Clinical Trials Support

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:


  • Assistance with project and protocol development
    Processing of consented patient samples


  • 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