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Accu-Tell® Treponema Pallidum ELISA Test Kit

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Accu-Tell® Treponema Pallidum ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to Treponema Pallidum in human serum or plasma samples. It is intended to be used in clinical laboratories for diagnosis and management of patients related to infection with Treponema Pallidum.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per box
Treponema Pallidum(TP) Elisa TestSerum/PlasmaABT-EIA-F896 T


SUMMARY OF THE MAJOR COMPONENTS OF THE KIT:

Use this summary only as a reference and always follow the comprehensive method sheet when performing the assay. Note: the components of individual kits are not lot- interchangeable.

1. Microwell plateone
2. Negative Control1x0.5ml
3. Positive Control1x0.5ml
4. HRP-Conjugate1x14ml
5. Wash Buffer1x50ml
6. Chromogen Solution A1x8ml
7. Chromogen Solution B1x8ml
8. Stop Solution1x8ml


SUMMARY OF THE ASSAY PROCEDURE:

Use this summary only as a reference and always follow the detailed method sheet when performing the assay.

Add HPR-Conjugate100ml
Add Samples / Controls20ml
Incubate60minutes
Wash5times
Coloring50ml A + 50ml B
Incubate15minutes
Stop the reaction50ml stop solution
Read the absorbance450nm or 450/630 nm


INTENDED USE

ACCU-TELL® Treponema Pallidum ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to Treponema Pallidum in human serum or plasma samples. It is intended to be used in clinical laboratories for diagnosis and management of patients related to infection with Treponema Pallidum.

 

PERFORMANCE CHARACTERISTICS

The clinical performances of this assay have been evaluated by a panel of samples obtained from 4293 healthy blood donors from 8 blood banks. The sensitivity of ACCU-TELL® Treponema Pallidum ELISA Kit of blood donors were 99.52% (413/415), while the specificity were 99.95% (3859/3861).

Testing CenterTPPA PositiveTPPA SuspiciousTPPA Negative
Blood Bank 114/14-2888/2890
Blood Bank 26/6-521/521
Blood Bank 376/764/659/59
Blood Bank 48/80/2148/148
Blood Bank 590/901/113/13
Blood Bank 680/80-12/12
Blood Bank 72/20/2148/148
Blood Bank 8137/1395/670/70
Total413/415——3859/3861

The serum samples collected from 222 syphilitic patients who had been diagnosed correctly by clinic (including 1st period, 2nd period, 3rd period and latent period Syphilis), 42 autoimmune diseases patients excluding syphilis (RPR testing positive) and 270 healthy blood-donors, then they were tested for antibody against treponema pallidum by RPR, TPPA and TP-ELISA methods respectively. Results: The positive rates of TP-ELISA, TPPA and RPR for detection of antibody against treponema pailidum were 97.30% (216/222), 95.95% (213/222) and 90.54% (201/222) respectively. There was no statistical difference between TPPA and TP-ELISA for diagnose of syphilis (P>0.05). It didn’t appear false positive in TPPA and TP-ELISA methods to 42 autoimmune diseases patients excluding syphilis.

Samplesanti-TP ELISATRUST/PRPTPPA/TPHA
SyphilisNo.+-+-+-
1stperiod666065511597
2ndperiod140140013191382
3rd period2202020
latent period14140131140
TOTAL2222166201212139

Analytical Specificity:

No cross reactivity was observed with specimens from patients infected with HAV, HCV, HBV, HTLV, CMV, and HIV.

No interference was observed from rheumatoid factors up to 2000U/ml.

No high dose hook effect observed during clinical testing.

The assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.

ReproducibilityWithin runBetween run
Specimen TypeNMean A/C.O.CVMean A/C.O.CV

Weak positive

Moderate

positive

Strong positive

10

10

10

3.35

6.75

10.90

8.4%

7.0%

4.2%

3.23

6.40

10.30

9.0%

7.5%

4.4%


LIMITATIONS

1. Positive results must be confirmed with another available method and interpreted in conjunction with the patient clinical information.

2. Antibodies may be undetectable during the early stage of the disease and in some immunosuppressed individuals. Therefore, negative results obtained with ACCU-TELL® Treponema Pallidum ELISA Kit are only indication that the sample does not contain detectable level of anti-TP antibodies and any negative result should not be considered as conclusive evidence that the individual is not infected with TP.

3. If, after retesting of the initially reactive samples, the assay results are negative, these samples should be considered as non-repeatable (false positive) and interpreted as negative. As with many very sensitive ELISA assays, false positive results can occur due to the several reasons, most of which are related but not limited to inadequate washing step.

4. The most common assay mistakes are: using kits beyond the expiry date, bad washing procedures, contaminated reagents, incorrect assay procedure steps, insufficient aspiration during washing, failure to add specimens or reagents, improper operation with the laboratory equipment, timing errors, the use of highly hemolyzed specimens or specimens containing fibrin, incompletely clotted serum specimens.

5. The prevalence of the marker will affect the assay’s predictive values.

6. This assay cannot be utilized to test pooled (mixed) serum or plasma. ACCU-TELL® Treponema Pallidum ELISA Kit has been evaluated only with individual serum or plasma specimens.

7. ACCU-TELL® Treponema Pallidum ELISA Kit is a qualitative assay and the results cannot be used to measure antibodies concentrations.

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.