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Toxoplasma gondii Quantitative Real-time PCR

Test Code: 2200

Cpt Code:

87799 (x1)

Clinical Utility

Toxoplasma gondii is highly problematic when primary infection occurs during the first trimester of pregnancy, often leading to fetal death or when reactivation occurs in immunocompromised patients, leading to life-threatening disease including encephalitis and extracerebral toxoplasmosis. Onset of disease in most patients is preceded by an increase in parasite load. Monitoring blood levels of Toxoplasma gondii DNA correlates well with treatment.

Procedure

Extraction of Toxoplasma gondii DNA from specimen followed by amplification and detection using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

The primers and probes used in this assay are specific for known Toxoplasma gondii strains based on similarity search algorithms. Additionally, no cross reactivity was detected with any viral or protozoa pathogens.

Causes For Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling, specimens received in trap containers or specimen types other than those listed.

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

2207 amniotic fluid

NY approved. Assay Range: 266 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2245 aqueous fluid

NY approved. Assay Range: 1,423 copies/mL to 1x108 copies/mL. Transfer collected amount to sterile, screw top tube for shipment (minimum volume 0.05 mL). Do not add water, saline or other fluid media to container. Do not ship specimen in syringe. Store frozen and ship on dry ice to Viracor-IBT.

 

2209 BAL

NY approved. Assay Range: 212 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2226 bronch wash

NY approved. Assay Range: 212 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2203 CSF

NY approved. Assay Range: 183 copies/mL to 1x108 copies/mL.2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Store frozen and ship on dry ice for overnight delivery to Viracor-IBT.

2212 pericardial fluid

NY aprpoved. Assay Range: 266 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2211 pleural fluid

NY approved. Assay Range: 266 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2219 trach asp

NY approved. Assay Range: 212 copies/mL to 1x108 copies/mL.  2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2248 trach wash

NY approved. Assay Range: 212 copies/mL to 1x108 copies/mL.  2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

2214 vitreous fluid

NY approved. Assay Range: 1,423 copies/mL to 1x108 copies/mL. Transfer collected amount to sterile, screw top tube for shipment (minimum volume 0.05 mL). Do not add water, saline or other fluid media to container. Do not ship specimen in syringe. Store frozen and ship on dry ice to Viracor-IBT.

2216 whole blood

NY approved. Assay Range: 376 copies/mL to 1x108 copies/mL. 4-5 mL collected in EDTA (lavender top) tube (minimum volume 0.5 mL). Specimen must be received within 96 hrs of collection.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.

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