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Acanthamoeba species Molecular Detection, PCR, Ocular
Test Code10349
CPT Codes
87798<br>Restricted Client Code
Preferred Specimen
10 mm fresh ocular tissue collected in a sterile container with 1 mL saline, minimal essential media (MEM), or viral transport media, or Formalin-fixed, paraffin-embedded ocular tissue block (FFPE) submitted in a tissue block container (T553)
Minimum Volume
5 mm biopsy • 0.5 mL eye, ocular, cornea, or swabs
Other Acceptable Specimens
5 (10-micron) sections from ocular formalin-fixed, paraffin-embedded tissue block, submitted in individual separate sterile container(s) • 1 mL Eye, ocular, or cornea scrapings, or swabs • Contact lenses, entire collection submitted in a sterile container with 1 mL sterile saline, contact solution, viral transport media, or minimum essential media (MEM) • 1 mL contact lens solution or entire lens case w/o lenses, submitted in a sterile container
Instructions
The preferred specimen for this test is corneal scraping or biopsy. Specimen source is required.
Submit only 1 of the following specimens:
(Preferred samples)
Specimen Type: Ocular Tissue, fresh
Submit tissue in a sterile container with 1 mL of sterile saline, minimal essential media (MEM), or viral transport media.
Specimen Type: Paraffin-embedded tissue block:
Submit a FFPE tissue block to be cut and returned.
(Acceptable samples)
Specimen Type: Formalin-fixed, Paraffin-embedded tissue block sections:
Container/Tube: Sterile container for each individual cut section (scroll). Instructions: Perform microtomy and prepare five separate 10-micron sections. Each section (scroll) must be placed in a separate sterile container for submission.
Specimen Type: Scrapings, swabs:
1. Collect corneal scrapings using a scalpel or other sharp device to remove the outer layer of cells from the eye.
2. Swish the collection device in 1 mL of sterile saline, minimal essential media (MEM), or viral transport media.
3. Remove the collection device from the collection container before submitting to the lab.
4. Specimens containing scalpel blades will be canceled.
Additional Information: Swabs are not the preferred specimen for this test and may yield false-negative results. Specimens collected using wooden shafted swabs and calcium alginate-tipped swabs will be canceled.
Specimen Type: Contact lenses, entire collection:
1. Place entire contact lens in a sterile container with 1 mL sterile saline, contact lens solution, viral transport media, or minimal essential media (MEM).
2. Right and Left lenses must be submitted individually using multiple sterile containers or in the original contact lens case. Multiple orders must be created.
3. Indicate Right or Left in the specimen source.
Specimen Type: Contact lens solution in case without lens:
Additional Information:
1. Depending on the type of case submitted, it may be necessary to test right and left chambers individually. Multiple orders must be created.
2. Indicate Right or Left in the specimen source.
Note: Although verification experiments did not detect Acanthamoeba species DNA in contact lenses from asymptomatic adults, it is possible that PCR may detect asymptomatic colonization/contamination and, therefore, testing should not be performed on asymptomatic individuals.
Submit only 1 of the following specimens:
(Preferred samples)
Specimen Type: Ocular Tissue, fresh
Submit tissue in a sterile container with 1 mL of sterile saline, minimal essential media (MEM), or viral transport media.
Specimen Type: Paraffin-embedded tissue block:
Submit a FFPE tissue block to be cut and returned.
(Acceptable samples)
Specimen Type: Formalin-fixed, Paraffin-embedded tissue block sections:
Container/Tube: Sterile container for each individual cut section (scroll). Instructions: Perform microtomy and prepare five separate 10-micron sections. Each section (scroll) must be placed in a separate sterile container for submission.
Specimen Type: Scrapings, swabs:
1. Collect corneal scrapings using a scalpel or other sharp device to remove the outer layer of cells from the eye.
2. Swish the collection device in 1 mL of sterile saline, minimal essential media (MEM), or viral transport media.
3. Remove the collection device from the collection container before submitting to the lab.
4. Specimens containing scalpel blades will be canceled.
Additional Information: Swabs are not the preferred specimen for this test and may yield false-negative results. Specimens collected using wooden shafted swabs and calcium alginate-tipped swabs will be canceled.
Specimen Type: Contact lenses, entire collection:
1. Place entire contact lens in a sterile container with 1 mL sterile saline, contact lens solution, viral transport media, or minimal essential media (MEM).
2. Right and Left lenses must be submitted individually using multiple sterile containers or in the original contact lens case. Multiple orders must be created.
3. Indicate Right or Left in the specimen source.
Specimen Type: Contact lens solution in case without lens:
Additional Information:
1. Depending on the type of case submitted, it may be necessary to test right and left chambers individually. Multiple orders must be created.
2. Indicate Right or Left in the specimen source.
Note: Although verification experiments did not detect Acanthamoeba species DNA in contact lenses from asymptomatic adults, it is possible that PCR may detect asymptomatic colonization/contamination and, therefore, testing should not be performed on asymptomatic individuals.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 7 days
Refrigerated: 7 days
Frozen: 7 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Calcium alginate-tipped swab • Wood swab • Transport swab containing gel • Specimens containing scalpel blades • Unstained slides
Methodology
Real-Time Polymerase Chain Reaction (PCR) • TaqMan DNA Probe Hybridization
FDA Status
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Setup Schedule
Set up: Mon-Sat; Report available: 2-3 days
Reference Range
Negative
Clinical Significance
Aids in the diagnosis of amebic keratitis conjunction with clinical findings
