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The new operative phrase in biohazard management is “Containment and Security”. In the wake of recent bioterrorist events, several rule changes were implemented that demand the attention of the entire Life science Community. These include rules issued under the Public Health Security and Bioterrism Preparedness Act and the USA PATRIOT Act, as well as proposed rule changes for mailing diagnostic and research specimens. If you possess, use, or mail any biological hazard, you should familiarize yourself with these rule changes. This paper will review the rule changes and make recommendations for compliance. (The J Histotechnol 26:67, 2003)Submitted and accepted January 13, 2003

The Laser Scanning Cytometer (LSC) is a relatively new class of instrument that combines features of both flow and image cytometry. The LSC is capable of measuring multicolor fluorescence, light scatter, and the location of cells fixed to a glass slide. It is capable of automatically measuring a large number of cells with data displayed in real time. In addition, cell location is recorded so that cells of interest can be relocated for morphological examination and classification. The LSC is capable of measuring a wide variety of sample types, including thin preps, cytospins, touch imprints, and tissue sections. In this brief review paper, the mechanics of laser scanning cytometry are examined along with potential applications to conventional histopathology. (The J Histotechnol 24:59, 2001)Submitted: September 9, 2000; Accepted with revisions: December 29, 2000

The Food and Drug Administration (FDA) is responsible for regulating the manufacture of in vitro diagnostic reagents. The level of regulation is linked to the level of risk posed by the product. Recently, the FDA published a proposed rule concerning the regulation of immunohistochemistry (IHC) reagents. The proposed rule states, in part, that the degree of risk to the patient associated with the use of IHC products depends on whether the product is used as an adjunct to conventional histopathology diagnostic techniques or provides information that is used independent of the conventional diagnostic process. The ruling makes no distinction on the basis of demonstrated use in basic research or clinical laboratory medicine. Under the proposed rule, manufacturers of IHC reagents would be required to submit a minimum of a premarket notification for each reagent. The premarket notification, or 510(k), imposes a time consuming and expensive regulatory hurdle. For purposes of comparison, biological stains ...

Immunohistochemical staining for the estrogen receptor can be influenced by a variety of technical variables, including degradation of staining with storage of tissue sections on glass slides. The epitope of the commercially available rat monoclonal antibody (H222, ER-ICA) has demonstrated a significant loss of immunoreactivity in tissue sections stored for 8 weeks. The purpose of the present investigation was to determine if the ERlD5 antibody is associated with a similar loss of reactivity. Tissue sections were stored on glass slides at room temperature for short (1–2 days) or long (>365 days) intervals prior to immunostaining with the ER1D5 antibody. Evaluation of immunostaining was performed by manual (microscopic assessment) and automated (image cytometry) methods. No difference in the intensity of the ER1D5 immunoreaction or the number of cells staining was observed by visual inspection. Although the mean summed optical density of ERlD5 staining was less in sections stored for long interval...