CA1218000A - Reagent test device holder - Google Patents

Reagent test device holder

Info

Publication number
CA1218000A
CA1218000A CA000454216A CA454216A CA1218000A CA 1218000 A CA1218000 A CA 1218000A CA 000454216 A CA000454216 A CA 000454216A CA 454216 A CA454216 A CA 454216A CA 1218000 A CA1218000 A CA 1218000A
Authority
CA
Canada
Prior art keywords
reagent
reagent test
pads
test devices
top member
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000454216A
Other languages
French (fr)
Inventor
David L. Boger
Jerry T. Pugh
Jack L. Zuidema
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Corp
Original Assignee
Miles Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Miles Laboratories Inc filed Critical Miles Laboratories Inc
Application granted granted Critical
Publication of CA1218000A publication Critical patent/CA1218000A/en
Expired legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5085Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • G01N31/22Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/805Test papers

Abstract

ABSTRACT OF THE DISCLOSURE

Apparatus is disclosed for accurately positioning and retaining multiple, individual reagent test devices in a holder. The holder consists of a base member and a top member in which the top member con-tains openings of at least the same number and dimen-sion as the reagent pads appearing on the test de-vices. The holder permits the practical utilization of multiple, individual dip-and-read test devices in automated instrumentation.

Description

REAGENT TEST DEVICE HOLDER

ACKGROU D OF THE_INVENTION
Field Of The Invention _ The present lnvention relates to apparatus for a.ccurately positioning and transporting multiple immunochemical, diagnostic or serological test devices and, more particularly, to such apparatus which fa-cilitates automated processing of the test devices.
The art of analytical chemistry has been greatly advanced since biochemistry began emerging as a pri-mary scientific rontier, requiring increasingly sophisticated analytical methods and tools to solve problems. Likewise the medical profession has lent impetus to the growth of analytical chemistry, with its desiderata of both high precision and speed in obtaining results.
To satisfy the needs of the medical profession as well as other expanding ~echnologies, such as the brewing industry, chemical manufacturing, etc., a 20 myriad of analytical procedures, composi~ions and apparatus have evolved, including ~he so called "dip-and-read" ~ype reagent test devices. Reagent test devices enjoy wide use in many analytical applica-tions, especially in the chemical analysis or bio-logical fluids, because of their relatively low cost,ease of usability, and speed in obtaining results. In medicine, for example, numerous physiological func-tions can be monitored merely by dipping a reagent test device into a sample of body f]uid, such as l~rine or blood, and observing a detectable response, such as a change in color or a change in the amount of light reflected from or absorbed by the test device.
Many of the "dip-and-read" test devices for de-tecting body fluid components are capable of making quantitative or at least semiquantitative meas-ure-ments. Thus, by measuring the response after a pre-determined time, an analyst can obtain not only a positive indication of the presence of a particular constituent in a test sample, but also an estimate of how much of the ronstitutent is present. Such tes-t devices provide the physician with a facile diagnostic tool as well as the ability to gage the extent of disease or of bodily malfunction.
Illustrative of such test devices currently in use are products available from the Ames Division of Miles Laboratories, Inc. under the -trademarks CLINI-STIX, MULTISTIX, KETOSTIX, N-MULTISTIX, DIASTIX, DEXTROSTIX, and others. Immunochemical, diagnostic or serological test devlces such as these usually com-prise one or more carrier matrices, such as absorbent paper, having incorporated therein a particular reagent or reactant system which manifests a detect-able response, e.g., a color change in the presence of a speciic test sample component or constituent.
Depending on the reactant system incorporated with a particular matrix, these test devices can detect the presence of glucose, ketone bodies, bilirubin, uro-bilinogen, occult blood, nitrite, and other substances.
A specific change in the intensity of color observed within a specific time range after contacting the test device with a sample is indicative of the presence of a particular constituent and/or its concentration in the sample. Some of these test devices and their reagent systems are set forth in U.S. Patent Mos.
3,123,443; 3,2l2,855; 3,8l4,668; etc.
Regardless of whether the test devic~ is used -Eor 5 the deter~ination of a biological fluid or the anal-ysis of a commercial or industrial fluid, the normal procedure requires that each test device separately come in contact with the sample or specimen to be tested and then th2t the test device be visually or lO instrumentally analyzed. Means has been sought in the art for accurately positioning and retaining multiple individual test devices for automated processing.
Prior to the presen-t invention no known system had the capability of achieving the desiderata mentioned above 15 in which mul.tiple, individual test devices could be retaîned in apparatus for automatic processing without a change in format of the test device.

