For the direct detection and identification of fungi in tissue.
Polymerase Chain Reaction/Sequencing
Sun, Mon, Wed
Transfer fresh tissue to a sterile container and freeze immediately. (Min: 25 mg) Also acceptable: Formalin-fixed paraffin-embedded (FFPE) tissue. (Min: 3 10-micron thick sections).
Fresh Tissue: Frozen. FFPE: Room temperature.
Finger nails, toe nails, or bone. Formalin-fixed paraffin-embedded tissue on slides.
Fresh Tissue: Ambient: 5 days; Refrigerated: 5 days; Frozen: 5 days
FFPE: Ambient: 1 month; Refrigerated: 1 month; Frozen: Unacceptable
This assay detects and identifies human fungal pathogens by Sanger sequencing. This assay cannot differentiate invasive fungal infection from environmental fungal DNA. Clinical correlation of sequencing result is recommended.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
|Component Test Code*||Component Chart Name||LOINC|
|3000497||PanFungal Identification by Sequencing|