CTK Biotech, USA Leptospira IgM ELISA Kit 96 Test
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
- 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
- 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
The RecombiLISA Leptospira IgM ELISA Kit is a solid phase enzyme linked immunosorbent assay based on the principle of the indirect immunoassay technique for the qualitative detection of IgM anti-L. interrogans in human serum or plasma. The RecombiLISA Leptospira IgM ELISA Kit is composed of two key components: 1) 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). During the assay, the test specimen is firstly incubated with the coated microwells. The IgM anti-L. interrogans, if present in the specimen, reacts to the antigen coated on the microwell surface. In the second incubation with the HRP-anti-human IgM conjugates, the IgM anti-L. interrogans antibody adsorbed on the surface of the microwells reacts to the conjugates, forming an immunocomplex. Unbound conjugates are then removed by washing. The presence of the conjugate complex is shown by development of a blue color upon additional incubation with TMB substrate. The reaction is stopped with Stop Solution and the absorbance is determined using a spectrophotometer at 450/620-690 nm. OD values must be measured within 5 minutes after the addition of the Stop Solution
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