MVista® 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.
  
  During validation testing, the combined sensitivity was found to be 92.00% and specificity 94.00% with an assay cutoff of 1.0 EU. It offers an improvement over the current method of detecting antibodies by FID, where sensitivity has been reported as only 32%. Complement fixation is even less sensitive than FID.

• 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: Collect serum specimens into a serum separator or red top tube. Allow blood to clot for 30 minutes, then centrifuge. Pipette serum separated from clot into a sterile, leak-proof container.

  CSF: Sterile transport tube

• Minimum Specimen Requirements

  Serum/CSF: 0.5 mL

• 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 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.