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U.S. Department of Health and Human Services

Medical Devices

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Practice Caution in Using Bio-Rad Platelia™ Aspergillus EIA

FDA has cleared for marketing, the Platelia™ Aspergillus EIA, manufactured in France by Bio-Rad, Marnes-la-Coquette and distributed by Bio-Rad Laboratories, Redmond, WA, which detects Aspergillus galactomannan antigen in serum samples, and is an aid in the diagnosis of Invasive Aspergillus infection. Invasive Aspergillosis is a life-threatening invasive fungal infection that often occurs in leukemia patients, organ and bone marrow transplant patients, and patients whose immune systems are compromised by illness or chemotherapy.

There have been reports in the literature, in the U.S. and from Europe, of potential drug and device interaction that may occur when using the Platelia™ Aspergillus EIA galactomannan antigen assay to test sera from patients who are receiving piperacillin/tazobactam (Zosyn®), an injectable antibacterial combination product from Wyeth Pharmaceuticals, Inc. Recent reports [1] [2] have indicated that positive galactomannan antigen tests results may occur in serum samples from patients treated with Zosyn®, but without Invasive Aspergillosis. Additional studies have also demonstrated positive galactomannan antigen test results in certain batches of Zosyn®. These results are highly suggestive of reactivity of the Platelia™ Aspergillus EIA with Zosyn®. Nevertheless, as Platelia™ Aspergillus EIA can detect galactomannan antigen well before clinical or radiological signs appear, the occurrence of Invasive Aspergillosis cannot be ruled out. Therefore, patients treated with Zosyn® with positive test results should be followed carefully.

Bio-Rad has notified their customers and modified the Platelia™ Aspergillus EIA package insert to include a new Limitation of Use alerting laboratory users that positive test results in patients treated with Zosyn® should be interpreted cautiously and confirmed by other diagnostic methods.

It is therefore recommended that when reporting a positive Platelia™ Aspergillus EIA galactomannan test result, laboratories should inform physicians of the limitations of the test with regard to the potential interaction with Zosyn® and that the patient’s previous drug therapy should be taken into account.

FDA reminds users that life threatening or potentially threatening adverse device failures should be reported to the agency through MEDWATCH medical device reporting system. This may be done by visiting the MedWatch site or calling 1-800-FDA-1088. Less serious adverse device failures may be reported to the FDA by sending an e-mail to fdalabtests@cdrh.fda.gov.

References:

[1]Sulahian, A., S. Touratier, T. LeBlanc, P. Rousselot, F. Derouin, P. Ribaud. False Positive Aspergillus antigenemia related to concomitant administration of Tazocillin. Abstract M-2062a, 43rd ICAAC Program.

[2]Viscoli, C., M. Machetti, C. Cappellano, B. Bucci, P. Bruzzi, A. Bacigalupo. False-Positive Platelia Aspergillus test in patients receiving Piperacillin/Tazobactam. Abstract M-2062b, 43rd ICAAC Program.