if present in the specimen, will bind to the Leptospira conjugates. The immunocomplex is then captured on the membrane by the pre-coated reagents forming a burgundy colored G line, indicating a L. interrogans IgG positive test result.
Absence of any test lines (M and G) suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugates regardless of color development on any of the test lines. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.
Leptospirosis occurs worldwide and is a common mild to severe health problem for humans and animals, particularly in areas with hot and humid climates. The natural reservoirs for leptospirosis are rodents as well as a large variety of domesticated mammals. Human infection is caused by L. interrogans, the pathogenic member of the genus of Leptospira 1,2. The infection is spread via urine from the host animal. After infection, leptospires are present in the blood until they are cleared approximately 4 to 7 days after the onset of the disease following the production of anti-L. interrogans antibodies, initially of the IgM class. Culture of the blood, urine and cerebrospinal fluid is an effective means of confirming the diagnosis during the 1st and 2nd weeks after exposure. Serological detection of anti-L. interrogans antibodies is also a common diagnostic method. CDIATM Leptospira IgG/IgM Colloidal Gold Test is a simple serological test that utilizes antigens from L. interrogans and detects IgG and IgM antibodies to these microorganisms simultaneously. The test can be performed by untrained or minimally skilled personnel without cumbersome laboratory equipment, and the result is available within 15 minutes.