Aspergillus Galactomannan EIA

Test Code: 1600

Aspergillus Galactomannan EIA test

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Clinical and Procedure
Clinical Utility

The Platelia™ Aspergillus Galactomannan EIA is a test, when used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy specimens, and radiographic evidence that can be used to aid in the diagnosis of Invasive Aspergillosis. Twice weekly monitoring of neutropenic patients is often recommended in the peer-reviewed literature to obtain maximum diagnostic utility of the assay.

About Aspergillus Galactomannan

Invasive aspergillosis is a common opportunistic fungal infection in patients who are profoundly neutropenic, either as a result of chemotherapy or after having received hematopoietic stem cell or solid organ transplantation.1 Prevalence of invasive aspergillosis is 1–15% and mortality can exceed 90%.2 Early diagnosis of invasive aspergillosis remains a challenge, but screening of patients in the early stage of infection may be useful in establishing an early diagnosis and may result in improved outcomes.3

Procedure

This test is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric CSF, bronch wash, BAL and serum samples. The assay uses EBA-2 monoclonal antibodies which detect Aspergillus galactomannan. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration for bronch wash, BAL and serum specimens only.

Turnaround Time

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
CSF 1603 87305 Yes

2 mL (min. 0.5 mL)
  • The reference range is an index of <0.5. Numerical index values will be reported.
  • Patients with an index of ≥0.5 are considered to be positive for galactomannan antigen.
  • Patients with an index of <0.5 are considered to be negative for galactomannan antigen.
  • Specimens testing positive will be retested to confirm the positive result.
  • A reference Index Value of <0.5 has been shown to be appropriate for both serum and bronchial lavage specimen types.
  • Collect in a sterile, screw-top tube.
  • Specimen should be stored refrigerated for no more than 7 days from collection or frozen (-20oC or lower) for no more than 7 days.
  • Ship on ice pack or frozen for overnight delivery. Monday through Friday.
BAL 1609 87305 Yes

2 mL (min. 0.5 mL)
  • The reference range is an index of <0.5 numerical index values will be reported.
  • Patients with an index of ≥0.5 are considered to be positive for galactomannan antigen.
  • Patients with an index of <0.5 are considered to be negative for galactomannan antigen.
  • Specimens testing positive will be retested to confirm the positive result.
  • A reference Index Value of <0.5 has been shown to be appropriate for both serum and bronchial lavage specimen types.
  • Collect in a sterile, screw-top tube.
  • Specimen should be stored refrigerated for no more than 5 days from collection or frozen (-20oC or lower) for no more than 30 days.
  • Ship on ice pack or frozen for overnight delivery. Monday through Friday.
Serum (1) 1610 87305 Yes

2 mL (min. 0.5 mL)
  • The reference range is an index of <0.5. Numerical index values will be reported.
  • Patients with an index of ≥0.5 are considered to be positive for galactomannan antigen.
  • Patients with an index of <0.5 are considered to be negative for galactomannan antigen.
  • Specimens testing positive will be retested to confirm the positive result.
  • A reference Index Value of <0.5 has been shown to be appropriate for both serum and bronchial lavage specimen types.
  • Collect 3-5 mL blood specimen in a gel separator tube (SST) without anticoagulant.
  • Allow specimen to clot, then centrifuge specimen within two hours of draw. Minimum volume is 2 mL of serum.
  • Specimens may be stored for up to 30 days at ambient or refrigerated (2-8oC).
  • Samples may be stored frozen (-20oC or greater) in a plastic pour-off tube.
  • Ship specimens at ambient, on ice pack, or frozen for overnight delivery. Monday through Friday.
bronch wash 1626 87305 Yes

2 mL (min. 0.5 mL)
  • The reference range is an index of <0.5. Numerical index values will be reported.
  • Patients with an index of ≥0.5 are considered to be positive for galactomannan antigen.
  • Patients with an index of <0.5 are considered to be negative for galactomannan antigen.
  • Specimens testing positive will be retested to confirm the positive result.
  • A reference Index Value of <0.5 has been shown to be appropriate for both serum and bronchial lavage specimen types.
  • Collect in a sterile, screw top tube.
  • Specimen should be stored refrigerated for no more than 5 days from collection or frozen (-20oC or lower) for no more than 30 days.
  • Ship on ice pack or frozen for overnight delivery. Monday through Friday.

Diagnosis and Monitoring

For maximum sensitivity, the test should be performed at least twice weekly during neutropenia. The exact frequency of testing in non-hospitalized patients with chronic graft-versus-host-disease (CGVHD) would depend upon the degree of immunosuppression. The test should be used in conjunction with other diagnostic procedures.

Two consecutive positive results are required for classification as true positive, thus it is recommended that a follow-up specimen be submitted from the patient upon receipt of the initial positive result; ideally prior to initiation of anti fungal therapy to achieve maximum specificity.

Assay Limitations

A negative test result cannot rule out the diagnosis of Invasive Aspergillosis. Patients at risk for Invasive Aspergillosis should be tested twice per week.

If a positive result is obtained, a second specimen should be collected and sent for testing immediately.

The performance of the test has not been evaluated with neonatal specimens.

This test may exhibit reduced detection in patients with chronic granulomatous disease and Job’s Syndrome.

The concomitant use of mold-active, anti fungal therapy in some patients with Invasive Aspergillosis may result in reduced sensitivity of the test.

There are reports in the literature of positive galactomannan test results in patients receiving piperacillin/tazobactam,therefore, results in these patients should be interpreted with caution and confirmed with other diagnostic methods.

There are reports in the literature of positive galactomannan test results in patients with intestinal mucositis caused by chemotherapy and irradiation, which allows for extra absorption of dietary galactomannan.

False-positive Galactomannan results have been shown in patients receiving Plasmalyte for intravenous hydration or if Plasmalyte is used for BAL collection.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10, Lenexa, KS 66219

Causes for Rejection

Specimens received outside recommended storage conditions. Specimens received grossly lipemic, icteric, hemolyzed. For BAL and Bronch wash, do not ship samples in trap containers.


Note: Freezing serum in SST tubes can lead to hemolysis and is not recommended.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Eurofins Viracor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

Information derived from the Platelia™ Aspergillus EIA package insert (Bio-Rad Laboratories). Aspergillus Galactomannan EIA is a product of Bio-Rad Laboratories.

References

1 Ascioglu S, Rex JH, de Pauw B, et al. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002;34:7–14.2.

2 Walsh TJ, Anaissie EJ, Denning DW, et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis.2008;46:327–60.3.

3 Pfeiffer CD, Fine JP, Safdar N. Diagnosis of invasive aspergillosis using a galactomannan assay: a meta-analysis. Clin Infect Dis. 2006;42:1417–27.

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