Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum or plasma Storage : 2-8 C Cat No : E0330 The RecombiLISA Leptospira IgM ELISA Kit is an indirect, solid phase enzyme-linked immunosorbent assay. The two main kit components are: 1) A 96 breakable well plate with the solid microwells pre-coated with L. interrogans antigen. 2) Liquid conjugates composed of monoclonal anti-human IgM reagent conjugated with horseradish peroxidase (HRP-anti-human IgM conjugates). This test is intended to be used for the qualitative detection of IgM anti-Leptospira interrogans (L. interrogans) in human serum or plasma. It is intended to be used by professionals as an aid in the diagnosis of acute infection with L. 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. Recommended for use: Any person presenting with clinical signs or symptoms consistent with acute infection with interrogansincluding: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash After exposure to a known contaminated source Product Features : Sensitivity: 86.7% Specificity: 96.8% Cross Reactivity: No false positive results were observed on specimens from Dengue, Malaria, Typhi, ANA, HAMA, RF, HIV, HBsAg, HCV, Syphilis, pylori Interference: No interference was seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 1.3 %;Heparin: 3,000 U/L; Creatinine: 5 mmol/L; Bilirubin: 10 mg/dL; EDTA: 3.4 �µmol/L Shelf life: 12 months Open vial stability: 8 weeks at 2-8 C, or until the expiration date Kit Components : Microwells coated with recombinant L. interrogans antigens Lepto IgM positive control Lepto IgM negative control Sample diluent HRP anti-human IgM conjugate Wash buffer (30 x concentrate) TMB substrate A TMB substrate B Stop solution ELISA Working Sheet Product insert