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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.
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 |
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Prozone |
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| Correlation between IMMUNOTICLES AUTO3 RPR and Another Reagent |
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Correlation between Serum and Plasma Samples |
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Effect of Interfering Substances
| Bilirubin-F/C |
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Hemolysate |
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| Lipemia |
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Heparin |
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| Sodium Citrate |
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EDTA Disodium Salt |
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* Data obtained with JCA-BM6050 (JEOL).
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