Aspergillus Galactomannan Antigen-Blood
Label Mnemonic: GALACMAN
Epic code: LAB2640
Downtime form: A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
Commercial Mailout Laboratory
6240-8 RCP
356-8593
Specimen(s):
Serum
Specimen Instructions:
Avoid exposure of specimen to atmosphere. Send specimen in original tube. Do not aliquot.
Collection Medium:
BD Gold SST 5 mL Vacutainer
Minimum:
1.5 mL serum
Rejection Criteria:
Lipemic or hemolyzed specimens. Avoid exposure of specimen to atmosphere. Send specimen in original tube. Do not aliquot. This test needs its own dedicated tube and cannot be shared with any other tests.
Turn Around Time:
1 day upon receipt at reference laboratory
Reference Range:
<0.5 index
Interpretive Data:
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 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.
Comments:
Useful For: An aid in the diagnosis of invasive aspergillosis and assessing response to therapy.

Cautions:
False-positive results are reported to occur at rates of 8% to 14% with this assay. For all positive patients, it is recommended that a new aliquot of the same specimen be repeated, as well as collection of a new specimen from the patient for follow-up testing. Two or more consecutive positive results should be obtained from separately drawn specimens before the patient is considered to have a positive Aspergillus antigen test.

Numerous foods (pasta, rice, etc.) contain galactomannan. It is thought that damage to the gut wall by cytotoxic therapy, irradiation, or graft- versus-host disease enables translocation of the galactomannan from the gut lumen into the blood and may be partially responsible for the high false-positive rate of this assay.

Other genera of fungi such as Penicillium and Paecilomyces have shown reactivity with the rat EBA-2 monoclonal antibody used in the assay. These species are rarely implicated in invasive fungal disease. Cross reactivity with Alternaria species also has been reported.

Semisynthetic antibiotics such as piperacillin, amoxicillin, and augmentin, which are based on natural compounds derived from the genus Penicillium, have been demonstrated to cross-react with the rat EBA-2 monoclonal antibody used in the assay.

The specificity of the assay for Aspergillus species cannot exclude the involvement of other fungal pathogens with similar clinical presentations such as Fusarium, Alternaria, and Mucorales.

The performance of the assay has not been evaluated with neonate serum specimens or for use with plasma or other specimen types such as urine or cerebrospinal fluid.

The assay may exhibit reduced detection of galactomannan in patients with chronic granulomatous disease and Job's syndrome.

The concomitant use of antifungal therapy in some patients with invasive aspergillosis may result in reduced sensitivity of the assay.

False-positive galactomannan results are possible in patients receiving PLASMA-LYTE for intravenous hydration or if PLASMA-LYTE is used for bronchoalveolar lavage.

Specimens containing Histoplasma antigen may cross-react in the Aspergillus galactomannan assay.
Methodology:
Enzyme Immunoassay (EIA)
CPT Code:
87305