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Toxoplasma (Toxo) IgM EIA

Test Code: 30828

A special account is required to order pre-transplant testing. Contact Client Services or your account executive to set up a pre-transplant account to order this assay. Specimens should not be collected until after account has been created.

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Clinical Utility

The Platelia™ Toxo IgM kit is an in vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasma gondii in human serum or plasma (EDTA, Heparin, Citrate).

About Toxoplasmosis

Toxoplasmosis, caused by the parasite Toxoplasma gondii (T. gondii), has been implicated in serious congenital abnormalities following maternal infections just prior to or during pregnancy. Usually a mild or even asymptomatic disease in adults, toxoplasmosis acquired in utero has resulted in blindness, encephalomyelitis, impaired brain functions, convulsions, and death to infected neonates. Also, predisposition to server toxoplasmosis infection is common in persons known to have Acquired Immune Deficiency Syndrome (AIDS), or who are otherwise immunocompromised.

Toxoplasmosis can be treated with antibiotics but early detection of the disease is crucial to effective therapy. Complete eradication of the parasite becomes difficult after long-term, chronic infection. Specific diagnosis of T. gondii infection can be complicated and isolation of the parasite is rare. Serologic confirmation of T. gondii antibody is indicative of exposure to the parasite and has become widely accepted as a means to determine immune status and susceptibility to infection. T. gondii IgM antibody testing can be used to verify early infections caused by T. gondii in conjunction with conventional diagnostic procedures.

Diagnostic serology for Toxoplasmosis has professed from the use of a specialized dye test to immunofluorescence and enzyme immunoassay (EIA) determination of IgM antibodies to T. gondii. The kit includes two levels of control sera positive for T. gondii IgM antibody and a negative control serum. The test utilized a monoclonal antibody to T. gondii conjugated with peroxidase for enzymatic assay signal development.

Procedure

The Platelia Toxo IgM assay utilizes an immunoenzymatic double sandwich method. Diluted samples and controls are placed into microplate wells coated with antibodies to human IgM. The IgM antibodies present in the samples are captured by the solid phase. Remaining antibodies (including any of the IgG class) and other serum proteins are removed by washing. A solution containing T. gondii antigen and conjugate (monoclonal antibody to T. gondii labeled with horseradish peroxidase) is placed into each well. T. gondii IgM antibodies in the sample that are captured on the solid phase bind the T. gondii antigen-conjugate complex. Excess T. gondii antigen and conjugate are removed by washing. A chromogen solution is added which reacts with the conjugate to initiate a color development reaction. This reaction is stopped by the addition of an acid. The optical density readings for the samples are obtained with a spectrophotometer set at a wavelength of 450 nm. The presence of T. gondii IgM antibodies in an individual sample is determined by comparing the optical density reading for the sample to the optical density reading of the calibrator serum. Test performed by VRL Eurofins,  6933 S. Revere Parkway, Centennial, CO 80112. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information

Within 24 hours from receipt of specimen (Monday - Friday).

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
Serum 30828 86778 Yes

100 µL (min 50 µL)

Qualitative

  • Collect whole blood in an gold, red, or red/gray tiger top tube. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped at refrigerated temperature, must be received within 5 days.
  • If not shipping in original container, centrifuge and transfer 100 µL (min 50 µL) serum to screw top tube. Specimens shipped at refrigerated temperature must be received within 5 days of collection, or frozen.
Shipping

All specimens must be labeled with patient's name and collection date. A Viracor/VRL Eurofins Pre-Transplant test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: VRL Eurofins, 6933 S. Revere Parkway, Centennial, CO 80112.

Causes for Rejection

Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on VRL Eurofins' 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. VRL Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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