BLASTOMYCES QUANTITATIVE EIA TEST

• Test Code

  316

• CPT Code

  87449

• 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

  It is possible that specimens positive for Candida tropicalis, Coccidioides immitis, Coccidioides posadasii, Histoplasma capsulatum, Histoplasma duboisii, Paracoccidioides brasiliensis, Talaromyces marneffei and Aspergillus nidulans may cross-react with the Blastomyces Antigen EIA and test positive.

  A variety of interfering substances, as follows, were investigated for each specimen type and none affected the Blastomyces Antigen EIA sensitivity or specificity.

   

  • Urine: glucose, protein, microalbumin, creatine, uric acid, BUN, bilirubin, nitrite, ketones, WBCs, blood/ hemoglobin, antihistamine, ascorbic acid, cough syrup, boric acid, ethyl paraben
  • Serum: protein, bilirubin, cholesterol, triglycerides, hemoglobin
  • CSF: protein, blood BAL: blood
  • Plasma: protein, bilirubin, cholesterol, triglycerides, hemoglobin, lithium heparin, sodium citrate
• 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.
• Minimum Specimen Requirements
  • Serum: 1.2 mL
  • Urine, BAL and other body fluid: 0.5 mL CSF: 0.8 mL
• Specimen Stability
  • Room Temperature: 14 days
  • Refrigerated: 14 days
  • Frozen: indefinite
• 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 to arrive Monday–Saturday using a next day delivery service. Samples may be shipped on dry ice, frozen ice packs, or ambient.

• Turnaround Time

  Testing is performed Monday-Saturday.

  • Urine/BAL: Same day
  • Serum/Plasma/CSF: 1 day

  *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.