Toxoplasma gondii DNA, Qualitative Real-Time PCR

Test Code

34451

CPT Codes
87798

Preferred Specimen

1 mL amniotic fluid, CSF, or tissue collected in a sterile, leak-proof container, or
3 mm cubic mm tissue

Minimum Volume

3 cubic mm tissue • 0.2 mL vitreous fluid • 0.3 mL all other sample types

Other Acceptable Specimens

Serum • Whole blood or plasma collected in: EDTA (lavender-top) or ACD (yellow-top) tube • Amniotic fluid supernatant collected in: Sterile leak-proof container • 0.2 mL vitreous fluid collected in a sterile leak-proof container

Instructions

Raw vitreous fluid specimens: Do not dilute collected specimen with additional saline.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Whole blood
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: Unacceptable

All other specimens
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Hemolyzed whole blood

Methodology
Real-Time Polymerase Chain Reaction

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 1-2 days

Reference Range

Not Detected

Clinical Significance

Toxoplasma gondii, an obligate intracellular parasite, is an important opportunistic pathogen of immunosuppressed patients. In AIDS patients and transplant patients, this infection may result in a life-threatening encephalitis. T. gondii can also cause a fatal infection of the fetus if an infection is acquired during pregnancy. Fetal death or major abnormalities such as blindness and mental retardation may occur when infection is acquired during the first trimester. PCR methods may be useful in identifying T. gondii in CSF of immunosuppressed patients or in the amniotic fluid of mothers thought to be recently infected.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.