Uncut sheet for Antibody to Treponema Pallidum TP-AB Syphilis
1. INTEDED USE
The Syphilis Antibody (TP-Ab) Rapid Test Device (the “Uncut sheet” format for manufacturing use) is intended for the qualitative detection of total antibodies (IgG, IgM, and IgA) to Treponema pallidum, the causative agent of syphilis, in human serum, plasma, or whole blood specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the screening and diagnosis of syphilis infection in patients with clinical signs and symptoms suggestive of syphilis, or for screening individuals at risk of T. pallidum exposure.
The device detects treponemal antibodies, which appear early after infection and persist for life, making this test useful for screening both early and late-stage syphilis . However, as a treponemal antibody test, it cannot distinguish between active and past/treated infection.
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
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 |
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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
6.EXHIBITION