Description Of The Prior Art _ The traditional dip~and-read test device can be 20 manufactured at relatively low cost and it is conven-ient for an individual to use, but it is not well suited for use with highly automated equipment. For automated equipment to be of any advantage, it must result in a benefit with respect to cost, handling, 25 and/or speed of obtaining information. Apparatus currently available for instrumentally reading indi-vidual reagent strips, such as the SERALYZER reflec-tance photometer or the CLINITEK reflectance pho-tometer, manufactured and sold by the Ames Division of 30 Miles Laboratories, Inc., Elkhart, Indiana, requires that each reagent test device must be manually loaded into the instrument after contacting the test device with specimen or sample to be ~ested. Manual loading requires that the reagent test device be properly 35 positioned in the lnstrument within a limited period ~8~

. l~ .
of time aEter contacting the solution or substance to be tested. At the end o~ the analysis, each test device must be removed from the instrument for dis-posal.
A different format is presently used in the CLINILAB automated urinalysis system, which is manu-factured and solcl by the Ames Divlsion of Miles Laboratories, Inc., Elkhart, Indiana. The CLINII.AB
instrumen~ uses a cassette containing reagent areas 10 mounted seriatim on a continuous plastic substrate which is wound into a reel and housed in a cassette.
While the CLINILAB reagent cassette is well suited for automation, the manufacturing cost for this type of format amounts to eight times that of the conventional 15 dip-and-read tes~ device format mentioned above.
In accordance with the present invention instru-mental testing for immunochemical, diagnostic or serological purposes can be achieved using multiple conventional dip-and-read type reagent test devices.
20 The apparatus results in an efficient, economical, rapid and convenient way of performing such analyses.

SU~ARY OF THE INVENTION

~ object of the present invention is to provide a rigid holder for multiple reagent test devices.
Another object of the present invention is to provide a holder for multiple reagent test devices which permits the accurate positioning and transport-ing of such test devices in automated equipment.
Still another object of the present invention is 30 to provide apparatus for conducting immunochemical, diagnostic or serological tests employ-ing multiple, conventional, low cost, vi.sual, dip-and-read reagent test devices.

In accordance with the present invention a holder Eor reagenL test devices is provided hav:ing a base member and a top mernber which permlt multiple indi-vidual reagent test devices ~o be accurately positioned parallel to one another, sald top member having open-5 ings exposing each reagent area on the ~est devicesfor the application of specimen or sample to be tested and the taking of reflec~ance measurements.

~RIEF DESCR:[PTIO OF TtlE DP~WINGS

Other and further objects, advantages and features 10 of the lnvention will be apparent to those skilled in the art from the following detailed description there of, taken in conjunction with the accompanying draw-ings, in which:
Fig. 1 is a top view of apparatus in accordance 15 with the present invention, said apparatus being open to receive individual reagent test devices;
Fig. 2 is a perspective view of the apparatus of Fig. 1 in which multiple -reagent test devices have been inserted, the top member being closed following 2Q the insertion of the test devices; and Fig. 3 is a perspective view of another embodi-ment of the invention designed to hold multiple, single pad reagent test devices.

DESCRIPTION OF THE PREFERRED EMBODIMENTS
_ _ The apparatus forming the subject ma~ter of the present inven~ion i5 characterized by a base member and top member which are or can be interconnected in such a manner to permit the insertion of multiple, individual reagent test devices into the apparatus such that ~he test devices are aligned parallel to ~ 6 -each other. I~hen the top member is (~losed reagent pads on the reagent te~t devlces are exposed through operlings in the top member corresponding to the loca-tion and dimension oE the reagent pads on each test 5 device. While the top member and base member are preferably permanently interconnected by hinge means in a fashion whi.ch permits the apparatus to be opened and closed, the base member and top member can, if desired, constitute separate members which become 10 engaged in suitable fashion once multiple test devices have been placed onto or inserted into the base member.
Turning now to Fig. 1 of the drawings, reagent test device holder 10 of the present invention is 15 sho~l in an open positlon with base member 12 and top member 14 interconnected by means of flexible plastic interconnecting member 16~ The design of the appara-tus permits the entire assembly to be molded at one time. By having the top member permanently inter-20 connected to base member 12 there is also the ad-vantage that the top member cannot be misplaced or lost when the apparatus is opened.
Reagent test device holder 10 can be constructed of any suitable material such as polyethylene, poly-25 propylene, ethylene copolymer, polystyrene, phenolicpolym~r, polycarbonate, acrylonitrile-butadiene-styrene copolymer, ~tc. Obviously, -the material should be chosen to be durable, readily cleanable and rel~tively inexpensive. Aluminum or some other suitable metal 30 could also be used for this purpose although metal holders tend to be somewhat more expensive than plastic holders. Another material which could be used, although less preferable, is cardboard which has been especially treated by a suitable coating to make it 35 water impermeable.

