Enssure Leptospira IgG/IgM
Leptospirosis 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 as well as a large variety of domesticated mammals. Human infection is caused by L. interrogans, the pathogenic member of the genus of Leptospira. The infection is spread via urine from the host animal. After infection, leptospires are present in the blood until they are cleared after 4 to 7 days 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 1st to 2nd weeks after exposure. Serological detection of anti-L. interrogans antibodies is also a common diagnostic method. However, all above mentioned methods require a sophisticated facility and well-trained technicians. The Leptospira IgG/IgM is a simple serological test that utilizes antigens from L. interrogans and detects IgG and IgM antibodies to these microorganisms simultaneously.
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LEPTOSPIRA IgG/IgM
Product Information
Intended Use:
The Leptospira IgG/IgM Ab Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Leptospira in human serum/plasma/whole blood specimens.
Principle:
The Leptospira IgG/IgM Ab Rapid Test features three pre-coated lines: "G" for IgG, "M" for IgM, and "C" for control. The test uses a colored conjugate pad containing Leptospira conjugates. When the specimen is added, anti-L. interrogans IgM binds to Leptospira conjugates, forming a colored M line, indicating IgM positivity. Similarly, anti-L. interrogans IgG binds to Leptospira conjugates, forming a colored G line, indicating IgG positivity. Absence of M and G lines suggests a negative result. The control line (C) acts as a procedural control, and its absence renders the test invalid, requiring retesting with another device.
Testing Procedure
Importance to know
Warnings and Precautions
- Please read the instruction carefully before performing the test.
- Do not use the test after the expiration date.
- Immediately carry out the test after removing the test device from the pouch.
- Do not mix or interchange the specimen sample.
Limitation
- The Leptospira IgG/IgM Ab Rapid Test is for in vitro diagnostic use only, detecting antibodies in whole blood, serum, or plasma.
- It provides a qualitative result; neither the concentration nor the rate of increase in Leptospira can be determined.
- A negative result may occur if antibody levels are below detection limits or not present during the disease stage. Use additional clinically available tests for confirmation.