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E. coli 0157:H7 And Other Toxin Producing Strains

Clinical Specimen Submission Guidance

Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM

Lab

E. coli 0157:H7 And Other Toxin Producing Strains

Analyte Name

Escherichia coli 0157:H7 or STEC (E. coli non-0157 Shiga-toxin positive)

Disease

E. coli infection (STEC)

Test Description

Genus and species identification of bacterial enteric pathogen

This test is performed using a laboratory developed real-time PCR assay for the detection of Shig-like toxin genes stx1 and stx2 from the shigatoxigenic serotypes of Escherichia coli. The performance characteristics of this assay were validated by the Rhode Island State Health Laboratories. It has not been approved nor cleared by the U.S. Food and Drug Administration.

Results are for epidemiological and investigational purposes only and may not be used as a substitute for diagnostic procedures nor to guide patient management decisions.

Specimen

Isolate: Pure isolated colonies (<48 hours old) on appropriate tube or plated media sealed with parafilm or other appropriate barrier film.

Enteric broth such as GN Broth (incubated for at least 24 hours at 35°- 37°C). Store broths refrigerated at 4°- 8°C prior to shipment.

Stool: PRIOR APPROVAL is required for all primary stool specimens. Contact the Molecular Diagnostics Laboratory at (401) 222-5538. Minimum volume 2 mL collected in Cary Blair Transport Media or other suitable transport media. Store refrigerated at 2°-8°C.

CLIA regulations require two patient identifiers on the specimen container and the test requisition

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

Enteric Pathogen Isolate:

For Culture - Write "E. coli 0157:H7" under Comments/Other test requests

For Broth: Write "STEC positive broth" under Comments/Other test requests

Transport

Transport within 48 hours of subculture at ambient temperature 25° - 35°C.

Specimens must be packaged & transported in accordance with current federal shipping regulations.

Containers specifically labeled for transport of specimens to the RISHL Molecular Diagnostic Laboratory are available in all Microbiology Labs and Laboratory Sendout Departments.

Reminder: STEC positive broth is 'Catagory A'. Shipments that meet the definition for 'Category A' infectious substances as defined by federal regulation require additional packaging/labeling.

Integrity

Pure isolate or STEC positive broth must be received

Normal Value

Negative for E. coli 0157:H7 or Shiga-toxin producing E. coli

Reporting Requirement

Providers must report patient information on E. coli infection (Shiga toxin-producing) within 4 days using the RIDOH reportable disease form.

Turnaround Time

Up to 7 business days