Field of the Invention

This invention relates to assay devices and assay apparatus.

Background of the Invention

Assays are part of multiple step investigative procedures for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of one or more specimens. Assays include pre- and post-analytic procedures. Pre- analytic steps include inter alia information processing, specimen handling, and the like. Post-analytic steps include inter alia report documentation, report transmission, and the like. Assays can be employed for investigating chemical specimens, biological specimens, organic specimens and non-organic specimens. Specimens can be solid, liquid, gel, and the like. Investigations can include inter alia ElectroMagnetic Radiation (EMR) examinations at one or more predetermined EMR spectrum including inter alia visual spectrum, IR spectrum, UV spectrum, and the like. Such EMR examinations include inter alia naked eye visual examinations, optical examinations using optical apparatus, for example, microscopes, and the like, and digital scanning for image processing purposes.

Summary of the Invention

Generally speaking, the present invention is directed towards assay devices for use with a handheld specimen handling tool including inter alia a syringe, a pipette, a specimen sampling device, and the like. The specimen handling tool has a leading specimen sample collection end which can take different forms depending on a specimen to be sampled. Suitable specimen sampling collection ends include inter alia a brush, a swab, a shallow bowl, a needle, and the like. The assay devices are designed to be equivalent to a conventional arrangement of a cover slip for placing on a specimen placed on a microscope slide for investigation purposes. The assay devices include a housing having a specimen slide elevation arrangement for elevating a specimen slide from an initial lowermost specimen introduction position to a final uppermost specimen examination position correspondingly remote from and adjacent a housing top face. The housing top face, the specimen slide and a housing bottom face opposite the housing top face each have a panel in mutual registration defining a line of examination therethrough. The panels are transparent to at least one predetermined EMR spectrum. The housing top face panel and the specimen slide panel bound a compression zone therebetween. A handheld specimen handling tool is employed for placing a specimen on the specimen slide panel in its initial lowermost specimen introduction position. The specimen slide elevation arrangement is deployed for elevating the specimen slide to intimately juxtapose its specimen slide panel against the housing top face panel for compressing the specimen therebetween in a similar manner to a conventional arrangement of a microscope slide and a cover slip. The handheld specimen sampling device is necessarily removed from the compression zone during the elevation of the specimen slide.

Brief Description of Drawings

In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:

Fig. 1 is a front perspective view of a first preferred embodiment of an assay device with a specimen slide in an initial lowermost specimen introduction position and a handheld specimen handling tool having a specimen;

Fig. 2 is a front perspective view of the Figure 1 assay device with the specimen slide in a final uppermost specimen examination position for naked eye visual examination of the specimen;

Fig. 3 is an exploded view of the Figure 1 assay device; Fig. 4 is a longitudinal cross section of the Figure 1 assay device after placing the specimen on the specimen slide along line 4-4 in Figure 1 ;

Fig. 5 is a longitudinal cross section of the Figure 1 assay device along line 5-5 in Figure 2;

Fig. 6 is a front perspective view of a second preferred embodiment of an assay device with a specimen slide in an initial lowermost specimen introduction position;

Fig. 7 is a front perspective view of the Figure 6 assay device with the specimen slide in a final uppermost specimen examination position for IR imaging of the specimen;

Fig. 8 is an exploded view of the Figure 6 assay device;

Fig. 9 is a longitudinal cross section of the Figure 6 assay device along line 9-9 in Figure 6;

Fig. 10 is a longitudinal cross section of the Figure 6 assay device along line 10-10 in Figure 7;

Fig. 11 is a front perspective view of a third preferred embodiment of an assay device with a specimen slide in an initial lowermost specimen introduction position and a pre-deployed handheld pull through elongated swab having a specimen;

Fig. 12 is an exploded view of the Figure 11 assay device;

Fig. 13 is a front elevation view of the Figure 11 assay device's housing; Fig. 14 is a front perspective view of the Figure 1 1 assay device's specimen slide;

Fig. 15 is a partially exploded view of the Figure 11 assay device with the specimen slide in the initial lowermost specimen examination position;

