Treponema Pallidum by IHC
Also known as: TPALL IHC
Use
The test applies immunohistochemical staining to detect Treponema pallidum in formalin‑fixed, paraffin‑embedded tissue samples. It is intended to support clinical diagnosis by visually identifying the presence of Treponema organisms in tissue specimens. The test performance characteristics were developed and determined by ARUP Laboratories in a CLIA‑certified laboratory, for clinical purposes only. It has not been cleared or approved by the U.S. Food and Drug Administration.
Special Instructions
This is a stain‑and‑return (technical) service only. The test is performed Monday through Friday. Refer to ARUP Immunohistochemistry Stain Offerings brochure for ordering recommendation. It is an Analyte Specific Reagent (ASR).
Limitations
The test has not been cleared or approved by the US Food and Drug Administration. It is limited to use as a stain‑and‑return technical service; results interpretation requires appropriate clinical correlation. It is validated on formalin‑fixed paraffin‑embedded tissue or cellblock preparations; nonrepresentative or depleted tissue specimens are unacceptable.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 77202-0
- 94736-6
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
(Min: 2 slides)
Container
Tissue block or 5 unstained positively charged slides
Collection Instructions
Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen (cells must be prepared into a cellblock). Protect from excessive heat. Transport tissue block and/or slides in a tissue transport kit (ARUP supply #47808). If sending precut slides, do not oven bake.
Storage Instructions
Room temperature or refrigerated; ship in cooled container during summer months.
Causes for Rejection
Non‑representative tissue type; depleted specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |
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