Antigen Detection

ASPERGILLUS EIA GALACTOMANNAN TEST

  • Test Code

    309

  • CPT Code

    87305

  • Clinical Significance

    Various chronic Aspergillus pathologies may be found in immunocompetent subjects, and their diagnosis often proves difficult. A process of mold sensitization is at the root of allergic manifestations such as asthma, allergic broncho-pulmonary aspergillosis (ABPA), which represents the most exacerbated clinical form. Aspergilloma represents the most typical non-allergic chronic pathology that is the result of colonization of a preexistent pulmonary cavity by fungal mycelia forming an Aspergillus ball. The PlateliaTM Aspergillus IgG assay, used to detect class G immunoglobulins directed against a recombinant purified antigen of Aspergillus, represents a tool for diagnostic assistance of these chronic forms of aspergillosis that are observed in immunocompetent subjects.

  • Methodology
    • Platelia™ Aspergillus EIA immunoenzymatic sandwich microplate assay, cleared by the FDA for the detection of galactomannan in serum or BALF.
    • Test validated at MiraVista Diagnostics for CSF specimens.
  • Limitations

    The result is not intended to be used as the sole means for clinical diagnosis or patient management decisions.

    False positives can be caused by:

    • Piperacillin-tazobactam, amoxicillin/clavulanic acid
    • PLASMA-LYTE and other fluids containing sodium gluconate. Patients must be off PLASMA-LYTE for at least 3 days before collection.
    • Infection with Penicillium, Alternaria, Paecilomyces, Fusarium Geotrichum, Histoplasma, and Blastomyces, or airway colonization with above organisms

    *Antifungal therapy may cause false negative results in patients with aspergillosis
    *Cross-reactions in CSF can occur with Histoplasma spp., Blastomyces spp., Cryptococcus neoformans, and Pseudomonas aeruginosa.

  • Specimen Collection
    • Serum: Separated from clot in a leak-proof container.
    • EDTA plasma: Separated from clot in a leak-proof container. (Reported with rare specimen comment applied.)
    • CSF/BAL: Submit CSF and BAL in a sterile leak-proof container.
    • New York approved for Serum, BAL, and CSF samples.
  • Minimum Specimen Requirements

    Serum/EDTA Plasma/CSF/BAL: 0.8 mL

  • Specimen Stability

    CSF:

    • Room Temperature: 30 days
    • Refrigerated: 30 days
    • Frozen: 60 days

    Serum/BAL/EDTA Plasma:

    • Room Temperature: 48 hours
    • Refrigerated: 5 days
    • Frozen: 5 months
  • Specimen Rejection
    • If specimen is too viscous to pipette.
    • Nasal washings, plasma from any tube other than EDTA.
    • Samples in fixative, transport media or PLASMA-LYTE.
  • Transport Temperature

    Refrigerated/ Frozen

  • Shipping

    Ship on dry ice for next day service. Frozen ice packs may be substituted if sample is shipped the day of the collection. Monday – Friday delivery.

  • Turnaround Time

    Serum/EDTA Plasma/CSF/BAL: Same Day

    *New positives my require confirmation

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

  • Reference Range

    Negative

  • Interpretative Information

    Negative: <0.5

    Results are reported as numeric values (Index) which are interpreted as positive or negative

  • Additional Information

    Platelia™ is a registered trademark of BioRad

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