Base member 12 can have suitable ridges or other means which facilitate proper alignment of reagent test devices to assure that they become precisely parallel to one another. Top rnelrlber 14, on the other 5 hand, is constructed to have openings 18-18 which are of the same number and the same configuration as the reagent pads appearing on each reagent test device placed in base member 12. ~lile the openings in the top member of the holder are preferably of the same lO configuration as the reagent pads on the reagent test device ! these openings can be of any suitable con-figuration and, if desired, can be circular rather than square or rec-tangular. Top member 14 is designed to interconnect with base member 12 such that after 15 multiple reagent test devices have been inserted into holder 10 the top member can be connected with the base member to achieve perfect registry between the openings 18-18 in top member 14 and the reagent pads on the reagent test devices 20-20, as shown in Fig. 2.
Wnlile the holders of the present invention can be made inexpensively such that the entire holder is disposable, the design of the holder apparatus facili-tates the ready removal of used test devices and the reutilization of the reagent holder. Normally, all that is required in order to recondition a reagent holder device for reuse is simply removing any excess fluid by suitable blotting or through the use of controlled airflow. If desired, however, the reagent holders can be thoroughly cle~ned after each use.
While the illustrated reagent holders are more or less rectangular in configuration, other suitable con-figurations can be used if desired. For example, cir-cular holders could be employed with the reagent test devices radia-ting ou-t from the center of the circular holder. The preferred rectangular configuration, how-ever, pennits the maximum number of reagent test q~

devices to be inserted into a holder of the smallest possible dimensions.
As prevlously indicated, base mernber 12 cmd top member 14 can be interconnected by means 16. It will 5 be u~derstood, however, that any suitable means of permanently or ternporarily l.nterconnecting base member 12 and top member 14 can be used. Yor example, suitable hinges include a piano type hinge or any other suitable connecting hinge. Alternatively, base 10 member 12 and top member 14 can be entirely separate, becoming interconnected when the two pieces are brought (snapped) together such that the members are aligned in a particular manner in registry with the reagent matrices of the test devices which have been 15 inserted between the base member and the top member.
While Figs. 1 and 2 illustrate top member 14 containing ten openings 18-18 for each reagent test device, the number of openings can be varied depending upon a number of reagent pads present on the reagent 20 test devices employed. In Fig. 3, for example, a holder for single pad reagent test devices is shown in which the top member of the holder contains a single opening ~2-22 for each reagent test device.
Whereas Figs. 2 and 3 illustrate the handle por-25 tion of the reagent test devices extending beyond theholder J it should be understood that the reagent holder can be made long enough to accommodate the entire reagent test device.
Once the reagent test devices have been inserted 30 into the holder the reagent pads, which are exposed by the openings in the top member of the reagent holder, can be contacted with sample ~o be tested by any suitable means. For example, the entire holder can be dipped into the sample to be tested. Preferably, 35 however, th~ sample to be tested is applied to the pads by convenient means such as placing one or more drops of the sample to be tested directly on each reagent pad. The latter procedure, c~bviously, can be automated using multiple d:ispenser tlps interconnected to a common reservolr cvntaining sarnple to be tested.
Because of the configura~ion of the holder apparatus, multiple test devices can be preloaded into eaeh holder and individual or multiple holders fed into automated photometric apparatus for determining reflectance charac~eristics of treated reagent pads.
From ~he foregoing, it will be seen that this invention is well adapted to attain all of the ends and objects hereinabove set forth, together with other advantages which are obvious and which are inherent to the system. The apparatus of the present invention 15 has the advantages of convenience, simplicity, re-latively inexpensiveness, positiveness, effectiveness3 durability, accuracy and directness of action. The invention substantially overcomes the pro'blem of having to use different formats in order to facilitate inexpensive, rapid, immunochemical, diagnostic or serological testing. Conventional, low cos-t, visual type dip-and-read test devices can 'be used. There is no need to adopt a different or more expensive format.
The holder apparatus oE the present invention provides a very effective way of accurately positioning and transporting such test devices in automated instru-ments. Moreover, the openings in the top of the holder, t'hrough which the reagent pads are exposed, help prevent runover from occurring between adjacent 30 reagent pads on the test devices. Runover can be a serious concern, particul.arly when incompatible reagents are present. Of course, the holder permits rapid and accurate alignment of all of -the reagent pads in automated instrumellts upon alignment of the reagent holder.

