MVista® Blastomyces Quantitative Antigen EIA
BLASAG
Test Summary
N/A
Aliases
N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Minimum Volume
0.8 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Room temperature/Refrigerated/Frozen
Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 2 months
Limitations
It is possible that specimens positive for Candida tropicalis, Coccidioides immitis, Coccidioides posadasii, Histoplasma capsulatum, Histoplasma duboisii, Paracoccidioides brasiliensis, Talaromyces and Aspergillus nidulans may cross-react with the Blastomyces Antigen EIA and test positive. A variety of interfering substances, as follow, 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
CSF: protein, blood
BAL: blood
Other Acceptable Specimens
N/A
Unacceptable Specimens
Received cold or room temperature > 14 days old Non-pipettable specimens, tissue, biopsy, sputum, bronchial brush, tracheal aspirate, FNA, bone marrow, aspirate or stool. Samples in transport media, fixative or Isolator tubes.
Order Code
BLASAG
EPIC (Premier) Code
LAB103213
Includes
N/A
CPT Code
87449
Billing Code
671365
CPT Statement
Methodology
Quantitative Sandwich Enzyme Immunoassay (EIA)
FDA Status
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.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
4444 Decatur Blvd
Suite 300
Indianapolis IN, 46241
Department
Reference Range
Negative: 0.31 ng/mL - 20.00 ng/mL
Results about 20.00 ng/mL are reported as: "Positive, Above the Limit of Quantification"
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Reports Available: Urine/BAL: same day CSF: 1 day
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Minimum Volume
0.8 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Room temperature/Refrigerated/Frozen
Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 2 months
Limitations
It is possible that specimens positive for Candida tropicalis, Coccidioides immitis, Coccidioides posadasii, Histoplasma capsulatum, Histoplasma duboisii, Paracoccidioides brasiliensis, Talaromyces and Aspergillus nidulans may cross-react with the Blastomyces Antigen EIA and test positive. A variety of interfering substances, as follow, 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
CSF: protein, blood
BAL: blood
Other Acceptable Specimens
N/A
Unacceptable Specimens
Received cold or room temperature > 14 days old Non-pipettable specimens, tissue, biopsy, sputum, bronchial brush, tracheal aspirate, FNA, bone marrow, aspirate or stool. Samples in transport media, fixative or Isolator tubes.
Result Information
Methodology
Quantitative Sandwich Enzyme Immunoassay (EIA)
Testing Laboratory
Reference Range
Negative: 0.31 ng/mL - 20.00 ng/mL
Results about 20.00 ng/mL are reported as: "Positive, Above the Limit of Quantification"
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Reports Available: Urine/BAL: same day CSF: 1 day