Antigen Detection

HISTOPLASMA QUANTITATIVE EIA TEST

  • Test Code

    310

  • CPT Code

    87385

  • Clinical Significance

    Antigen detection complements serologic and mycologic tests for diagnosis of histoplasmosis. Antigen may be detected early in the course of infection, before the development of antibodies, and more quickly than traditional culture. Antigen detection tests offer faster results and are highly sensitive, especially in urine and blood samples of patients with dissemintated histoplasmosis and CSF and bronchoalveolar lavage liquid samples of patients with pulmonary histoplasmosis. These tests are also useful for monitoring treatment, as antigen levels typically decrease with effective therapy.

  • Methodology
    • Quantitative Sandwich Enzyme Immunoassay (EIA)
    • Serum and CSF are pre-treated to improve sensitivity
  • Limitations

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

    • Cross-reactions are seen with Blastomyces spp., Coccidioides spp., and Paracoccidioides brasiliensis. Less frequently in coccidioidomycosis, rarely in aspergillosis and possibly sporotrichosis.
    • Sputolysin, sodium hydroxide and potassium hydroxide treatment degrade the analyte detected in the assay.
  • Specimen Collection
    • Serum:  Collect serum specimens in serum separator or red top tube. Allow blood to clot for 30 minutes, then centrifuge. Pipette serum into a plastic screw cap vial.
    • Plasma: Collect plasma specimens in an EDTA, heparin or sodium citrate tube. Centrifuge for 15 minutes and pipette plasma into a plastic screw cap vial.
    • Urine/CSF/BAL/Other Body Fluid: Submit urine, CSF, BAL and all other body fluids in a sterile screw cap container.
    • New York approved for Urine, Serum, Plasma, CSF, and BAL samples.
  • Minimum Specimen Requirements
    • All specimen: 0.8 mL
  • Specimen Stability
    • Room Temperature: 2 weeks
    • Refrigerated: 2 weeks
    • Frozen: Indefinitely
  • Specimen Rejection
    • If specimen is too viscous to pipette
    • Tissue, Sputum, Bronchial Brushings, Stool, FNA, Biopsy, Tracheal or Bone Marrow Aspirate
    • Stored in Transport Media, Fixative or Isolator Tubes
  • Transport Temperature

    Refrigerated/Frozen/Room Temperature

  • Shipping

    Ship next day service for Monday-Saturday delivery. Samples may be shipped on dry ice, frozen ice packs, or ambient.

  • Turnaround Time

    Testing is performed Monday-Saturday.

    • All specimen: Same day

    *New positives may 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

    None detected

  • Interpretative Information
    • Positive: 0.20-20.00 ng/mL
    • Positive Above the Limit of Quantification: Results greater than 20.00 ng/mL fall outside the linear range of the assay. These results are positive, but not accurately quantifiable.
  • Additional Information

    MVista® is a registered trademark of MiraVista Diagnostics

* 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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