Test Code Lab6081 Toxoplasma Antibodies, IgG and IgM, Serum
Additional Codes
LAB6081
Methodology
Multiplex Flow Immunoassay, Bio-Rad Bioplex 2200
Testing Algorithm:
If Toxoplasma IgM is positive, confirmation will be performed, at an additional charge.
Literature References:
1. Package insert: Bio-Rad Bioplex 2200 System ToRC IgG IFU. 04-2019
2. Package insert: Bio-Rad BioPlex 2200 System TRC IgM IFU. 08-2017
Performing Laboratory
Barnes-Jewish Hospital Laboratory
Specimen Requirements
Specimen Type: Serum
Container/Tube: Plain red top, Red/Grey SST or Gold SST
Specimen Volume: Full tube
Specimen Transport Temperature
Ambient
Reference Values
Reference Value
Toxoplasma, IgG - Negative
Toxoplasma, IgM - Negative
Literature References:
1. Package insert: Bio-Rad Bioplex 2200 System ToRC IgG IFU.04-2019
2. Package insert: Bio-Rad BioPlex 2200 System TRC IgM IFU.08-2017
3. Clinical Laboratory Standards Institute(CLSI). Clinical Use and Interpretation of Serologic Testing for Toxoplasma gondii, Approved guideline. (M36-A), Feb 2004
Day(s) Test Set Up
Monday through Sunday, 0700 - 1300
Turnaround Time:
STAT: not available
Routine: results available the day of testing.
Test Classification and CPT Coding
86777-Toxoplasma IgG
86778-Toxoplasma IgM
86778-Toxoplasma IgM confirmation (if appropriate)
Additional Information
For BJH Laboratory Use Only
Analyte Stability:
Specimen stored at room temperature(18-30° C) for 3 days and store specimen at 2-8° C up to 7 days. Freeze specimen, devoid of RBCs, at ≤-20° C for longer storage. Do not store in frost-free freezers. Specimens tested after 3 freeze/thaw cycles showed no qualitative differences. Mix thoroughly after each thawing.
Avoid hemolysis.
Laboratory Processing Instructions:
Test performed in BJH Core Lab. Centrifuge, separate serum, and refrigerate at 4° C for 7 days.
LOINC Code Information
Name | LOINC Code |
Toxoplasma Antibody, IgG | 5390-0 |
Toxoplasma Antibody, IgM | 5335-5 |
Interpretive Data
Toxoplasma, igG
Negative- No detectable antibody.
Equivocal - Presence of detectable antibody cannot be determined.
Positive - Detectable levels of antibody present.
Toxoplasma, IgM
A positive result for Toxoplasma IgM must be interpreted cautiously, and in the context of clinical findings. Due to a high rate of false positive results with this assay, Clinical Laboratory Standards Institute (CLSI) guidelines recommend confirmatory testing with a different assay at a reference laboratory ( Clinical Laboratory Standards Institute(CLSI). Clinical Use and Interpretation of Serologic Testing for Toxoplasma gondii, Approved guideline. (M36-A), Feb 2004). Therefore, all initial positive results for Toxoplasma-specific IgM will be sent to Palo Alto Toxoplasma Serology Laboratory for confirmatory Toxoplasma-specific IgM testing. Results will be reported separately in a scanned report
Notes:
1. In patients infected with Toxoplasma gondii, the IgM antibody appears immediately before, or soon after, the onset of symptoms.
2. The U.S. Food and Drug Administration has advised that no one commercial Toxoplasma IgM test should be used to determine acute infection. If Toxoplasma IgM is positive, confirmation will be performed, at an additional charge.
3. Levels of IgG antibody to Toxoplasma gondii begin to rise 1 to 2 weeks after infection. Peak levels are reached in 6 to 8 weeks, then gradually decline over months to years. Low titers are generally detectable for life. The antibody titer does not correlate with severity of illness.