Diagnostic Kit For Anibody To Treponema Pallidum Colloidal Gold
Production information| Model Number | TP-AB | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic Kit For Anibody To Treponema Pallidum Colloidal Gold | Instrument classification | Class I |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Summary Syphilis is a chronic infectious disease caused by treponema pallidum, which is mainly spread through direct sexual contact. TP can be also passed to the next generation via the placenta, which leads to stillbirth, premature delivery, and infants with congenital syphilis.In normal infection, TP-IgM can be detected first, which disappears upon effective treatment. TP-IgG can be detected upon occurrence of IgM, which may exist for relatively long time. Detection of TP antibody is of great significance to prevention of TP transmission and treatment of TP antibody.Intend Use This kit is applicable to in vitro qualitative detection of antibody to treponema pallidum in human serum/plasma/whole blood sample, and it’s used for auxiliary diagnosis of treponema pallidum antibody infection. This kit only provides treponema pallidum antibody detection result, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
The WIZ BIOTECH reagent test will be compared with the control reagent: | Test result of wiz | Test result of reference reagents | Positive coincidence rate:99.03%(95%C.I.94.70%~99.83%) Negative coincidence rate: 99.34%(95%C.I.98.07%~99.77%) Total compliance rate: 99.28%(95%C.I.98.16%~99.72%) | ||
| Positive | Negative | Total | ||
| Positive | 102 | 3 | 105 | |
| Negative | 1 | 450 | 451 | |
| Total | 103 | 453 | 556 | |
Test procedure | 1 | Remove reagent from aluminum foil pouch, lie it on a flat bench, and do a good job in sample marking |
| 2 | In case of serum and plasma sample, add 2 drops to the well, and then add 2 drops of sample diluent dropwise. In case of whole blood sample, add 3 drops to the well, and then add 2 drops of sample diluent dropwise. |
| 3 | Result shall be interpreted within 15-20 minutes, and detection result is invalid after 20 minutes. |
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