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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.
*Treponema 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.
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 |
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Prozone |
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| Correlation between IMMUNOTICLES AUTO3 TP and Conventional 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-BM1650 (JEOL).
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