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HelpEPIC ORDER CODE LAB1311 Aspergillus (Galactomannan) Antigen, Serum
Additional Codes
SQ: ASPAGM
Reporting Name
Aspergillus Ag, SUseful For
Aiding in the diagnosis of invasive aspergillosis
Assessing response to therapy
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Serum SSTOrdering Guidance
For bronchoalveolar lavage specimens, order ASPBA / Aspergillus Antigen, Bronchoalveolar Lavage.
Specimen Required
Container/Tube: Serum gel (red-top tubes are not acceptable)
Specimen Volume: 1.5 mL
Collection Instructions:
1. Avoid exposure of specimen to atmosphere to prevent sample contamination from environment.
2. Centrifuge and send specimen in original tube. Do not aliquot or open tube.
Specimen Minimum Volume
1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Refrigerated (preferred) | 14 days | SERUM GEL TUBE |
| Frozen | 14 days | SERUM GEL TUBE |
Reference Values
<0.5 index
Reference values apply to all ages.
Day(s) Performed
Monday through Friday, Sunday
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
87305
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ASPAG | Aspergillus Ag, S | 44357-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 84356 | Aspergillus Ag, S | 44357-2 |
Clinical Information
Invasive aspergillosis (IA) is a severe infection that occurs in patients with prolonged neutropenia, following transplantation or in conjunction with aggressive immunosuppressive regimens (eg, prolonged corticosteroid usage, chemotherapy). The incidence of IA is reported to vary from 5% to 20% depending on the patient population. IA has an extremely high mortality rate of 50% to 80% due in part to the rapid progression of the infection (ie, 1-2 weeks from onset to death). Approximately 30% of cases remain undiagnosed and untreated at death.
Definitive diagnosis of IA requires histopathological evidence of deep-tissue invasion or a positive culture. This evidence is often difficult to obtain due to the critically ill nature of the patient and the fact that severe thrombocytopenia often precludes the use of invasive procedures to obtain a quality specimen. The sensitivity of culture in this setting is low, reportedly ranging from 30% to 60% for bronchoalveolar lavage fluid. Accordingly, the diagnosis is often based on nonspecific clinical symptoms (unexplained fever, cough, chest pain, dyspnea) in conjunction with radiologic evidence (computed tomography scan); a definitive diagnosis is often not established before fungal proliferation becomes overwhelming and refractory to therapy.
Recently, a serologic assay was approved by the US Food and Drug Administration for the detection of galactomannan, a molecule found in the cell wall of Aspergillus species. Serum galactomannan can often be detected a mean of 7 to 14 days before other diagnostic clues become apparent, and monitoring of galactomannan can potentially allow initiation of preemptive antifungal therapy before life-threatening infection occurs.
Interpretation
A positive result supports a diagnosis of invasive aspergillosis (IA). Positive results should be considered in conjunction with other diagnostic procedures, such as microbiologic culture, histological examination of biopsy specimens, and radiographic evidence. See Cautions.
A negative result does not rule out the diagnosis of IA. Repeat testing is recommended if the result is negative but IA is clinically suspected. Patients at risk of IA should have a baseline serum tested and should be monitored twice a week for increasing galactomannan antigen levels.
Galactomannan antigen levels may be useful in the assessment of therapeutic response. Antigen levels decline in response to antimicrobial therapy.
Clinical Reference
1. Maertens J, Verhaegen J, Lagrou K, Boogaerts M: Screening for circulating galactomannan as a noninvasive diagnostic tool for invasive aspergillosis in prolonged neutropenic patients and stem cell transplantation recipients: a prospective evaluation. Blood. 2001 March 15;97(6):1604-1610
2. Pinel C, Fricker-Hidalgo H, Lebeau B, et al: Detection of circulating Aspergillus fumigatus galactomannan: value and limits of the Platelia test for diagnosing invasive aspergillosis. J Clin Microbiol. 2003 May;41(5):2184-2186
3. Swanink CM, Meis JF, Rijs AJ, Donnelly JP, Verweij PE: Specificity of a sandwich enzyme-linked immunosorbent assay for detecting Aspergillus galactomannan. J Clin Microbiol. 1997 Jan;35(1):257-260
4. Ansorg R, van den Boom R, Rath PM: Detection of Aspergillus galactomannan antigen in foods and antibiotics. Mycoses. 1997 Dec;40(9-10):353-357
5. Connolly P, Durkin M, Wheat LJ, et al: Rapid diagnosis of systemic and invasive mycoses. Clinical Microbiology Newsletter. 2007 Jan;29(1):1-5
Method Description
The Platelia Aspergillus enzyme immunoassay (EIA) is a 1-stage immunoenzymatic sandwich microplate assay that detects galactomannan in human serum. The assay uses the rat monoclonal antibody EBA-2, which is directed against Aspergillus galactomannan. The monoclonal antibody is used to coat the wells of the microplate and bind the antigen and as the detector antibody in the conjugate reagent (peroxidase-linked monoclonal antibody).
Serum Samples are heat-treated in the presence of EDTA to dissociate immune complexes and to precipitate serum proteins that could possibly interfere with the test. The treated serum samples and conjugate are added to the wells coated with the monoclonal antibody and incubated. A monoclonal antibody-galactomannan-monoclonal antibody/peroxidase complex is formed in the presence of Aspergillus antigen.
The strips are washed to remove any unbound material, and the substrate solution is added, which will react with the complex bound to the well to form a blue color reaction. The enzyme reaction is stopped by the addition of acid, which changes the blue color to yellow. The optical absorbance of specimens and controls is determined with a spectrophotometer set at 450 nm and 620/630 nm wavelengths.
Negative, cutoff (low-positive), and high-positive controls are analyzed each time the assay is performed. The presence or absence of Aspergillus galactomannan antigen in the test sample is determined by calculation of an index for the specimen. The index is the optical density (OD) value of the specimen divided by the mean OD of wells containing the cutoff control serum (low-positive control).(Package insert: Platelia Aspergillus EIA. Bio-Rad Laboratories; 10/2020)
Report Available
1 to 4 daysSpecimen Retention Time
2 weeksReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
Method Name
Enzyme Immunoassay (EIA)