Fig. 16 is a front perspective view of the Figure 11 assay device with the specimen slide in a final uppermost specimen examination position for naked eye visual examination; Fig. 17A is a transverse cross section of the Figure 11 assay device along line 17 A- 17 A in Figure 11;

Fig. 17B is a partial cut-away view of the Figure 11 assay device with the specimen slide in its initial lowermost specimen introduction position along line 17B-17B in Figure 11;

Fig. 17C is a transverse cross section of the Figure 11 assay device along line 17C-17C in Figure 16;

Fig. 17D is a partial cut-away view of the Figure 11 assay device with the specimen slide in its final uppermost specimen examination position along line 17D-17D in Figure 16;

Fig. 18 is a front perspective view of a fourth preferred embodiment of an assay device for use with assay apparatus;

Fig. 19 is a close-up view of a specimen slide elevation member of the Figure 18 assay apparatus;

Fig. 20 is a longitudinal cross section of the Figure 18 assay device mounted on the specimen slide elevation member along line 20-20 in Figure 19; and

Fig. 21 is a perspective view of the assay apparatus with the Figure 18 assay device inserted for specimen examination. Detailed Description of Drawings

Figure 1 to Figure 5 show an assay device 10A for use with a handheld specimen handling tool 100 in the form of a spoon with a leading specimen collection end 101 in the form of a shallow bowl. The bowl 101 contains a specimen S. The assay device 10A affords a line of examination 11 therethrough for examination of a specimen inserted thereinto.

The assay device 10A includes a dual component cylindrical housing 12 having a base 13 and a cover 14. The base 13 constitutes a housing bottom face 16 and a housing peripheral face 17. The cover 14 constitutes a housing top face 18 opposite the housing bottom face 16. The housing peripheral face 17 is formed with a specimen introduction port 19 for enabling introduction of a specimen into the housing 12.

The assay device 10 A includes a specimen slide 21 below the specimen introduction port 19 in an initial lowermost specimen introduction position (see Figure 1 and Figure 4). The housing bottom face 16 has a transparent housing bottom face panel 22, the housing top face 18 has a transparent housing top face panel 23 and the specimen slide 21 has a transparent specimen slide panel 24 in mutual registration for enabling the line of examination 11. The housing top face panel 23 and the specimen slide panel 24 define a compression zone therebetween. The panels 22, 23 and 24 are transparent to the visible spectrum for naked eye examination through the assay device 10A along the line of examination 11. The specimen can be additionally backlighted from a visible light source 150 under the assay device 10A.

The assay device 10A includes a specimen slide elevation arrangement 26 for elevating the specimen slide 21 from its initial lowermost specimen introduction position (see Figure 1 and Figure 4) to a final uppermost specimen examination position (see Figure 2 and Figure 5) correspondingly remote from and adjacent the housing top face 18. The specimen slide elevation arrangement 26 is constituted by a manually operated specimen slide elevation mechanism in the form of the specimen slide 21 having a diametric pair of outward radial specimen slide elevation members 27 extending through a diametric pair of elevation tracks 28 formed in the housing peripheral face 17. The diametric pair of elevation tracks 28 each spiral from a lowermost elevation track end 29 adjacent the housing bottom face 16 to an uppermost elevation track end 31 adjacent the housing top face 18. The elevation tracks 28 are preferably about a quarter turn in length.

Deployment of the diametric pair of specimen slide elevation members 27 at the lowermost elevation track ends 29 corresponds to the initial lowermost specimen introduction position. Deployment of the diametric pair of specimen slide elevation members 27 at the uppermost elevation track ends 31 corresponds to the final uppermost specimen examination position. The specimen slide elevation arrangement 26 enables a user to impart a rotation movement of the specimen slide 21 relative to the housing 12 for elevating the specimen slide 21 from its initial lowermost specimen introduction position to its final uppermost specimen examination position.

