Aspergillus Galactomannan Antigen Detection, Cerebrospinal Fluid

TEST: 183858
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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).

Expected Turnaround Time

1 - 4 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

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Specimen Requirements

Specimen

Cerebrospinal fluid (CSF)

Volume

2 mL

Minimum Volume

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

Container

Sterile screw-cap, leak proof container

Caution against submitting pour-off specimens or specimens sent in non-sterile containers as this can lead to false positive results.

Collection

Collect specimen using aseptic technique. Avoid opening the specimen after collection. Do not aliquot (Package insert (PI) specifies transport in sealed tubes).

Storage Instructions

Storage: Refrigerate unopened at 2°C to 8°C for five days. After opening, store at 2°C to 8°C for 48 hours. Freeze at: -70°C after five days.

Stability: Not stable at room temperature. Stable refrigerated when unopened for five days. Stable opened for 48 hours.

Patient Preparation

Usual aseptic technique

Causes for Rejection

Unlabeled specimen or name discrepancy between specimen and test request form; insufficient volume of CSF (for BAL or serum see test 183805; BAL or serum received for test 183858 will default to the correct test number without informing the client); specimen sent in non-sterile containers (frozen specimens stored in unknown conditions may give false positive results due to contamination with fungus and/or bacteria)

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 β-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 test 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 0.5−1.0 have a lower predictive value than those with a value >1.0. No data are available for CSF. Results of this test are for investigational purposes only. The performance characteristics of this assay have been determined by LabCorp. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.

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. 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
183858 Aspergillus Ag, CSF 183859 Aspergillus Ag, CSF Index 53865-2
183858 Aspergillus Ag, CSF 511958 PDF 80563-0

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