The CL2 laboratories function as a support laboratory for clinical trials, as a referral laboratory for industry or collaborative research, and as an independently funded research laboratory in infectious diseases/immunology. CCfV laboratory operating procedures are based on the regulations and guidance of Health Canada, the US Food and Drug Administration (FDA), and International Council for Harmonization, and are made available to research partners.
LABORATORY SERVICES (subpage)
The laboratory is located in a restricted access wing of the hospital with 500 square feet of dedicated space and 2500 square feet of shared space. Our facilities include monitored and alarmed walk-in refrigerators for storing supplies as well as monitored and alarmed –80°C freezers for storing study samples.
The CTRC laboratory is equipped to handle large sample sizes and report results in a timely fashion. CTRC laboratory operating procedures are based on the regulations set out by the US Food and Drug Administration (FDA) for Clinical studies and are available upon request.
Reference standards, obtained from the FDA and the World Health Organization, are used to standardize our methods to correspond to accepted International Units or titers. In addition, the CTRC laboratory has participated in collaborative studies with the FDA and other laboratories, both corporate and research to analyze intra- and inter-laboratory variation. Quality assurance for the laboratory involves personnel independent of the center.
Detailed costing and time estimates are available for large sample numbers. Our laboratory personnel have the appropriate qualifications and experience to perform the following:
Specimen handling, tracking, storage and certified shipping, certified PBMC isolation, ELISA for antibodies to:
- Pertussis – Pertussis Toxin, Filamentous Hemaglutinin, Pertactin, Fimbriae
- Streptococcus pneumoniae
As well as:
- PCR for Bordetella pertussis and Bordetella parapertussis
- CHO Assay
- Diphtheria Microneutralization Assay
- Tissue and Bacterial Culture
- PCR for Influenza virus detection and sub-typing
- Influenza virus culture
- Influenza Haemagglutination Inhibition Assay
- PCR for Streptococcus pneumoniae detection and serotyping