Accu-Tell® Treponema Pallidum ELISA Test Kit
Product Description
CATALOG
| Product Name | Specimen | Catalog No. | Quantity per box |
| Treponema Pallidum(TP) Elisa Test | Serum/Plasma | ABT-EIA-F8 | 96 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 plate | one |
| 2. Negative Control | 1x0.5ml |
| 3. Positive Control | 1x0.5ml |
| 4. HRP-Conjugate | 1x14ml |
| 5. Wash Buffer | 1x50ml |
| 6. Chromogen Solution A | 1x8ml |
| 7. Chromogen Solution B | 1x8ml |
| 8. Stop Solution | 1x8ml |
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-Conjugate | 100ml |
| Add Samples / Controls | 20ml |
| Incubate | 60minutes |
| Wash | 5times |
| Coloring | 50ml A + 50ml B |
| Incubate | 15minutes |
| Stop the reaction | 50ml stop solution |
| Read the absorbance | 450nm 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 Center | TPPA Positive | TPPA Suspicious | TPPA Negative |
| Blood Bank 1 | 14/14 | - | 2888/2890 |
| Blood Bank 2 | 6/6 | - | 521/521 |
| Blood Bank 3 | 76/76 | 4/6 | 59/59 |
| Blood Bank 4 | 8/8 | 0/2 | 148/148 |
| Blood Bank 5 | 90/90 | 1/1 | 13/13 |
| Blood Bank 6 | 80/80 | - | 12/12 |
| Blood Bank 7 | 2/2 | 0/2 | 148/148 |
| Blood Bank 8 | 137/139 | 5/6 | 70/70 |
| Total | 413/415 | —— | 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.
| Samples | anti-TP ELISA | TRUST/PRP | TPPA/TPHA | ||||
| Syphilis | No. | + | - | + | - | + | - |
| 1stperiod | 66 | 60 | 6 | 55 | 11 | 59 | 7 |
| 2ndperiod | 140 | 140 | 0 | 131 | 9 | 138 | 2 |
| 3rd period | 2 | 2 | 0 | 2 | 0 | 2 | 0 |
| latent period | 14 | 14 | 0 | 13 | 1 | 14 | 0 |
| TOTAL | 222 | 216 | 6 | 201 | 21 | 213 | 9 |
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.
| Reproducibility | Within run | Between run | |||
| Specimen Type | N | Mean A/C.O. | CV | Mean 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.
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