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SERELISA® | ParaTB Ab Mono Indirect

Mycobacterium Avium Subspecies Paratuberculosis Antibody Test Kit

DETECT JOHNE’S DISEASE WITH CONFIDENCE IN CATTLE AND GOAT HERDS

SERELISA® ParaTB Ab Mono Indirect is an enzyme-linked immunosorbent assay (ELISA) test kit licensed for the detection of Mycobacterium avium subspecies paratuberculosis specific antibodies in bovine serum and plasma and caprine serum (Johne’s disease).

SERELISA ParaTB Ab Mono Indirect PROVIDES:

  • Excellent plate-to-plate consistency1
  • 480 wells per kit/up to 460 tests
  • Fast results—approximately 75 minutes
  • Easy-to-use testing method
  • Convenience—90-day stability once plate pouch opened2 and 2-hour stability for diluted conjugate3
References:
1. Data on file, Mycobacterium Paratuberculosis Antibody Test Kit–Product Improvement Validation Report Amendment, Zoetis Inc.
2. Data on file. Study Report No. D830Z-US-14-017, Zoetis Inc.
3. Data on file. Study Report No. D830Z-US-14-019, Zoetis Inc.
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  • SERELISA ParaTB Ab Mono Indirect

    SERELISA ParaTB Ab Mono Indirect is an enzyme-linked immunosorbent assay (ELISA) test kit licensed for the detection of Mycobacterium avium subspecies paratuberculosis-specific antibodies in bovine serum and plasma and caprine serum (Johne’s disease).

    SENSITIVITY DATA IN GOATS1

    SERELISA ParaTB Ab Mono Indirect was compared to necropsy (reference standard) along with three other tests.

    Test Sensitivity (95% CI)
    SERELISA ParaTB Ab Mono Indirect (serum) 55.7% (43.3%-67.6%)
    ParaCHEK®* (serum) 52.9% (40.6%-64.9%)
    AGID (serum) 24.3% (14.8%-36.0%)
    PCR (feces) 87.1% (77.0%-93.9%)
    Goat serum samples obtained through a vaccine effi cacy study and challenged with a bovine isolate of M. avium ss paratuberculosis (n = 70).
    *ParaCHEK (Biocor Animal Health, Nebraska) was USDA-approved for use with goat sera at the time of this study but is no longer available for sale.

    TEST SENSITIVITY BY MONTH1

    Sensitivity

    SPECIFICITY DATA IN GOATS2

    Goat serum samples, from 2 different herds, infection-negative for MAP obtained from the University of Georgia (n=98).

    • Specificity: 100% (95% CI: 97.5% - 100%)
    • Animals confirmed negative through culture and/or Polymerase Chain Reaction (PCR)

    SENSITIVITY AND SPECIFICITY DATA IN CATTLE3

    SERELISA ParaTB Ab Mono Indirect results compared to the known designation of the herds from which these samples originated (no comparison to competitor tests).

    RESULTS:

    Sensitivity: 90.0% (95% CI: 77.95%-96.53%)

    • (Sensitivity: Positive herd serum samples (n = 30) and National Veterinary Services Laboratory
    • (NVSL) positive serum samples [n = 10])
      • Positive herd samples—sourced from a single herd with extended history of Para TB-infected cattle (confirmed through fecal culture and PCR)

    Specificity 99.6% (95% CI: 98.31%-99.97%)

    • (Specificity: Negative herd serum samples [n = 275])
    PROTOCOL OVERVIEW:

    Fast Results

    • Test results in approximately 75 minutes
    • Perform 92 tests per plate

    Easy-to-Use Testing Method

    References:
    1. White R, Marotti KR, Hines ME II, et al. Evaluation of a new enzyme-linked immunosorbent assay (ELISA) for Johne’s disease in goat serum. SOJ Vet Sci. 2016;2(1):1-6.
    2. Data on file. Study Report No. D8K0Z-US-15-001, Zoetis Inc.
    3. Data on file, Mycobacterium Paratuberculosis Antibody Test Kit—Product Improvement Validation Report Amendment, Zoetis Inc.
  • SERELISA® PARA TB MONO INDIRECT

    Mycobacterium avium subspecies paratuberculosis Antibody Test Kit

    The principle of the test is as follows: Serum obtained from bovine and goat herds exposed to ParaTB antigens can contain specific ParaTB antibodies. Serum, diluted in Sample Diluent (containing Mycobacterium phlei extracts), is added to antigen-coated wells. Specific antibody in the serum forms an antibody-antigen complex with the antigen bound to the well. After washing, a monoclonal antibovine IgG HRP conjugate is added to each well. The antibody-antigen complex remaining from the previous step binds with the conjugate. After a brief incubation period and a second wash, any unbound conjugate is removed. Substrate, which contains a chromagen (ABTS), is added to each well. Chromagen color change (from clear to green-blue) occurs in the presence of the HRP enzyme. After the substrate has incubated, Stop Solution is added to each well to terminate the reaction, and the plate is read using an ELISA plate reader at 405-410 nm. The relative intensity of color developed in 15 minutes (compared to controls) is directly proportional to the level of antibody in the serum.

  • Description:
    An enzyme-linked immunosorbent assay (ELISA) test kit for the detection of Mycobacterium avium subspecies paratuberculosis specific antibodies in bovine serum and plasma and caprine serum

    Antibodies Detected:
    Mycobacterium avium subspecies paratuberculosis (ParaTB)

    Use Situations:
    For screening and detection of Johne’s disease

    Sampling:
    5 μL of cattle plasma or serum or caprine serum is used for testing

    Performance:
    In cattle1
    Sensitivity 90.0% (95% CI: 77.95-96.53%)
    Specificity 99.6% (95% CI: 98.31-99.97%)

    In goats2,3
    Sensitivity: 55.7% (95% CI: 43.3%-67.6%)2
    Specificity: 100% (95% CI: 97.5%-100%)3

    Test Time:
    Results available in approximately 75 minutes

    Packaging:
    480 single-well reactions for up to 460 test results per kit

    Product Number:
    3215 SERELISA® ParaTB

    References:
    1. Data on file, Mycobacterium Paratuberculosis Antibody Test Kit – Product Improvement Validation Report Amendment, Zoetis Inc.
    2. White R, Marotti KR, Hines ME II, et al. Evaluation of a new enzyme-linked immunosorbent assay (ELISA) for Johne’s disease in goat serum. SOJ Vet Sci. 2016;2(1):1-6.
    3. Data on file. Study Report No. D8K0Z-US-15-001, Zoetis Inc.

DETECT. PREVENT. TREAT.

©2018 Zoetis Services LLC. All rights reserved. The product information provided in this site is intended only for residents of the United States. The products discussed herein may not have marketing authorization or may have different product labeling in different countries. The animal health information contained herein is provided for educational purposes only and is not intended to replace discussions with an animal healthcare professional. All decisions regarding the care of a veterinary patient must be made with an animal healthcare professional, considering the unique characteristics of the patient. DIA-00150