Another advanl~age of ~he reagent holder :is that the holder protects the reagent pads prior to use.
This is a significant aclvantage in that occasionally one or more of the reagent pad areas on a reagent test device can become damaged during handling prior to or in the process of using the -test device duc to the fact that the reagent pad areas e~tend upward and are exposed on the surface of the test device substrate.
Another advantage of the reagent holder is that it facilikates contact oE the reagent test devices with sample material and the presentation of the sample contacted t~st device to an instrument for performing a reflectance measurement thereby elimi-nating wasted test devices which sometimes occur with inexperienced users who have not developed a good technique for contacting specimen to be tested with the reagent test device.
Should there be a desire to store test devices for any period of time after testing, the holder of the present invention permits a convenient way of storing and retalning such test d~vices.
Obviously, many other modifications and varia-tions of the invention as hereinbefore set forth can be made without departing from the spirit and scope thereof.

:'

Claims (6)

The embodiments of the invention in which an ex-clusive property or privilege is claimed are defined as follows:
1. Apparatus for simultaneously making multiple analyses of liquid fluid, which apparatus comprises in combination:
multiple, separate, dip-and-read reagent test devices, each consisting essentially of one carrier matrix pad, having reagent incorpor-ated therein, attached to the upper surface of one end of an elongated, flexible sub-strate, wherein each said carrier matrix pad is raised to a height substantially above the surface of the substrate to which said matrix pad is attached; and reagent test device holding means for accurately positioning and retaining said carrier mat-rix pads of the reagent test devices immo-bile during analyses, said reagent test hol-ding means consisting essentially of a base member for retaining said reagent test de-vices in parallel alignment, a separate top member containing openings substantially identical in size, number and configuration to the carrier matrix pads, hinge means for interconnecting the base member and the top member wherein the openings of said top mem-ber are in registry with each carrier matrix pad of said reagent test devices such that the reagent pads project into said openings so as to immobilize and isolate each carrier matrix pad during the analysis of a liquid fluid and substantially eliminate runover from occurring between adjacent carrier ma-trix pads on the reagent test devices, where-in said reagent test device holding means is constructed of a rigid, cleanable material of thickness such that the openings in said top member form wells into which liquid fluid to be analyzed is placed.
2. The apparatus of claim 1 in which the rea-gent test device holding means is plastic.
3. The apparatus of claim 1 in which the means for interconnecting the base member and top member of said reagent test holding means is a piano hinge.
4. Apparatus for simultaneously making multiple analyses of liquid fluid, which apparatus comprises in combination:
multiple, separate, dip-and-read reagent test devices, each consisting essentially of a plurality of carrier matrix pads having re-agent incorporated therein, attached to the upper surface of an elongated, flexible sub-strate in a horizontally spaced manner, wherein each said carrier matrix pad is raised to a height substantially above the surface of the substrate to which said mat-rix pad is attached; and reagent test device holding means for accurately positioning and retaining said carrier mat-rix pads of the reagent test devices immo-bile during analyses, said reagent test hol-ding means consisting essentially of a base member for retaining said reagent test de-vices in parallel alignment, a separate top member containing openings substantially identical in size, number and configuration to the carrier matrix pads, hinge means for interconnecting the base member and the top member wherein the openings of said top mem-ber are in registry with each carrier mat-rix pad of said reagent test devices such that the reagent pads project into said openings so as to immobilize and isolate each carrier matrix pad during the analy-sis of a liquid fluid and substantially eliminate runover from occurring between adjacent carrier matrix pads on the rea-gent test devices, wherein said reagent test device holding means is constructed of a rigid, cleanable material of thick-ness such that the openings in said top member form wells into which liquid fluid to be analyzed is placed.
5. The apparatus of claim 4 in which the rea-gent test device holding means is plastic.
6. The apparatus of claim 4 in which the means for interconnecting the base member and top member of said reagent test holding means is a piano hinge.
CA000454216A 1983-06-06 1984-05-14 Reagent test device holder Expired CA1218000A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/501,609 US4518565A (en) 1983-06-06 1983-06-06 Reagent test device holder
US501,609 1983-06-06

Publications (1)

Publication Number Publication Date
CA1218000A true CA1218000A (en) 1987-02-17

Family

ID=23994275

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000454216A Expired CA1218000A (en) 1983-06-06 1984-05-14 Reagent test device holder

Country Status (5)

Country Link
US (1) US4518565A (en)
EP (1) EP0128422B1 (en)
JP (1) JPS59228943A (en)
CA (1) CA1218000A (en)
DE (1) DE3476274D1 (en)

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Also Published As

Publication number Publication date
EP0128422A2 (en) 1984-12-19
EP0128422B1 (en) 1989-01-18
JPS6156021B2 (en) 1986-12-01
EP0128422A3 (en) 1986-02-05
US4518565A (en) 1985-05-21
JPS59228943A (en) 1984-12-22
DE3476274D1 (en) 1989-02-23

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