【Summary and Explanation】

"ImmuneMed Leptospira IgM Duo Rapid" has two IgM interpretation windows. For left window (Epidemic region; specifically P), IgM cut-off titer 50 which is the same in our former Leptospira Rapid Kit (IgM/IgG) is provided. On the other hand, IgM cut-off titer 200 is provided in right window (Endemic region; specifically N), so that we confidently expect our new kits can be used for probable diagnosis at any area in the world. If a sample has positive in P window (left) but negative in N window (right), this sample would be from early Leptospirosis patient who has low MAT titer, past infection, or inapparent infection. Therefore, in this case in endemic region, we recommend do test again within a few days considering the symptom and clinical signs. Additionally, if a sample has positive in both P and N, it means MAT titer is 200 or above, so the rate of correct diagnosis is increased by just one usage of our new kit.

【Principle】

"ImmuneMed Leptospira IgM Duo Rapid" tests is semi-quantitative tests for the antibodies against Leptospira in the patient's plasma, serum or blood using Lateral Flow Immunochromatographic Assay. After applying diluted serum, plasma or whole blood onto the hole of test device, patient's sample first reacts with gold conjugated anti-human IgM antibody. After that, reactant diffuses on the membrane to the Leptospira antigen marked as test line. If positive, the test line turns to red color because antigen-antibody-gold conjugate complex is formed on the test line. This Leptospira IgM Duo Rapid provides not only rapid diagnosis of Leptospirosis among AFI (Acute Febrile Illness) but also partial quantitative detection of IgM antibody as dual levels simultaneously. Furthermore, this kit is easy to handle and provides rapid interpretation of the result with no equipment within 15 minutes.