Uncut sheet for Antibody to Treponema Pallidum TP-AB Syphilis
1. INTEDED 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.
2. PRODUCT SPECIFICATION
| Model No. | TP-AB Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Whole blood /Serum/Plasma |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in 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 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
