Blastomyces Antigen EIA

• Test Information
• Specimen Requirements
• Shipping Information

• Test Code +

  316

  Clinical Significance +

  The MVista® Blastomyces Antigen Quantitative EIA can detect and quantify the amount of Blastomyces antigen in patient samples. It can be used to aid in the diagnosis of blastomycosis, to monitor the response to therapy and to determine when treatment can be modified or stopped. Monitoring of Blastomyces antigen levels also helps determine relapse of disease.

  During validation testing, the sensitivity was found to be 95.00% and specificity 100% with an assay cutoff of 0.31 ng/mL.

  Methodology +

  Quantitative Sandwich Enzyme Immunoassay (EIA)

  Limitations +

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

  Cross Reactivity/False Positive:

  • Very High: Histoplasma, Paracoccidioides and Talaromyces (talaromycosis, previously penicilliosis)
  • Moderate: Coccidioides
  • Rare: Aspergillus
  • None: Cryptococcus

  • Sputolysin, sodium hydroxide and potassium hydroxide treatment degrade the analyte detected in the assay.

  Turnaround Time +

  Testing is performed Monday – Saturday.

  • Results released: 8 – 24 hours

  *New positives may require confirmation

  Reference Range +

  Negative
  0.31 ng/mL – 20.00 ng/mL
  Results above 20.00 ng/mL are reported as ‘Positive, Above the Limit of Quantification’

   

  Interpretative Information +

  Negative: <0.31 ng/mL
  Positive: ≥0.31 ng/mL – 20.00 ng/mL

  Positive Above the Limit of Quantifications

  Results greater than 20.00 ng/mL fall outside the linear range of the assay. These results are positive, but not accurately quantifiable.
  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.

• Specimen Collection +

  Specimen: Urine, Serum, Plasma, CSF, BAL

  Anticoagulant: Heparin, EDTA, NaCit

  Container:
  Serum/Plasma: Submit serum and plasma in a separator or transfer tube.
  Urine/CSF/BAL/Other Body Fluids: Submit urine, CSF, BAL or any other body fluids in a leak-proof container.

  Minimum Specimen Requirements +

  Volume: 0.8 mL

  Specimen Stability +

  • Room Temperature: 14 days
  • Refrigerated: 14 days
  • Frozen: 60 days

  Specimen Rejection +

  • Received cold or room temperature >14 days old (requires suboptimal approval)
  • Non-pipettable specimens, tissue, biopsy, sputum, bronchial brush, tracheal aspirate, FNA, bone marrow, aspirate or stool
  • Samples in transport media, fixative or Isolator tubes

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

• Transport Temperature +

  Room Temperature/Refrigerated/Frozen

  Shipping +

  Ship Overnight or 2nd day ambient

* 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.