In the final uppermost specimen examination position, the transparent specimen slide panel 24 is intimately juxtaposed against the transparent housing top face panel 23 for compressing the specimen S therebetween. Compression of a specimen thinly spreads the specimen similar to a conventional arrangement of a cover slip on a microscope slide. Assay devices 10A can be designed for applying different degrees of compression of different specimens. The housing bottom face 16 can be lined with hygroscopic material 32 to absorb liquid residues displaced from the specimen slide 21 pursuant to its elevation to its final uppermost specimen examination position. The liquid residues can include specimen residues and reagent residues in the case of dispensing a liquid reagent on a specimen for reacting with same. The specimen slide 21 is preferably provided with an annular arrangement of drainage holes 21 A for facilitating drainage from the specimen slide panel 24 to the hygroscopic material 32.

The use of the assay device 10A is as follows: A user uses the handheld specimen handling tool 100 to collect a specimen S. The user introduces the specimen S into the housing 12 and deposits at least some of the specimen S on the specimen slide panel 24. The user withdraws the specimen handling tool 100 from the compression zone in order not to obstruct elevation of the specimen slide 21. The user can optionally introduce a liquid reagent dispenser through the specimen introduction port 19 for dispensing liquid reagent on the specimen for reacting with same or diluting same.

The user grips the housing 12 in one hand and uses his other hand to impart a rotation movement of the specimen slide 21 relative to the housing 12 for elevating the specimen slide 21 from its initial lowermost specimen introduction position to its final uppermost specimen examination position for compressing the specimen S against the housing top face panel 23. The user can view the specimen S through the housing top face panel 23 for visual examination of same. The user can place the assay device 10A on a visible light illumination source 150 for backlighting the specimen S for assisting visual examination. Alternatively, the user can place the assay device 10A on a microscope in a similar manner as a conventional microscope slide for optical examination of the specimen S.

Figure 6 to Figure 10 show an assay device 10B similar in construction to the assay device 10A and therefore similar parts are likewise numbered. The assay device 10B differs from the assay device 10A in three respects as follows: First, the specimen slide elevation arrangement 26. Second, the assay device 10B is intended for IR examination of a specimen and not naked eye visual examination. Accordingly, the assay device 10B can be opaque to the naked eye. And third, the assay device 10B can have different shapes including inter alia square, rectangle, ellipsoidal, and the like.

The assay device 10B has a specimen slide elevation arrangement 26 constituted by a specimen slide elevation actuator 33 deployed under the specimen slide 21 in its initial lowermost specimen introduction position. The specimen slide elevation actuator 33 has an initial set-up position and a final examination position respectively corresponding to the specimen slide's initial lowermost specimen introduction position (see Figure 6 and Figure 9) and a final examination position corresponding to specimen slide's final uppermost specimen examination position (see Figure 7 and Figure 10). A user rotates the specimen slide elevation actuator 33 through a quarter clockwise turn A from its initial set-up position to its final examination position.

The use of the assay device 10B is similar to the assay device 10A except that a user rotates the specimen slide elevation actuator 33 rather than rotating the specimen slide 21 relative to the housing 12. The user places the assay device 10B between an IR radiation source 160 and an IR radiation detector 170. The IR radiation detector 170 detects IR radiation from the IR radiation source 160 which passes through the assay device 10B and its specimen along the line of examination 11.

Figure 11 to Figure 17 show an assay device IOC similar in construction to the assay device 10A and therefore similar parts are likewise numbered. The assay device IOC is supplied with a pre-deployed handheld specimen handling tool 100 in the form of an elongated pull through swab. The pull through swab 100 includes a shank 102, a leading swab head 103 and a trailing handle 104. The swab head 103 has a greater diameter than the shank 102 and is preferably intentionally detachable therefrom on application of a relatively small detachment force. Such detachment promotes safe handling of the assay device IOC by precluding contact with the swab head 103.

