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BLOT-LINE Treponema IgM
Infectious Serology · Treponema pallidum Blot
TestLine Distributed by Goffin Diagnostics

BLOT-LINE Treponema IgM

The immunoblot assay is intended for the diagnosis of Treponema pallidum infection using IgM antibodies in human serum or plasma in the general population. The qualitative and semi-quantitative manual assay is designed for professional use in a laboratory.

Immunoblot CE-IVD TestLine 1 Package (20 Tests)
Technique
Immunoblot
Brand
TestLine
Packaging
1 Package (20 Tests)
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Product details

This kit in detail

Description

  • Antigen used: combination of selected parts of the high specific antigens TpN47, TpN17 (main membrane proteins) and specific antigens p41 and TpN15.
  • Recombinant antigens are transferred to the nitrocellulose membrane (i.e. to the respective BLOT ‐ LINE (BL) strips).
  • If specific antibodies are present in the sample, they will bind to the respective antigens.
  • The complex is labelled with Conjugate and detected through a colour reaction with substrate (BCIP/NBT).
  • The kit enables 20 tests.
  • Short incubation periods, total assay time: approximately 1.5 h.
  • High sensitivity and specificity.
  • All reagents supplied are ready to use.
  • The kit may be used sequentially for smaller batches of samples (reagents are provided in sufficient quantities).
  • Positive and Negative controls included enabling validation of the tests.
  • BL strips equipped with conjugate control band and a control band indicating kits functionality and sensitivity.
  • Colour identification in compliance with antibody classes.
  • Identical (i.e. interchangeable) reagents (except for Conjugate) in all BLOT-LINE kits.
  • Evaluation of results – the intensity of the bands can be evaluated visually or by means of software (Immunoblot Software).

Application

  • Laboratory test for the detection of infection with T. pallidum, confirmation of non-treponemal (VDRL, RPR, etc.) and treponemal (TPHA, ELISA, etc.) test results.
  • Confirmation of positive and questionable results.

Brief assay procedure

  1. Dilute serum/plasma samples (1:51).
  2. Pipette diluted samples and controls into the channels of the tray and insert the BL strips.
  3. Incubate for 30 min at room temperature using a shaking apparatus.
  4. Wash 3 times for 5 min.
  5. Add Conjugate.
  6. Incubate for 30 min at room temperature using a shaking apparatus.
  7. Wash 3 times for 5 min.
  8. Add substrate (BCIP/NBT).
  9. Incubate for 15 min at room temperature using a shaking apparatus.
  10. Wash 2 times for 5 min in distilled water.
  11. Dry the strips and evaluate results using the validation strip enclosed or using Immunoblot Software.

Specifications

  • EAN Code: 8595635301131
  • Catalog number: TpML20
  • Package size: 20 tests
  • Regulatory status: IVD CE
  • Storage: 2-8 °C
  • Producer: TestLine Clinical Diagnostics s.r.o.
Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

PDF LEAFLET_Treponema_ENPDF · download PDF LEAFLET_IMMUNOBLOT_full version_ENPDF · download
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