Chemistry: analytical and immunological testing – Automated chemical analysis – With sample on test slide
Reexamination Certificate
1998-10-13
2001-01-30
Snay, Jeffrey (Department: 1743)
Chemistry: analytical and immunological testing
Automated chemical analysis
With sample on test slide
C436S047000, C436S169000, C422S065000, C422S082050
Reexamination Certificate
active
06180409
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 having multiple readheads and a method for analyzing a reagent strip using multiple readheads.
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 of 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.
U.S. Pat. No. 4,689,202 to Khoja, et al. discloses a reagent test strip reading instrument having a pair of readheads adapted to optically inspect reagent strips and a conveyor system that transports reagent strips to the readheads. In the Khoja, et al. system, the readheads are adapted to read different, predetermined portions of a reagent strip. In particular, as described in column 11, lines 15-21 of the Khoja, patent, the fiber optics for reading the seven test areas on a reagent strip having a shorter incubation time are mounted on readhead 124 in position for alignment with such areas, and the fiber optics for reading the reagent test areas having the relatively longer incubation time are mounted on the readhead 125 in position for alignment with those areas.
SUMMARY OF THE INVENTION
In one aspect, the invention is directed to an apparatus for inspecting a reagent strip after the reagent strip has been contacted with fluid sample which is provided with a conveyor system adapted to move the reagent strip from a first reagent strip inspection location to a second reagent strip inspection location, a first readhead associated with the first reagent strip inspection location and adapted to optically inspect a plurality of reagent pads of the reagent strip, and a second readhead associated with the second reagent strip inspection location and adapted to optically inspect a plurality of reagent pads of the reagent strip, including at least one of the reagent pads that was optically inspected by the first readhead. Each of the readheads has a light source and a light detector associated therewith, each light source being adapted to illuminate the reagent strip at one of the reagent strip inspection locations and each light detector being adapted to detect light from the reagent strip when the reagent strip is disposed at one of the reagent strip inspection locations.
In another aspect, the invention is directed to an apparatus for inspecting reagent strips, each of which has a plurality of reagent pads disposed along its length and a body fluid sample disposed thereon. The apparatus includes a conveyor system adapted to move a plurality of the reagent strips to a first reagent strip inspection location and a plurality of the reagent strips to a second reagent strip inspection location, a first readhead associated with the first reagent strip inspection location, a second readhead associated with the second reagent strip inspection location, and a readhead positioning system operatively coupled to the first and second readheads. The readhead positioning system is adapted to selectively position the first readhead so that the first readhead inspects a plurality of the reagent pads disposed on the first reagent strip when the first reagent strip is disposed at the first inspection location, and the readhead positioning system is adapted to selectively position the second readhead so that the second readhead inspects a plurality of the reagent pads disposed on the second reagent strip when the second reagent strip is disposed at the second inspection location.
The invention is also directed to a method of automatically processing a reagent strip having a body fluid sample disposed thereon which includes the following steps: (a) automatically moving the reagent strip to a first reagent strip inspection location; (b) positioning a first readhead relative to the reagent strip when the reagent strip is at the first inspection location; (c) detecting light received from the reagent strip while the reagent strip is being illuminated at the first inspection location; (d) storing signals relating to the amount of light detected from the reagent strip when the reagent strip was positioned at the first inspection location in a memory; (e) automatically moving the reagent strip to a second reagent strip inspection location; (f) positioning a second readhead relative to the reagent strip when the reagent strip is at the second inspection location; (g) detecting light received from the reagent strip while the reagent strip is being illuminated at the second inspection location; and (h) storing signals relating to the amount of light detected from the reagent strip when the reagent strip was positioned at the second inspection location in a memory.
Where the reagent strip is provided with a plurality of reagent pads disposed along its length, step (b) may include the step of successively positioning the first readhead over a plurality of the reagent pads of the reagent strip, step (c) may include the step of detecting light received from a plurality of the reagent pads of the reagent strip while the reagent strip is being illuminated at the first inspection location, and step (d) may include the step of storing signals relating to the amount of light detected from the plurality of reagent pads of the reagent strip when the reagent strip was positioned at the first inspection location in a memory.
The features and advantages of the present invention will be apparent to those of ordinary skill in the art in view of the detailed description of the preferred embodiment, which is made with reference to the drawings, a brief description of which is provided below.
REFERENCES:
patent: 3907503 (1975-09-01), Betts et al.
patent: 4689202 (1987-08-01), Khoja et al.
patent: 4755058 (1988-07-01), Shaffer
patent: 4820491 (1989-04-01), Khoja et al.
patent: 5028139 (1991-07-01), Kramer et al.
patent: 5055261 (1991-10-01), Khoja et al.
patent: 5059394 (1991-10-01), Phillips et al.
patent: 5165078 (1992-11-01), Hough et al.
patent: 5231576 (1993-07-01), Suzuki et al.
patent: 5246858 (1993-09-01), Arbuckle et al.
patent: 5250262 (1993-10-01), Heidt et al.
patent: 5272518 (1993-12-01), Vincent
patent: 5661563 (1997-08-01), Howard et al.
patent: 5701181 (1997-12-01), Boiarski et al.
patent: 6027692 (2000-02-01), Galen et al.
Clinitek 50 User's Guide, 1996 Bayer Corporation, 30 pages, Mar. 1996.
W. E. Howard, III, “An Introduction To Reflectance Spectroscopy For Dry Phase Reagent Chemistry”, Miles Science Journal, pp. 33-37.
Howard, III Willis E.
Rehm Gary E.
Shaffer Gerald H.
Bayer Corporation
Jeffers Jerome L.
Snay Jeffrey
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