Aspergillus Galactomannan Antigen Detection, Bronchoalveolar Lavage or Serum

CPT: 87305
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Special Instructions

Avoid opening the specimen after collection. Do not aliquot (package insert (PI) specifies transport in sealed tubes). The client must submit the patient's Social Security number for serial monitoring.


Expected Turnaround Time

1 - 5 days



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Specimen Requirements


Specimen

Serum or bronchoalveolar lavage (BAL)


Volume

2 mL


Minimum Volume

0.35 mL (Note: This volume does not allow for repeat testing.)


Container

Serum: Red-top tube (refrigerated) or gel-barrier serum separator tube (SST) (refrigerated or spun down and frozen); pour-off specimens and specimens sent in non-sterile containers will be rejected due to the risk of false positive results

BAL: Leakproof sterile container with screw cap

Note: Submissions in non-sterile containers or containers without a secure screw cap will be rejected.


Collection

Serum: Collect using aseptic technique. Note: Pour-off specimens and specimens sent in non-sterile containers will be rejected due to the risk of false positive results.

BAL: sterile screw-cap, leakproof container. If an aliquoting step cannot be avoided, aliquot within a well-maintained biosafety cabinet using sterile technique. Avoid opening the specimen after collection to prevent contamination with fungal spores and/or bacteria present in the environment.


Storage Instructions

Serum: Refrigerate unopened for up to five days. Separated serum may be frozen at -70°C.

BAL: Refrigerate up to 24 hours; frozen (-20°C or colder) for up to five months.


Stability Requirements

Temperature

Period

Room temperature

Not stable (stability provided by manufacturer or literature reference)

Refrigerated

Serum (unopened): 5 days; BAL: 24 hours (stability provided by manufacturer or literature reference)

Frozen

Serum (unopened, spun down): -70°C up to 5 months; BAL: -20°C or less up to 5 months (stability provided by manufacturer or literature reference)

Freeze/thaw cycles

Stable x4 (stability provided by manufacturer or literature reference)


Patient Preparation

Usual aseptic technique


Causes for Rejection

Unlabeled specimen or name discrepancy between specimen and test request form; blood collected in collection tubes other than those specified; frozen whole blood, grossly hemolyzed, lipemic or icteric blood specimens; respiratory specimens other than BAL; inadequate specimen volume; BAL received in container without screw-cap lid (for example, trap container); leaking BAL specimens; specimen received after the specified time or improperly stored/transported; specimen source other than BAL or serum (for CSF, see Test No. 183858; CSF received for Test No. 183805 will default to the correct test number without informing the client); specimen received in non-sterile containers (note that most pour-off containers and snap cap lids are non-sterile)


Test Details


Use

Patients diagnosed with chronic granulomatous disease and/or Job's syndrome may yield a reduced detection of galactomannan.1 Reduced assay sensitivity may occur in patients receiving concomitant antifungal therapy.2 Penicillium species, Alternaria species, Paecilomyces species, Geotrichum species, and Histoplasma species have demonstrated reactivity with the monoclonal antibodies used in the assay and may, therefore, yield a positive test result. Positive results in patients with no clinical signs of disease have been reported, especially in young children.3 Most of these are considered to be false positives. Young children may have a positive assay result due to the presence of galactofuranaase contained in various foods (cereals) and milk. Patients receiving piperacillin/tazobactam or semisynthetic beta-lactamase therapy may have false-positive results.4,5 False-positive results may also occur with use of PLASMA-LYTE™ for either intravenous hydration or BAL specimen collection.6


Limitations

A negative result does not exclude the possibility of invasive aspergillosis. Patients at risk for invasive aspergillosis should be tested twice weekly. Results close to the cutoff (ie, index of 0.5) should be interpreted with caution and supported by clinical, radiological, or laboratory culture results. BAL samples with an index value between 0.5 and 1.0 have a lower predictive value than those with a value >1.0.


Methodology

Enzyme immunoassay (EIA)


Footnotes

1. Walsh TJ, Schaufele RL, Sein T. Abstracts of the 40th Annual Meeting of the Infectious Disease Society of America. Arlington, Va: 2002:1-5. Abstract 345.
2. Marr KA, Laverdiere M, Gugel A, Leisenring W. Antifungal therapy decreases sensitivity of the Aspergillus Galactomannan enzyme immunoassay. Clin Infect Dis. 2005 Jun 15; 40(12):1762-1769. 15909264
3. Siemann M, Koch-Dörfler M, Gaude M. False-positive results in premature infants with the Platelia Aspergillus sandwich enzyme-linked immunosorbent assay. Mycoses. 1998 Nov; 41(9-10):373-377. 9916459
4. Viscoli C, Machetti P, Cappellano P, et al. False-positive Galactomannan platelia Aspergillus test results for patients receiving piperacillin-tazobacter. Clin Infect Dis. 2004 Mar 15; 38(6):913-916. 14999640
5. Bart-Delabesse E, Basile M, Al Jijakli A, et al. Detection of Aspergillus galactomannan antigenemia to determine biological and clinical implications of beta-lactam treatments.J Clin Microbiol. 2005 Oct; 43(10):5214-5220. 16207986
6. Hage CA, Reynolds JM, Durkin M, Wheat LJ, Knox KS. Plasmalyte as a cause of false-positive results for Aspergillusgalactomannan in bronchoalveolar lavage fluid. J Clin Microbiol. 2007 Feb; 45(2):675-677. 17166959

References

Alexander BD, Pfaller MA. Contemporary tools for the diagnosis and management of invasive mycoses. CID 2006; 43(Suppl 1):S15-S27.
Gentry LO, Wilkinson ID, Lea AS, Price MF. Latex agglutination test for detection of Candida antigen in patients with disseminated disease. Eur J Clin Microbiol. 1983 Apr; 2(2):122-128. 6861734
Pinel C, Fricker-Hildalgo B, 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. 12734275

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
183805 Aspergillus Ag, BAL/Serum 62467-6 183807 Aspergillus Ag, BAL/Serum Index 62467-6
183805 Aspergillus Ag, BAL/Serum 62467-6 511958 PDF 80563-0

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