Carbapenem-resistant bacteria
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
Special Pathogens & Biothreats Laboratory 401-222-5586
Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii
Carbapenem-resistant Infection (CRE/CRPA)
CRE/CRPA: Collect, confirm, and characterize carbapenem-resistant Enterobacterales (CRE) and Pseudomonas aeruginosa (CRPA); non-mucoid CRPA only.
The modified Carbapenem Inactivation Method (mCIM) phenotypic assay and the GNX2F antimicrobial susceptibility panel (Sensititre) have not been approved nor cleared by the U.S. Food and Drug Administration and their performance characteristics were validated by the Rhode Island State Health Laboratories (RISHL).
The Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) Biotyper CA (Bruker Daltonics Inc.) and its reference library of species are cleared by the U.S. Food and Drug Administration (FDA) for the identification of microorganisms. The performance characteristics of the MALDI-TOF system were verified by the Rhode Island State Health Laboratories. Additional species not contained in the FDA-approved reference library were extensively validated prior to reporting.
Carbapenemase gene detection by real-time PCR is performed using the FDA-cleared Xpert Carba-R Assay (Cepheid). The performance characteristics of this assay were verified by the Rhode Island State Health Laboratories.
Per request of the CDC, CRAB (Carbapenem-resistant Acinetobacter baumannii) and other CRE by a novel mechanism (as determined by RISHL testing), isolates are being collected for shipment to the Regional Reference Laboratory for further characterization.
Results are for epidemiological and infection control purposes only and may not be used as a substitute for diagnostic procedures nor to guide patient management decisions.
Resistant CRE to at least one of the following: imipenem, meropenem, doripenem, ertapenem by standard susceptibility testing methods (i.e., minimum inhibitory concentrations of >=4 µg/mL for imipenem, meropenem, doripenem, or >=2 µg/mL for ertapenem)
OR
Positive for known resistance mechanism demonstrated by molecular testing
OR
Positive for a phenotypic test for carbapenemase production (e.g., metallo-B-lactamase test, modified Hodge test, Carba NP, Carbapenem Inactivation Method (CIM), or modified CIM)
Non-mucoid Pseudomonas aeruginosa or Acinetobacter baumannii resistant to imipenem, meropenem, or doripenem by standard susceptibility testing methods (i.e., minimum inhibatory concentrations of >=8 µg/mL)
Preferred: an 18-24 hour pure isolate on a blood agar plate sealed with parafilm or other appropriate barrier film.
If transport is delayed, minimize excessive subculturing and keep plate refrigerated at 2-8°C to preserve resistance mechanism.
CLIA regulations require specimens be labeled with at least two patient identifiers. Examples of identifiers are first and last name, date of birth, chart/medical record number. The specimen container must be labeled to match the test requisition or the electronic order.
Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf
Copies of all susceptibility and mechanistic testing reports.
CRE/CRPA Isolate
Write CRE - (microorganism name), CRPA, or CRAB under Comments/Other test requests. Include travel history (if known).
Indicate whether the isolate is derived from a clinical or screening/surveillance culture.
Specimens must be packaged & transported in accordance with current federal shipping regulations.
Refrigerated: Transport in a yellow-top transport container and deliver to the laboratory within 24 hours of collection at 2-8°C in a cooler able to maintain specimen temperature. A plug-in electric cooler is recommended, however, a cooler packed with excess frozen gel packs is acceptable as long as the transport temperature is maintained at 2-8°C.
Providers must report patient information on Carbapenem-resistant Infection within 4 days using the RIDOH reportable disease form.
7 business days
Containers specifically labeled for transport of specimens and isolates to the RISHL Special Pathogens and Biothreats Laboratory are available in all Microbiology Laboratories and Laboratory Sendout Departments.