The assay device IOC includes a box like housing 12 having a longitudinal assay device centerline 34, a major front face 36, a major back face 37 opposite the major front face 36, a leading minor end face 38 and a trailing minor end face 39 opposite the leading minor end face 38. The leading minor end face 38 and the trailing minor end face 39 are correspondingly formed with a leading minor end face port 41 and a trailing minor end face port 42. The leading minor end face port 41 has a greater diameter than the swab head 103 such that the swab head 103 can be pulled into the assay device IOC. The trailing minor end face port 42 is formed with a pair of abutment members 43 defining an opening therebetween smaller than the swab head 103 such that the swab head 103 detaches from the shank 102 on abutment thereagainst on pulling the swab 100 through the assay device IOC. The swab 100 has an initial set-up position in the assay device IOC in which its swab head 103 is remote from the leading minor end face 38 and its handle 104 is adjacent the trailing minor end face 39. The swab head 103 can typically protrude by say 15 cm from the leading minor end face 38 in the initial set-up position.

The assay device IOC includes a specimen slide elevation arrangement 26 constituted by a leading specimen slide elevation actuator 44A adjacent the leading minor end face 38 and a trailing specimen slide elevation actuator 44B adjacent the trailing minor end face 39. The leading specimen slide elevation actuator 44 A extends widthwise across the housing 12 and protrudes from an opposite pair of specimen slide elevation tracks 46A in the major front face 36 and the major back face 37 for manual actuation purposes. The specimen slide elevation tracks 46 A each have a lower inclined elevation leg 47A and an upper horizontal locking leg 48 A adjacent the housing top face 18 and extending from its lower inclined elevation leg 47A towards the trailing minor end face 39. The trailing specimen slide elevation actuator 44B extends widthwise across the housing 12 and protrudes from an opposite pair of specimen slide elevation tracks 46B in the major front face 36 and the major back face 37 for manual actuation purposes. The specimen slide elevation tracks 46B each has an inclined elevation leg 47B and a horizontal locking leg 48B adjacent the housing top face 18 and extending from its lower inclined elevation leg 47B towards the leading minor end face 38. The inclined elevation legs 47A and the inclined elevation legs 47B converge towards one another from the housing bottom face 16 towards the housing top face 18 such that the specimen slide elevation actuators 44 A and 44B have an initial set-up position adjacent the housing bottom face 16 and a final examination position towards the housing top face 18. The initial set-up position corresponds to the initial lowermost specimen introduction position and the final examination position corresponds to the final uppermost specimen examination position.

The assay device IOC includes a specimen slide 21 having three discrete work surfaces as follows: a leading work surface 51 adjacent the leading minor end face 38, a central work surface 52 midway between the leading minor end face 38 and the trailing minor end face 39 and a trailing work surface 53 adjacent the trailing minor end face 39. The assay device IOC is designed such that the swab end 103 smears specimen on the work surfaces 51, 52 and 53 as the swab 100 is pulled from its initial set-up position through the assay device IOC to withdraw the shank 102 therefrom leaving the swab head 103 in the housing 12. The leading work surface 51 has a pH detection surface 54 for providing a visible color indication regarding the pH value of a specimen smeared thereon. The leading work surface 51 is not necessarily transparent as opposed to the central work surface 52 and the trailing work surface 53 are necessarily transparent to afford parallel lines of examination through the assay device IOC. The transparent housing top face panel 23 can extend lengthwise along the three work surfaces 51, 52, and 53 or alternatively be formed with individual sub-panels 23A and 23B each covering a single work surface.

The assay device IOC includes an integral liquid reagent pump arrangement 56 for pumping one or more liquid reagents for reacting with a corresponding number of specimen samples during elevation of the specimen slide 21 to its final uppermost specimen examination position. The liquid reagents may change color on reaction with the specimen samples or undergo another discernible change. The liquid reagent pump arrangement 56 includes a central liquid reagent reservoir 57 containing a liquid reagent X and a central plunger 58 for inserting in the central liquid reagent reservoir 57 for pumping liquid reagent X therefrom onto the specimen on the central work surface 52. The central liquid reagent reservoir 57 typically contains, for example, saline. The liquid reagent pump arrangement 56 includes a trailing liquid reagent reservoir 59 containing a liquid reagent Y and a trailing plunger 61 for inserting in the trailing liquid reagent reservoir 59 for pumping liquid reagent Y therefrom onto the specimen on the trailing work surface 53. The trailing liquid reagent reservoir 59 contains, for example, potassium hydroxide. The central liquid reagent reservoir 57 and the trailing liquid reagent reservoir 59 are formed on the specimen slide 21. The central plunger 58 and the trailing plunger 61 are downward depending from the housing top face 18 in the direction of the housing bottom face 16.

