Production of Murine Diagnostic Reference Reagents

Period of Performance: 04/01/1989 - 11/30/1990


Phase 2 SBIR

Recipient Firm

Microbiological Associates, Inc.
Rockville, MD 20850
Principal Investigator


Microbiologically-defined mice and rats are required for sophisticated biomedical research. Serological procedures are the most feasible and economical means to monitor the health status of laboratory animals. A major problem arises when the results of various "test-kits" and in-house testing laboratories (government, industry and academia) are compared. The lack of standardization of test procedures and the unavailability of reference reagents (quality control) results in poor comparability and engenders a lack of confidence in laboratory animal health monitoring programs designed to safeguard the integrity of large studies involving very large sums of money. Microbiological Associates lnc. proposes to produce monospecific antisera to twenty-five (25) murine infectious agents (in addition to the 4 agents under Phase I) to be used as reference reagents in the standardization of serodiagnostic procedures (CF, HAl, ELlSA and IFA). A key feature of this proposal is the oversight, analysis and recommendations during all phases of the project by an independent Scientific Advisory Committee composed of experts in the fields of microbiology, immunology and laboratory animal medicine. The findings and recommendations of the committee will be publicized.