PRODUCTS・SUPPORT

Features

  • High sensitivity measurement of nontreponemal 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. (Mixing required for R2 when first opened)
  • Use on various automated analyzers

Measurement Principle

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

*Cardiolipin, Lecithin, Cholesterol

Assessment of results

(1) Reference Cut-off Line

Results of 1.0U 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 RPR, clinical symptoms and other relevant tests. Positive measurement result of 1.0U or more with this reagent does not dismiss the possibility of false positive such as BFP(Biological False Positive). To confirm 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 1 fold by RPR card test (quantitative test) corresponds to the measurement result of 1.0U with IMMUNOTICLES AUTO3 RPR.
  • When WHO International Standard is measured, the result holds a relation of 1.0U=1.0IU.

Measured value

Reproducibility

N Mean SD CV Max. Min. Range
Sample 1 20 1.20 0.067 5.60% 1.3 1.1 0.2
Sample 2 20 2.84 0.079 2.79% 3.0 2.7 0.3

Linearity

Linearity

Prozone

Prozone

Correlation between IMMUNOTICLES AUTO3 RPR and Another Reagent

Correlation between IMMUNOTICLES AUTO3 RPR and Another 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).