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.
* This volume does not allow for repeat testing
Allow blood to clot for 30 minutes
Centrifuge and separate serum from cells
If specimen is too viscous to pipette
Stored in Transport Media, Fixative or Isolator Tubes
Tissue, Sputum, Bronchial Brushings, Stool, FNA, Biopsy, Tracheal or Bone Marrow Aspirate
* This volume does not allow for repeat testing
Centrifuge specimen for 15 minutes and pipette into a plastic vial
Identify specimen as plasma on container
If specimen is too viscous to pipette
Stored in Transport Media, Fixative or Isolator Tubes
Tissue, Sputum, Bronchial Brushings, Stool, FNA, Biopsy, Tracheal or Bone Marrow Aspirate
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.
New positives may require confirmation
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.
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
1 to 2 Days
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