Cincinnati Center for Clinical Research

Laboratory for Specialized Clinical Studies (LSCS) Overview

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Tour the Laboratory for Specialized Clinical Studies (LSCS)

Landmark Experience in Laboratory Studies

Cincinnati Children's Laboratory for Specialized Clinical Studies (LSCS) has conducted virological and immunological laboratory studies with clinical trials for more than 20 years. Since 1990, a major focus of the laboratory has been with rotavirus vaccine and influenza vaccine trials. The LSCS has been the central laboratory analyzing more than 100,000 specimens for virtually all major Phase I, II and III rotavirus vaccine trials conducted worldwide. During these trials, the laboratory has not only conducted the analyses, but also has been the long-term repository for most specimens. The rotavirus vaccine studies are being performed through affiliations with biotechnology and pharmaceutical organizations that include (among others) Merck, GlaxoSmithKline and Wyeth-Ayerst.

The LSCS also supports Cincinnati Children's as one of seven NIH-funded Vaccine and Treatment Evaluation Units (VTEU) sites in the United States actively involved in current NIH sponsored vaccine studies.

***The LSCS welcomes new partnerships with bio- and pharmaceutical organizations for future laboratory and clinical studies.***

Our Services

The LSCS conducts specialized procedures for numerous pediatric and adult vaccine clinical evaluations with enhanced bioanalytical methods including:

Extensive viral culture, isolation and serology experience - rotaviruses, influenza viruses, cytomegaloviruses, respiratory syncytial virus, rhinoviruses, coxsackieviruses, polioviruses, astroviruses, mumps virus and others.
Standardized, validated immunoassays for the quantitative detection of antibodies designed to support clinical trials
Standardized, validated assays for quantitative and qualitative detection of antigens designed to support clinical trials
Functional assays to determine neutralizing antibody titers
Traditional methods for anti-viral antibody evaluation e.g. HAI
In vitro cell-based bioassays and fluorescence assays
Protein quantification and characterization through spectroscopy and SDS-PAGE
Viral nucleic acid isolation and detection
Integration of customized statistical software programs

Quality Assurance and Training

Our laboratory operates under GLP guidelines with assistance from an independent Regulatory Affairs Department.

Our staff is trained to work in a GLP environment to meet the regulatory requirements for this type of testing and is also HIPAA trained.
The laboratories are approved for Biosafety Level 2 (BL2) physical and biological containment (access to Biosafety Level 3 containment laboratory facilities is available)
Technical staff is fully trained to observe BL2 lab practice and handle infectious pathogens
All assays are validated and conducted within the guidelines specified by CAP. These cost-effective assays are performed at a high volume with expeditious turn-around time utilizing state-of-the-art calibrated and controlled equipment.
Accurate and precise test data is routinely generated on hundreds of test samples on a weekly basis.
Laboratory Quality Assurance staff provides thorough review of all data prior to release.
Extensive documentation on all procedures is securely maintained for audit purposes in compliance with regulatory guidelines.

LSCS Equipment and Facility

All equipment where necessary is calibrated and validated.
BL2 containment instituted with laboratory practice, containment equipment and laboratory design. Equipment is certified to meet Environmental Health and Safety Testing standards.
Large and well equipped laboratory area
Two separate tissue culture areas fully equipped with laminar airflow clean benches, Class II biosafety cabinets, and CO2 incubators.
Walk-in -20° C freezer room
Walk-in 37° C warm room
Extensive ultra-cold freezer storage
Automated liquid nitrogen storage
ADA compliant chemical fume hoods
Ultra-centrifuges
Sterilizer/autoclave
Automated immunoassay plate washers and plate readers to support high through-put immunoassays
Sterilizer
Self-contained glassware cleaning and preparation area
Secure long-term repository for human clinical specimens and viral stocks
State-of-the-art Rees Centron System monitors all controlled temperature units 24/7; alerting personnel of equipment or power failure
On-site security officers patrol this limited access facility 24/7, providing excellent security for both data and samples