Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Means for analyzing liquid or solid sample
Reexamination Certificate
1998-10-13
2001-07-17
Warden, Jill (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Means for analyzing liquid or solid sample
C422S063000, C422S065000, C422S066000, C422S082080, C436S043000, C436S044000, C436S046000, C436S047000, C436S164000, C436S169000, C356S445000, C356S446000, C356S222000, C356S425000
Reexamination Certificate
active
06261522
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an apparatus and method for performing tests on a sample of body fluid to be analyzed, and more particularly to a spectrophotometer and method for the automatic detection of a reagent strip.
It is useful for various medical diagnostic purposes to utilize a spectrophotometer to analyze samples of body fluid, for example, to determine the color of a person's urine. A conventional spectrophotometer determines the color of a urine sample disposed on a white, non-reactive pad by illuminating the pad and taking a number reflectance readings from the pad, each having a magnitude relating to a different wavelength of visible light. The color of the urine on the pad may then be determined based upon the relative magnitudes of red, green and blue reflectance signals.
Conventional spectrophotometers may be used to perform a number of different urinalysis tests utilizing a reagent strip on which a number of different reagent pads are disposed. Each reagent pad is provided with a different reagent which causes a color change in response to the presence of a certain type of constituent in urine, such as leukocytes (white blood cells) or red blood cells. Such a reagent strip may have ten different types of reagent pads.
In a conventional spectrophotometer, the process of inspecting a reagent strip is performed by dipping the reagent strip in a urine sample, blotting excess urine from the reagent strip, placing the reagent strip at a designated location in the spectrophotometer, and pressing a start button which causes the spectrophotometer to begin automatic processing and inspection of the reagent strip.
U.S. Pat. No. 4,689,202 to Khoja, et al. discloses a reagent test strip reading instrument that has an area in which reagent strips may be placed and a blotter arm
108
that automatically moves reagent strips, one at a time, from the placement area towards an inspection area. As described in column
11
of the Khoja, et al. patent, the automatic movement of the blotter arm
108
is synchronized to the periodic movement of a strip advancing member
116
.
In a prior art reagent strip reading instrument marketed by the assignee of this patent under the name “Clinitek 200,” which instrument was designed generally in accordance with the disclosure of the Khoja, et al. patent, the blotter arm periodically swept across the area on which reagent strips were placed at a rate of about once every ten seconds, regardless of whether or not a reagent strip was present, and the instrument would generate an audible beep once for every sweep of the blotter arm. If no reagent strips were placed in the placement area after about two minutes, the blotter arm would cease its automatic movement. Thereafter, to again initiate the automatic movement of the blotter arm, the user would have to manually press a start button.
SUMMARY OF THE INVENTION
In one aspect, the invention is directed to an apparatus for automatically detecting the presence of a reagent strip having a body fluid sample disposed thereon and for inspecting the reagent strip after the presence of the reagent strip is detected. The apparatus includes a detection system adapted to automatically detect the presence of a reagent strip at a reagent strip receiving area, a light source adapted to illuminate the reagent strip after the presence of the reagent strip at the reagent strip receiving area is detected, and a detector adapted to receive light from the reagent strip when the reagent strip is being illuminated by the light source. The detection system is provided with a light emitting apparatus adapted to illuminate the reagent strip receiving area, a detecting apparatus adapted to receive light from the reagent strip receiving area while the reagent strip receiving area is being illuminated by the light emitting apparatus and to generate a detection signal relating to the amount of light detected from the reagent strip receiving area, and a circuit adapted to automatically determine whether a reagent strip is present at the reagent strip receiving area based on the magnitude of the detection signal.
The light emitting apparatus may be provided in the form of a plurality of light emitting diodes spaced to illuminate separate portions of the reagent strip receiving area, and the light detecting apparatus may include a plurality of light detectors spaced to detect light from a plurality of separate portions of the reagent strip receiving area. The light emitting apparatus may be adapted to sequentially illuminate different portions of the reagent strip receiving area at different times, and the light emitting apparatus may also be adapted to illuminate a reagent strip receiving area having a width at least about five times the width of a reagent strip.
The detection circuit, which may be in the form of a controller, may be adapted to automatically determine whether a reagent strip is present at the reagent strip receiving area based on a comparison of the magnitude of the detection signal with a threshold.
The invention is also directed to an apparatus for automatically processing a reagent strip having a body fluid sample disposed thereon which is provided with a detection system adapted to automatically detect the presence of a reagent strip at a reagent strip receiving area and a memory which stores signals relating to the amount of light detected from the reagent strip after the reagent strip is detected at the reagent strip receiving area. The detection system includes a light emitting apparatus adapted to illuminate the reagent strip receiving area, a detecting apparatus adapted to receive light from the reagent strip receiving area while the reagent strip receiving area is being illuminated by the light emitting apparatus and to generate a detection signal relating to the amount of light detected from the reagent strip receiving area, and a circuit adapted to automatically determine whether a reagent strip is present at the reagent strip receiving area based on the magnitude of the detection signal.
The apparatus may also include a conveyor system adapted to automatically move the reagent strip from the reagent strip receiving area to a reagent strip inspection location after the presence of the reagent strip is automatically detected by the circuit. The conveyor system may include a laterally moving arm which makes contact with a side of the reagent strip to force the reagent strip from the reagent strip receiving area towards the reagent strip inspection location.
In another aspect, the invention is directed to a method of automatically processing a reagent strip having a body fluid sample disposed thereon which includes the steps of: (a) automatically detecting the presence of a reagent strip at a reagent strip receiving area; (b) after the presence of the reagent strip is automatically detected in the step (a), automatically moving the reagent strip to a reagent strip inspection location; (c) illuminating the reagent strip when the reagent strip is at the reagent strip inspection location; (d) detecting light received from the reagent strip when the reagent strip is being illuminated in the reagent strip inspection position and generating illumination signals therefrom; and (e) storing signals relating to the illumination signals in a memory.
Step (a) may include the steps of: (a1) illuminating a first portion of the reagent strip receiving area at a first time; (a2) detecting light received from the first portion of the reagent strip receiving area while the first portion of the reagent strip receiving area is illuminated during the step (a1); (a3) illuminating a second portion of the reagent strip receiving area at a second time; and (a4) detecting light received from the second portion of the reagent strip receiving area while the second portion of the reagent strip receiving area is illuminated during the step (a3).
Step (a) may also include the steps of: (a1) illuminating a portion of the reagent strip receiving area; (a2) detecting light from the portion of the reag
Hough David
Howard, III Willis E.
Hurtle Richard
Rehm Gary E.
Bayer Corporation
Bex Kathryn
Coe Roger N.
Jeffers Jerome L.
Warden Jill
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