Test Order

Balamuthia Molecular Detection
CDC-10474

Synonym(s)

Free-living ameba, parasite, granulomatous amebic encephalitis (GAE), B. mandrillaris

CDC Pre-Approval Needed

Julia Haston
(404)-718-1230
qdx2@cdc.gov

Ibne Ali
(404) 718-4157
xzn5@cdc.gov

Supplemental Information Required

Provide the following information: history of present illness, exposure history, past medical history, treatment history, CSF results, imaging results. Available images can be submitted for preliminary morphological diagnosis prior to submitting specimen for molecular identification. Contact dpdx@cdc.gov for more information about submitting images.

Supplemental Form

Not Applicable

Performed on Specimens from

Human and Animal

Acceptable Sample/ Specimen Type for Testing

For suspected cases of granulomatous amebic encephalitis (GAE) due to Balamuthia mandrillaris detected by Balamuthia molecular detection, brain tissue is the preferred specimen type; however, these amebae can occasionally be detected in cerebrospinal fluid (CSF; see 'Interference & Limitations' below). For suspected cases of Balamuthia skin lesion, skin tissue is an acceptable specimen.

Minimum Volume Required

0.2 g tissue; 1 mL fluids

Collection, Storage, and Preservation of Specimen Prior to Shipping

Tissue (in 0.5x PBS) or CSF should be stored refrigerated temperature (2-8°C) for up to 7 days, or frozen (-20°C or lower, in absence of PBS buffer) for up to 60 days.

Transport Medium

Small piece of tissue should be transported in small amount of 0.5x PBS to prevent dryness.

Specimen Labeling

Test subject to CLIA regulations and requires two primary patient identifiers (e.g., patient first and last name, date of birth, unique patient identifier from time of collection, such as medical record number) on the specimen container and on the test requisition.

Shipping Instructions which Include Specimen Handling Requirements

CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday – Friday. Shipping frozen is strongly recommended. Frozen specimens should only be sent with dry-ice by overnight priority mail and received within 60 days of collection. Refrigerated specimens should be sent with refrigerated or frozen cold packs and received within 7 days of collection.

Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 54
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]

All samples must be shipped in accordance with all applicable local, state and federal regulations. Upon shipment, submitter should send an email to the CDC POC providing shipping company, shipped date and package tracking number.

Methodology

Real-time PCR

Turnaround Time

7 Days

Interferences & Limitations

Formalin-fixed specimens are not acceptable for molecular studies as formalin fixation may cause DNA degradation. Additionally, CSF is NOT the preferred specimen type for Acanthamoeba or Balamuthia detection, because a negative CSF test result does not completely rule out infections with these amebae.
Regarding testing of formalin-fixed specimens see Test Order CDC-10365 (Pathologic Evaluation of Tissues for Possible Infectious Etiologies) and contact pathology@cdc.gov.

Additional Information

For 24/7 diagnostic assistance, specimen collection guidance, shipping instructions, and treatment recommendations, contact the CDC Emergency Operations Center at (770) 488-7100.

CDC Points of Contact