The Host-Microbiome Center’s CLIA Testing unit manages the sample logistics, processing and storage. With dedicated space in the clinical laboratories and Center for Advanced Molecular Diagnostics (CAMD) at Brigham & Women’s Hospital, the unit offers CLIA-level (Clinical Laboratory) handling for clinical trials and for diagnostic testing. The unit maintains a dedicated LIMS (laboratory information management system) for sample tracking, and for registering consented patients under IRB protocols. A local freezer farm maintains CLIA-level storage of samples including stool, blood and other fluids and derivatives, nucleic acids and microbial isolates. The unit provides coverage for clinical processing M-F 8AM-8.30PM with offshift/weekend coverage of Center-approved protocols by BWH Lab Control.
In addition, the unit handles the collection of discarded/excess clinical lab materials for research use from the BWH Clinical laboratories and BWH/DFCI Kraft Family Blood Donor Center. Staff are available to discuss requirements for IRB and Biosafety protocols.
Services Offered:
Processing:
- Assistance with project and protocol development
Processing of consented patient samples documentation
- Processing of consented patient samples
- High-throughput DNA extraction and quantitation
- CLIA testing services (see CLIA Testing page)
- Short and long-term -20°C and -80°C storage in monitored freezer farm
- CLIA-level -80 storage of fluids and tissue blocks
Discarded clinical materials (requires appropriate IRB and/or Biosafety approval from the investigator’s home institution)
- Microbiologic primary specimens including: urine, CSF, sputum, stool and other sources
- Microbial isolates
- Fluids: blood, urine, CSF, stool
- Blood donation by-products: apheresis leukoreduction collars (source of fresh
Discarded whole blood samples WBCs), expired blood, plasma or platelet units.
CLIA-level Testing:
- Screening of samples for multi-drug resistant organisms (MDRO) including CRE, ESBL, MRSA and VRE
- Clostridium difficile stool testing by PCR, rapid toxin ELISA and in vitro cytotoxicity assay
- Assays offered in the BWH Clinical Laboratories are also available through the CLIA Testing Unit. Testing includes standard hematology, clinical chemistry and immunologic testing.
RUO (Research Use Only) testing:
- Calprotectin stool ELISA
- Pathogen genome sequencing and analysis