BLASTOMYCES QUANTITATIVE EIA TEST

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87449

Antigen detection complements serologic and mycologic tests for diagnosis of blastomycosis. 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 samples. These tests are also useful for monitoring treatment, as antigen levels typically decrease with effective therapy.

Quantitative Sandwich Enzyme Immunoassay (EIA)

When tested in cultures of 10⁵ – 10⁶ organisms/mL, cross-reactions occurred with Histoplasma spp., Coccidioides spp., Paracoccidioides brasiliensis, Talaromyces marneffei, Aspergillus nidulans, and Candida tropicalis.

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

• Serum/Plasma: Separated from the clot, in a leak-proof container.
• Urine/CSF/BAL/Other Body Fluid: Submit urine, CSF, BAL and all other body fluids in a sterile leak-proof container.
• New York approved for Urine, Serum, EDTA Plasma, CSF, and BAL samples.

• All specimen: 0.8 mL

• Room Temperature: 14 days
• Refrigerated: 14 days
• Frozen: 2 months

• 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.

Room Temperature/Refrigerated/Frozen

Ship to arrive Monday–Saturday using a next day delivery service. Samples may be shipped on dry ice, frozen ice packs, or ambient.

Testing is performed Monday-Saturday.

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

Negative

0.31 ng/mL – 20.00 ng/mL

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

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.

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.