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LEPTO IgM MICROLISA

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INTENDED USE

LEPTO IgM MICROLISA is designed for in-vitro qualitative detection of Leptospira IgM in human serum or plasma and it is used as a screening test for testing of collected blood samples suspected for Leptospirosis.

SALIENT FEATURES

  • Based on Indirect Elisa principle
  • Colour coded reagents to monitor procedural steps
  • Test procedure: 90 mins
  • Longer Shelf life: 12 months at 2-8°C
  • Excellent Sensitivity 99.62% & Specificity 99.92%
  • Unique break-away wells
  • Easy to use on automated & semi automated processor
LEPTO IgM MICROLISA test is an enzyme immunoassay based on "Indirect ELISA". Recombinant proteins mixture of various molecular weights representing immunodominant epitopes are coated onto microtiter wells. Specimens and controls are added to the microtiter wells and incubated. IgM antibodies to Leptospira if present in the specimen, will bind to the specific antigens absorbed onto the surface of the wells. The plate is then washed to remove unbound material.Horsradish peroxidase (HRPO) conjugated Anti-human IgM is added to each well. This conjugate will bind leptospira antigen-antibody complex present. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated. A blue colour will develop in proportion to the amount of leptospira antibodies present in the specimen. The colour reaction is stopped by a stop solution. The enzyme substrate reaction is ready by EIA reader for absorbance at a wavelength of 450 nm. If the sample does not contain leptospira antibodies then enzyme conjugate will not bind and the solution in the wells will be either colourless or only a faint background colours develops.
ORDERING INFORMATION
PRODUCT NAME PACK SIZE CATALOG NO.
LEPTO IgM MICROLISA 48 Tests IR026048

PERFORMANCE CHARACTERISTICS (IN HOUSE EVALUATION) OF LEPTO IgM MICROLISA
No. of Samples Status LEPTO IgM MICROLISA
    Positive Equivocal Negative
265 Lepto Positive 264 0 1
2650 Lepto Negative 1 1 2648

Sensitivity- 99.62% Specificity-99.92 %

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