Infectious Diseases

  • Laboratory for Specialized Clinical Studies

    We are dedicated to providing specialized laboratory testing to support clinical trials and investigations in the field of infectious diseases.

    A Range of Flexible Support

    The Laboratory for Specialized Clinical Studies (LSCS) has a 20-year history of providing support for clinical studies and vaccine trial services.  Our experience ranges from partnering with major pharmaceutical companies to providing personal attention to individual investigators working on smaller scale projects. 
    A sampling of the LSCS’s pediatric and adult clinical study experience includes rotavirus, influenza, cytomegalovirus (CMV), human calicivirus (HuCV) and other enteric and respiratory pathogens. 

    Providing Clinical Trial Services

    The LSCS conducts high-quality infectious disease and immunological testing to support clinical trials.  We also support the Cincinnati Children’s Hospital Medical Center as one of eight NIH-funded Vaccine Testing and Evaluation Units.  The laboratory capabilities include development and validation of customized assays and integration of customized statistical software.  All assays are conducted within the guidelines specified by College of American Pathologists (CAP) and quality laboratory standards.

    These cost-effective assays are performed at a high volume with rapid turnaround, utilizing state-of-the-art calibrated and controlled equipment.  Accurate and precise data are routinely generated for hundreds of test samples. Other features of our lab include:

    • Experience with vaccine clinical trials phases I-IV
    • All procedures conducted in a BL2 environment
    • High throughput and quick turnaround
    • CAP and CLIA accredited
    • Compliant with GLP guidelines
    • Fully auditable data to support submission of new or modified vaccines and biologics
    • Laboratory services are supported by a laboratory quality assurance officer and an independent Office of  Research Compliance and Regulatory Affairs.

  • Laboratory Testing Capabilities and Services

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    + Assay Development and Validation

    • Customized assay development for specific needs
    • Assay qualification and validation upon request

    + Influenza Capabilities

    • Influenza hemagglutination inhibition assay (HAI) 
    • Culture isolation and identification of influenza
    • Real-time PCR detection of influenza A and influenza B 
    • Influenza serum neutralizing antibody determination
    • Influenza fluorescent focus assay 
    • Anti-influenza IgG or IgA EIA

    + Rotavirus Capabilities

    • Rotavirus serum neutralizing antibody determination
    • Anti-rotavirus IgA determination
    • Anti-rotavirus serum IgG determination 
    • Detection of rotavirus antigen in stool samples
    • Culturing of rotavirus from clinical samples
    • Purification of rotavirus
    • Rotavirus fluorescent focus assay
    • Electropherotyping of rotavirus strains 
    • Genotyping and sequencing of rotavirus isolates
    • Rotavirus plaque assay

    + Norovirus Capabilities

    • Anti-norovirus IgG determination
    • Sensitive RT-PCR and sequencing methods for detection and identification of Norovirus in clinical samples

    + Cytomegalovirus Capabilities

    • Anti-gB antibody determination
    • Total anti-CMV IgG
    • Culturing of CMV from urine and saliva specimens
    • Real-time PCR detection and quantification of cytomegalovirus

    + Luminex Technology

    • Respiratory viral pathogen assay
    • Pneumococcal antibody determination
    • Cytokine quantification

    + PBMC Separation from Whole Blood

    • Trained staff with proven record for successful high-quality preparations of PBMC
    • Preparations can be stored on site in liquid nitrogen freezer or shipped to laboratories conducting CMI assays


 
  • Contact Us

    For more details about the LSCS at Cincinnati Children’s and how it may work with you, contact:

    Monica Malone McNeal
    Associate Director, LSCS
    Cincinnati Children’s Hospital Medical Center
    Phone: 513-636-7648
    Email: monica.mcneal@cchmc.org