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Test Order
Test Order
Ehrlichia Molecular Detection
CDC-10499
Synonym(s)
Ehrlichia chaffeensis ehrlichiosis, human monocytic ehrlichiosis (HME), Ehrlichia ewingii ehrlichiosis, Ehrlichia muris euclairensis ehrlichiosis
CDC Pre-Approval Needed
None
Supplemental Information Required
Required information on the CDC 50.34 Specimen Submission Form:
- Test order name (one per submission form)
- SPHL point of contact including direct phone number of the person responsible for sample submission and follow-up
- Patient full name, sex, birth date
- Date of illness onset
- Specimen collection date
- Specimen source (e.g., serum, whole blood, eschar swab, tissue)
- Therapeutic agent and dates (specific antibiotic therapy and initiation date)
- State of illness
- Relevant clinical summary that includes signs and symptoms compatible with a rickettsial illness, as well as any pertinent comorbidities
Requested additional information:
- Other laboratory results (e.g., previous serologic or molecular tests, complete blood counts, hepatic transaminase levels or electrolyte values, if available)
- Travel history (within 2 weeks of symptom onset), denote with “No” or “Unknown” if no travel occurred or travel history is unknown)
- Exposure history, e.g., ticks, fleas, lice, mites, or relevant animal exposures (denote “None” or “Unknown” if no arthropod or animal exposure occurred or is unknown)
- Test order name (one per submission form)
- SPHL point of contact including direct phone number of the person responsible for sample submission and follow-up
- Patient full name, sex, birth date
- Date of illness onset
- Specimen collection date
- Specimen source (e.g., serum, whole blood, eschar swab, tissue)
- Therapeutic agent and dates (specific antibiotic therapy and initiation date)
- State of illness
- Relevant clinical summary that includes signs and symptoms compatible with a rickettsial illness, as well as any pertinent comorbidities
Requested additional information:
- Other laboratory results (e.g., previous serologic or molecular tests, complete blood counts, hepatic transaminase levels or electrolyte values, if available)
- Travel history (within 2 weeks of symptom onset), denote with “No” or “Unknown” if no travel occurred or travel history is unknown)
- Exposure history, e.g., ticks, fleas, lice, mites, or relevant animal exposures (denote “None” or “Unknown” if no arthropod or animal exposure occurred or is unknown)
Supplemental Form
None
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
Acute whole blood (taken within 14 days of illness onset or while patient remains febrile): EDTA-treated, or ACD A treated.
Acute serum: Serum separator tube, or cryo-tubes.
Tissue biopsies, including skin biopsy specimens from the site of rash or eschar.
Swab specimen of eschar, using a dry, sterile cotton swab (include eschar scab when available).
Samples must be collected within 72 hours of initiation of a tetracycline-class antibiotic, e.g., doxycycline (within 48 hours is preferred), or, if collection has occurred outside of this established time frame, patients must be symptomatic or with a residual eschar scab at the time of collection.
Acute serum: Serum separator tube, or cryo-tubes.
Tissue biopsies, including skin biopsy specimens from the site of rash or eschar.
Swab specimen of eschar, using a dry, sterile cotton swab (include eschar scab when available).
Samples must be collected within 72 hours of initiation of a tetracycline-class antibiotic, e.g., doxycycline (within 48 hours is preferred), or, if collection has occurred outside of this established time frame, patients must be symptomatic or with a residual eschar scab at the time of collection.
Minimum Volume Required
1.0 mL
Collection, Storage, and Preservation of Specimen Prior to Shipping
Keep specimen refrigerated (2-8°C) if sample will arrive at CDC within 7 days from collection. If the sample requires storage for more than 7 days prior to arriving at CDC, freeze at -20°C or lower up to 2 months (35 days for tissue), or -70°C or lower up to 1 year (for serum, blood, and tissue). For 2-8°C storage, tissue should be placed in a sterile specimen cup with a gauze pad slightly moistened with sterile saline. To freeze tissue, place specimen in a cryogenic container at -20°C or lower. Do not immerse the tissue in saline solution. For eschar swabs, place the specimen in a dry sterile specimen container without any medium.
Transport Medium
For tissue, place in sterile specimen cup with gauze pad lightly moistened with sterile saline. Do not immerse the sample in saline.
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 78
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.
Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 78
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
polymerase chain reaction (PCR), Real-time polymerase chain reaction (PCR), sequencing
Turnaround Time
6 Weeks
Interferences & Limitations
Molecular detection methods have decreasing sensitivity after resolution of the febrile (acute) stage of illness. Hemolysis of whole blood can interfere with results. Other shipping media is not recommended and will be subject to rejection. Multiple freeze-thaw cycles and sample storage above refrigerated temperatures (2-8°C) can interfere with nucleic acid extraction.
Additional Information
Routine diagnostic samples should be sent to your state public health laboratory (SPHL) or a commercial laboratory if the test is available commercially.
The Rickettsial Zoonoses Branch (RZB) Reference Diagnostic Laboratory assists state public health laboratories by providing specialized testing for rickettsial agents. Molecular testing for other pathogens including Anaplasma, Coxiella, Orientia, and Rickettsia spp. may be included following clinical review in RZB. Results are reported directly to SPHLs.
Additional RZB specimen and shipping information can be found at the following address:
https://www.cdc.gov/ncezid/dvbd/specimensub/rickettsial-shipping.html
The Rickettsial Zoonoses Branch (RZB) Reference Diagnostic Laboratory assists state public health laboratories by providing specialized testing for rickettsial agents. Molecular testing for other pathogens including Anaplasma, Coxiella, Orientia, and Rickettsia spp. may be included following clinical review in RZB. Results are reported directly to SPHLs.
Additional RZB specimen and shipping information can be found at the following address:
https://www.cdc.gov/ncezid/dvbd/specimensub/rickettsial-shipping.html
CDC Points of Contact
Version
2.7
Content Credential