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MVista® Blastomyces Antigen Quantitative EIA

Test Summary

This test is an allergen-specific IgE antibody test that quantifies an individual’s IgE response to beta-lactoglobulin. It is an in vitro quantitative assay, which is intended to be used in conjunction with other clinical information to aid in the diagnosis of food Used to detect possible allergic responses to various substances in the environment [1].

While allergen-specific serum IgE testing is considered comparable to skin testing in many instances, both the American Academy of Used to detect possible allergic responses to various substances in the environment, Asthma, and Immunology and the American College of Used to detect possible allergic responses to various substances in the environment, Asthma, and Immunology recognize that allergen-specific serum IgE testing may be preferred in some clinical situations. These include 1) the presence of widespread skin disease, 2) the recent use of antihistamines or other medications that can affect the results of Used to detect possible allergic responses to various substances in the environment skin tests, 3) uncooperative patients, and 4) medical history suggesting that allergen skin testing would pose a significant risk for a serious allergic reaction [1].

Food-specific IgE tests are extremely sensitive. However, a positive test result only indicates that a patient is IgE sensitized to the food of concern. Many IgE-sensitized patients do not develop any symptoms when this food is ingested. A diagnosis of food Used to detect possible allergic responses to various substances in the environment should only be made by a trained medical provider, after conducting a thorough clinical evaluation [2,3]. While food-specific IgE test results may contribute to that evaluation, they cannot replace it. In this regard, detection of food-specific IgE in serum provides evidence of IgE sensitization, but a history of clinical reactivity to the food of concern, is required to make a diagnosis of IgE-mediated food Used to detect possible allergic responses to various substances in the environment. Moreover, several forms of food hypersensitivity are not associated with the presence of food-specific IgE in serum.

More specific information about this allergen can be found at http://www.phadia.com/en/Products/Used to detect possible allergic responses to various substances in the environment-testing-products/ImmunoCAP-Allergen-Information/Food-of-Animal-Origin/Allergen-Components/nBos-d-5--lactoglobulin-Milk/

References
1. Bernstein IL, et al. Ann Used to detect possible allergic responses to various substances in the environment Asthma Immunol. 2008;100(suppl 3):S1-S148.
2. Sampson HA, et al. J Used to detect possible allergic responses to various substances in the environment Clin Immunol. 2014;134(5):1016-1025.
3. Boyce JA, et al. J Used to detect possible allergic responses to various substances in the environment Clin Immunol. 2010;126(6 suppl):S1-S58.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1 mL serum collected in SST tube

Minimum Volume

0.5 mL urine, BAL, other body fluids/serum 1.2 mL/CSF 0.8 mL

Instructions

Indicate specimen type and date drawn on test request form. Two unique patient identifiers required on specimen container.

Ship to arrive Monday-Friday using a next day delivery service or 2nd day service. Do not ship by first class mail. List all antifungal agents patient is receiving.

Note: Interfering substances and cross-reactivities include sodium hydroxide and sputolysin. Cross-reactivity occurs between blastomycosis and histoplasmosis and in paracoccidioidomycosis, penicillosis, coccidioidomycosis, aspergillosis and sporotrichosis.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 14 days
  • Refrigerated: 14 days
  • Frozen: Indefinitely

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.

Other Acceptable Specimens

Urine (2 mL) submitted in a sterile, leak - proof container • CSF or bronchoalveolar lavage or body fluids submitted in a sterile, leak-proof container • Plasma collected in: EDTA (lavender-top), or 3.2% sodium citrate (light blue-top), or sodium heparin (green-top) tube

Unacceptable Specimens

Samples in transport media • Fixative or isolator tubes • Tissue • biopsy • Sputum, tracheal aspirate • FNA • Bone marrow aspirate • Bronchial brush • Stool

Order Code

BLASTO

EPIC (Premier) Code

LAB3213

Includes

N/A

CPT Code

  • 87449

Billing Code

  • 671171

CPT Statement

Methodology

Enzyme Immunoassay (EIA)

FDA Status

This test was developed and its 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.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

MiraVista Laboratories
4444 Decatur Blvd
Suite 300
Indianapolis IN, 46241

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 1 day

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1 mL serum collected in SST tube

Minimum Volume

0.5 mL urine, BAL, other body fluids/serum 1.2 mL/CSF 0.8 mL

Instructions

Indicate specimen type and date drawn on test request form. Two unique patient identifiers required on specimen container.

Ship to arrive Monday-Friday using a next day delivery service or 2nd day service. Do not ship by first class mail. List all antifungal agents patient is receiving.

Note: Interfering substances and cross-reactivities include sodium hydroxide and sputolysin. Cross-reactivity occurs between blastomycosis and histoplasmosis and in paracoccidioidomycosis, penicillosis, coccidioidomycosis, aspergillosis and sporotrichosis.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 14 days
  • Refrigerated: 14 days
  • Frozen: Indefinitely

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.

Other Acceptable Specimens

Urine (2 mL) submitted in a sterile, leak - proof container • CSF or bronchoalveolar lavage or body fluids submitted in a sterile, leak-proof container • Plasma collected in: EDTA (lavender-top), or 3.2% sodium citrate (light blue-top), or sodium heparin (green-top) tube

Unacceptable Specimens

Samples in transport media • Fixative or isolator tubes • Tissue • biopsy • Sputum, tracheal aspirate • FNA • Bone marrow aspirate • Bronchial brush • Stool

Billing

CPT Code

  • 87449

Billing Code

  • 671171

CPT Statement

Result Information

Methodology

Enzyme Immunoassay (EIA)

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 1 day