Laboratory Guidance Overview
Information on this site is focused on important laboratory findings and guidance related to the outbreak of fungal meningitis and other infections linked to the use of injectable steroids from three recalled lots of preservative-free methylprednisolone acetate (MPA) distributed by the New England Compounding Center (NECC).
For more information on the outbreak, see the Multistate Fungal Meningitis Outbreak Current Situation page. For information about laboratory results on NECC medications other than three lots of preservative-free MPA, see Information about Additional Medical Products (non-MPA) From New England Compounding Center.
- Three laboratories at CDC are working in coordination with state public health departments and clinicians to find out more about fungal infections in patients exposed to three lots of recalled preservative-free MPA.
- Several laboratory experts and offices are working together on reviewing laboratory findings. All of these laboratories use a number of sophisticated testing methods including electron microscopy, polymerase chain reaction (PCR) amplification and sequencing of DNA, and MALDI-TOF mass spectrometry analysis.
- The Mycotic Diseases Branch Fungus Reference Laboratory is conducting tests to detect fungal agents in CSF, joint fluid, and tissues from patients, and is confirming the identification of fungi isolated from patient specimens.
- The Infectious Diseases Pathology Branch laboratory is examining tissues from biopsy and autopsy materials to confirm the presence of fungi and to document the pathology in human tissues.
- The Clinical and Environmental Microbiology Branch laboratory has conducted sterility testing on various products from the NECC and Ameridose pharmacies.
- Little information is known about the disease and pathogenesis caused by Exserohilum, the predominant pathogen associated with this outbreak.
Testing and Results
- Laboratory Testing and Results
- Diagnostic Testing for Septic Arthritis and Specimen Submission to CDC — Outbreak Associated with Injection of Potentially Contaminated Steroid Products
- Diagnostic Testing and Specimen Shipping for Central Nervous System and Parameningeal Infections
Publications and Resources
CDC Morbidity and Mortality Weekly Report (MMWR)
- MMWR: Multistate Outbreak of Fungal Infection Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy — United States, 2012
- MMWR: Multistate Fungal Meningitis Outbreak — Interim Guidance for Treatment
- Frequently Asked Questions for Patients
- CDC Digital Press Kit with Laboratory Photos and Footage
- CDC Fungal Diseases
- CDC Fungal Meningitis
- CDC Information About Additional Medical Products (non-MPA) From New England Compounding Center
- CDC Information About Voluntary Recall of All Ameridose Medical Products
- Gade L, Scheel CM, Pham CD, et al. Detection of fungal DNA in human body fluids and tissues during a multistate outbreak of fungal meningitis and other infections. Eukaryotic Cell 2013 Mar.
- Kainer MA, Reagan DR, Nguyen DB, et al. Fungal infections associated with contaminated methylprednisolone in Tennessee. New Engl J Med 2012 Nov.
- Lyons JL, Gireesh ED, Trivedi JB, et al. Fatal Exserohilum meningitis and central nervous system vasculitis after cervical epidural methylprednisolone injection. Ann Intern Med 2012 Oct.
- Pettit AC, Kropski JA, Castilho JL, et al. The index case for the fungal meningitis outbreak in the United States. NEJM 2012 Oct.
U.S. Food and Drug Administration (FDA)
- FDA Statement on Fungal Meningitis Outbreak
- Questions and Answers on Fungal Meningitis Outbreak
- List of Recalled Products Related to Fungal Meningitis Outbreak
- Alert — New England Compounding Center Product Recall Information (Commonwealth of Massachusetts) [PDF - 4 pages]