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Antibody Detection

COCCIDIOIDES ANTIBODY IgG IgM EIA

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  • Test Code

    325

  • CPT Code

    86635 x2

  • Clinical Significance

    IgM and IgG antibodies to Coccidioides antigen usually appear during the first month of infection and decline over the next 3-6 months but remain detectable for approximately 18-24 months in some cases with self-limited illnesses. Antibodies may persist in patients with chronic pulmonary complications or progressive extrapulmonary (disseminated) coccidioidomycosis. Antibodies may be falsely negative in some progressive or chronic cases. Follow-up testing may be considered at weeks 2-4 to determine if antibody levels are increasing, especially in patients with low positive results. An increase in antibody concentration would suggest recent infection. Antibodies may also be detected in healthy subjects who are asymptomatic as a result of sub-clinical infection within the last 18-36 months. This test offers an improvement in sensitivity over the current methods of detecting antibodies by immuno diffusion and complement fixation.

  • Methodology

    Semi-Quantitative Indirect Enzyme Immunoassay (EIA)

  • Limitations

    Specimens positive for Aspergillus spp., Histoplasma capsulatum, Paracoccidioides brasiliensis, or Talaromyces marneffei may cross-react with the Coccidioides Antibody EIA (IgG and IgM detection) and test positive.

    A variety of interfering substances were investigated (hemoglobin/blood, total cholesterol, triglycerides, glucose, bilirubin, total protein, fluconazole, itraconazole, amphotericin B, voriconazole, vancomycin, piperacillin, tazobactam, ceftriaxone, tobramycin) and none affected the Coccidioides Antibody EIA sensitivity or specificity.

  • Specimen Collection
    • Serum/Plasma: Serum/Plasma separated from the clot in a leak-proof container.
    • CSF: Sterile leak-proof container.
    • New York approved for Serum samples.
  • Minimum Specimen Requirements

    Serum/Plasma*/CSF*: 0.25 mL

    *Reported with rare specimen comment applied.

  • Specimen Stability
    • Room Temperature: 30 days
    • Refrigerated: 30 days
    • Frozen: 30 days
  • Specimen Rejection

    >30 days old

    Two unique patient identifiers are required on the specimen container.

    Any specimen type other than serum, plasma, or cerebrospinal fluid (CSF)

    For specimen submissions that do not meet these criteria, please call Customer Service.

  • Transport Temperature

    Ambient/Refrigerated/Frozen

  • Shipping

    Ship to arrive Monday‐Friday using a next day delivery service. Samples may be shipped on dry ice, frozen ice packs, or ambient.

  • Turnaround Time

    Testing is performed Monday through Friday and reported the by the next day

  • Reference Range

    Negative

  • Interpretative Information

    Negative: <1.0 EU

    Positive: ≥1.0 EU

    CSF will be run with a non-validated disclaimer.

    Results should be correlated with clinical presentation and history.

  • Additional Information

    This test was developed, and its analytical performance characteristics determined by MiraVista Diagnostics. It has not been cleared or approved by the FDA; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

* New positives may require confirmation.

** Turnaround times are provided as ranges, and may vary depending on daily testing volumes and specimen type.

*** Test set up: Samples received by 10:30AM will have same-day test set up. Positive samples may require confirmation which may extend turnaround time. Serum & CSF specimens are pretreated to improve sensitivity which can add one day to turnaround time.

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