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Features

  • High sensitivity measurement of Treponemal antibody in serum and plasma
  • Enables rapid syphilis testing with plasma sample. Also suitable for non-office hour and emergency testing
  • Provides quantitative test results by automated testing for objective diagnosis
  • Mixing unnecessary - Set up reagents and use without mixing
  • Use on various automated analyzers

Measurement Principle

IMMUNOTICLES AUTO3 TP is based on an optical absorbance method using Latex agglutination method.
Polystyrene-latex with TP(Treponemal) antigen* on the surface and TP antibody in serum form agglutination clump by antigen-antibody reaction. Based on the principle that photometric change by this agglutination reaction relies on TP antibody value, this reagent measures TP antibody value in samples from the calibration curve drawn using TP antibody calibrator.

*Treponemal Pallidum, Nichols strain

Absorption test

In order to confirm that the positive results obtained using this reagent is not a result of a non-specific reaction, Neutralization Reagent (sold separately) for IMMUNOTICLES AUTO3 TP is provided. With the presence of TP antibody in serum or plasma, a specific reaction occurs between TP antibody and TP antigen in the Neutralization Reagent when it is added. As a result, TP antibody titer is lower considerably in comparison to the value before absorption.

Assessment of results

(1) Reference Cut-off Value

Results of 10U or more is assessed as positive.

(2) Precautions in Determination

Diagnosis of syphilis is ultimately made by a physician comprehensively combining results from IMMUNOTICLES AUTO3 TP, clinical symptoms and other relevant tests. Positive measurement result of 10U or more with this reagent does not dismiss the possibility of false positive. To confirm such positive findings, reference examination by another method based on different principles such as FTA-ABS method should be performed.

Measurement unit

  • QC pooled serum with the result of 1280 fold by TPHA quantitative test corresponds to the measurement result of 1280U with IMMUNOTICLES AUTO3 TP.
  • When WHO International Standard is measured, the result holds a relation of 1.0U=2.15mlU.

Measured value

Reproducibility

N Mean SD CV Max. Min. Range
Sample 1 20 9.82 0.263 2.68% 10.4 9.3 1.1
Sample 2 20 20.57 0.253 1.23% 21.1 20.0 1.1
Sample 3 20 88.33 0.855 0.97% 90.6 86.7 3.9

Linearity

Linearity

Prozone

Prozone

Correlation between IMMUNOTICLES AUTO3 TP and Conventional Reagent

Correlation between IMMUNOTICLES AUTO3 TP and Conventional Reagent

Correlation between Serum and Plasma Samples

Correlation between Serum and Plasma Samples

Effect of Interfering Substances

Bilirubin-F/C

Bilirubin-F/C

Hemolysate

Hemolysate

Lipemia

Lipemia

Heparin

Heparin

Sodium Citrate

Sodium Citrate

EDTA Disodium Salt

EDTA Disodium Salt

* Data obtained with JCA-BM1650 (JEOL).