THE LAI High Capacity Slide Analysis Micronucleus Assay (HCSA MNA) system automates the scoring of the In Vivo Mouse Micronucleus Assay. The micronucleus assay is one of the most widely used tests for mutagenesis and potential carcinogenesis required by regulatory agencies for testing of genetic toxicity in regulated substances, during pre-clinical assessment of pharmaceuticals. The LAI Automated Micronucleus Assay System automatically finds and categorizes micronucleated cells in bone marrow or peripheral blood preparations.

The LAI HCSA MNA software is designed to search prepared slides to find cells, target potential micronucleated cells, and discriminate between PCEs and NCEs. A camera attached to the microscope acquires images as directed by the software. Each image is scanned and the LAI HCSA MNA software performs automated unbiased discrimination and scoring of micronucleated PCEs and NCEs in Giemsa stained bone marrow or peripheral blood preparations. Micronucleated cells found by the system can be automatically relocated under the microscope eyepieces and reviewed by the user.

Reports are available immediately after scoring of the experiment is complete, eliminating transcription errors and the time necessary for statistical analysis completion. The system accommodates the existence of non-target (non PCE or NCE) cells and ignores non-target cells in analysis.

Through GLP validation, test results show there is no statistical difference between manual scoring and the Automated Micronucleus Assay System, while the per dose variance is significantly reduced. The quantitative repeatability in discriminating erythrocytes by color-discrimination by scoring the same experiment/slide multiple times using the automated micronucleus system has also been demonstrated.

Running a Study

- The investigator loads the study protocol, linking the slides with compound name and dose level for negative and positive controls and treatment, and slide or animal number.

- The user indicates the target number of cells to be found and indicates how many slides are to be used for each dose level. The system will automatically move to subsequent slides if inadequate numbers of cells are found on the current slide.

- The search parameters are loaded or created for each different slide preparation.

-The automated stage is fed by the 150 slide capacity delivery system, and can run overnight locating micronucleated PCEs or NCEs at 60x magnification.

-PCE and NCE counts, PCE to NCE ratio, micronucleated PCE and NCE counts, and micronucleated PCEs per 1000 are recorded, and thumbnail images of candidate "found" cells and the locations of those cells are saved for review.

- Next, individual cells can be automatically relocated and examined, and false positives visually eliminated from the count and statistics updated to reflect editing.

- At the end of the study, the investigator generates statistical data formatted for FDA submission.

GLP features

-Users sign in with Username and Password to gain access to the program. Users are set up in security levels for system administration, general use and review only.

-A study log of changes made to the study, including name and date of editing of false positives and date of scanning.

-The study can be locked to changes after editing is complete.

-Report pages are created as protected sheets in an Excel® workbook.