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SmartEIA Treponema pallidum IgM

SmartEIA Treponema pallidum IgM
EAN Code: 8595635306495
Catalog number: SK-TpM096
Package size: 96 tests
Regulatory status: IVD CE
Storage: 2-8 °C
Producer: TestLine Clinical Diagnostics s.r.o.
Delivery time: On request

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Contact person:

Name: MUDr. Jana Dočkalová
Phone: +420 549 121 205
E-mail: trade@testlinecd.com

The immunoenzymatic assay is intended for the diagnosis, monitoring and screening of Treponema pallidum infection using IgM antibodies in human serum or plasma in the general population. The semi-quantitative semi-automated assay is designed for professional use in a laboratory.

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Description

Description:

  • Microtitre wells are coated with the monoclonal antibody to human IgM.
  • Total IgM antibodies in the sample, including the specific anti-T.pallidum antibodies (if present), bind to the anti-human IgM antibodies in quantities proportionate to their presence.
  • Specific antibodies bound to the solid phase are subsequently labelled with the Conjugate (containing specific antigens of T. pallidum, particularly p47 and p17 conjugated with horseradish peroxidase) and detected through colour reaction with substrate (TMB-Complete).
  • The kit allows 96 tests, including controls in a split microtiter plate with color-coded strips and breakable wells.

Advantages:

  • The total assay time is about 2 hours 30 minutes.
  • High sensitivity and specificity of the test.
  • Kit includes CUT-OFF, Positive Control and Negative Control, Calibrators.
  • Semi-quantitative evaluation in the Index of Positivity (IP).
  • Ready-to-use, color-coded components.
  • Single-component substrate.
  • Interchangeable components with the exception of kit specific components (Controls, Conjugate, Plate).

Application:

  • Highly sensitive and specific ELISA method for detection of anti-treponema IgG is suitable for screening as well as confirmation of non-treponemal (VDRL, RPR, etc.) and treponemal (TPHA, etc.) test results.
  • Determination of IgG and IgM antibodies enables to distinguish between contemporary and previously undergone infection, diagnostics of congenital infection, monitoring of antibiotic treatment efficiency.

Brief assay procedure:

  1. Dilute samples (1:101).
  2. Pipette Controls and diluted Samples.
  3. Incubate at 37°C for 60 min.
  4. Aspirate and wash the wells 5×
  5. Pipette Conjugate.
  6. Incubate at 37°C for 30 min.
  7. Aspirate and wash the wells 5×
  8. Pipette Substrate (TMB-Complete).
  9. Incubate at 37°C for 30 min.
  10. Pipette Stop Solution.
  11. Read color intensity at 450 nm.
  12. Evaluate the test.

SmartEIA kits are specifically designed for automated processing on the Agility® instrument, Dynex Technologies, Inc.

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