Temperature monitoring system for an automated biological...

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Reexamination Certificate

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C422S067000, C436S001000, C436S166000, C436S169000

Reexamination Certificate

active

06403036

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates generally to an automated biological reaction apparatus (“ABRA”). Two such ABRA's are shown in U.S. Pat. No. 5,595,707 (“'707 Patent”) and International Application No. PCT/US98/16604 (Pub. No. WO 99/08090), and the teachings thereof are fully incorporated herein by reference. More particularly, the present invention relates to a temperature monitoring system, including test glass slide, for use in an ABRA to verify proper operational temperature therein for each protocol.
The ABRA performs the steps of an immunohistochemical assay at the established temperature for the selected protocol. A glass slide, prepared with the tissue section under examination, carries a bar code readable by the ABRA to identify the selected protocol.
Under the regulations of the College of American Pathologists (“CAP”), any such ABRA must be tested periodically to verify that the temperature parameters of each protocol are met. At present, such testing and verification must be performed in accordance with the manufacturer's specifications. To-date, such testing requires a qualified service technician and typically results in several hours of “down time” for the ABRA. In extreme situations, the ABRA is rendered “inoperative” until a service call can be scheduled.
SUMMARY OF THE INVENTION
In a principal aspect, the present invention is a system for monitoring the temperature experienced by a glass slide in an ABRA, which allows CAP verification by the ABRA user directly, without the need for a qualified service technician. The system includes low and high temperature-sensitive indicators attached to the glass slide at predetermined locations. Each temperature-sensitive indicator has a threshold and an initial visual state. Each indicator changes to an altered visual state whenever subjected to a temperature at or above its threshold.
The system further includes a bar code, affixed to the glass slide and readable by the ABRA to set the selected protocol, which defines a specified temperature range. The low and high temperature thresholds correspond generally to the specified temperature range for the protocol.
It is thus an object of the present invention to provide easy, user-based testing of an ABRA. Another object is a test glass slide to quickly and inexpensively determine the operational state of an ABRA. Yet another object is readily manufactured test glass slide to determine the temperature applied to a tissue specimen in an ABRA and to provide permanent record thereof.
These and other features, objects and advantages of the present invention are set forth or apparent in the following detailed description.


REFERENCES:
patent: 3214278 (1965-10-01), Mylo
patent: 4912304 (1990-03-01), Philippbar
patent: 5215378 (1993-06-01), Manske
patent: 5254473 (1993-10-01), Patel
patent: 5595707 (1997-01-01), Copeland et al.
patent: RE35716 (1998-01-01), Stapleton et al.
patent: 0819750 (1997-07-01), None
patent: 2665957 (1992-02-01), None
patent: 1600062 (1981-10-01), None
patent: WO 99/08090 (1999-02-01), None
Omega Engineering, Inc. The Omega Complete Temperature Measurement Handbook and Encyclopedia, 1989.

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