The central plunger 58 is provided with a central plunger groove 58A for pumping liquid reagent X from the central liquid reagent reservoir 57 onto the central work surface 52 as the specimen slide 21 is displaced from its initial lowermost specimen introduction position to its final uppermost specimen examination position. The trailing plunger 61 is similarly provided with a trailing plunger groove 61 A for pumping liquid reagent Y from the trailing liquid reagent reservoir 59 onto the trailing work surface 53 as the specimen slide 21 is displaced from its initial lowermost specimen introduction position to its final uppermost specimen examination position.

Figure 17A shows the central liquid reagent reservoir 57 filled with liquid reagent X and the central plunger 58 in its set-up position. Figure 17B shows the trailing liquid reagent reservoir 59 filled with liquid reagent Y and the trailing plunger 61 in its set-up position. Figure 17C shows elevation of the specimen slide 21 from its initial lowermost specimen introduction position to its final uppermost specimen examination position urges the central plunger 58 into the central liquid reagent reservoir 57 for dispensing liquid reagent X via the central plunger groove 58A on the specimen on the central work surface 52. Similarly, Figure 17D shows the trailing plunger 61 being urged into the trailing liquid reagent reservoir 59 for dispensing liquid reagent Y via the trailing plunger groove 61 A on the specimen on the trailing work surface 53.

The use of the assay device IOC is similar to the assay device 10A. A user collects specimen on the swab head 103 and pulls the swab 100 through the assay device IOC such that the swab head 103 passes through the leading minor end face port 41 before smearing specimen on the leading work surface 51, the central work surface 52 and the trailing work surface 53. The user continues to pull on the handle 104 such that the swab head 103 abuts against the abutment members 43 and detaches from the shank 102.

The pH detection surface 54 changes color in accordance with the specimen's pH and is visible through the housing top face panel 23. The user holds the housing 12 in one hand and uses his other hand's forefinger and thumb to displace the specimen slide elevation actuator 44A and the specimen slide elevation actuator 44B towards one another. Such displacement initially correspondingly pumps liquid reagents from the central liquid reagent reservoir 57 and the trailing liquid reagent reservoir 59 onto the central work surface 52 and trailing work surface 53 for reaction with specimen smeared thereon. Such displacement ends with the specimen slide panel 24 juxtaposed against the housing top face panel 23. Excess liquid reagent and specimen are drained from the central work surface 52 and the trailing work surface 53 onto the hygroscopic material 32 lining the housing bottom face 16. The user can visually examine the reacted specimens on the central work surface 52 and the trailing work surface 53 along their corresponding lines of examination 11 through the assay device IOC. Alternatively, the reacted specimens can be examined under non- visible EMR spectrum, and the like.

Figure 18 to Figure 21 show an assay device 10D similar in construction to the assay device IOC and therefore similar parts are likewise numbered. The assay device 10D is also supplied with a pre-deployed handheld specimen handling tool 100 in the form of an elongated pull through swab. The assay device 10D is intended to be used with assay apparatus 200 in the form of a digital microscope, and the like. Suitable digital microscopes include inter alia Leica DVM6, and the like. The assay apparatus 200 can be a standalone device with built-in diagnosis capabilities for examining a specimen. Alternatively, the assay apparatus 200 can transmit images and other information acquired from a specimen for remote processing.

The assay apparatus 200 includes an assay apparatus housing 201 and a reciprocal assay device tray 202. The assay apparatus 200 is preferably operative similar to a personal computer having a disc drive insofar as the assay device tray 202 has an assay device access position (see Figure 18) and an assay device examination position (see Figure 21). The assay device tray 202 protrudes further from the assay apparatus housing 201 in the assay device access position than the assay device examination position. The assay device tray 202 enables placement of an assay device 10D thereon in the assay device access position and removal therefrom. The assay device tray 202 is inserted in the assay apparatus housing 201 for specimen examination purposes. The assay device tray 202 includes a specimen slide elevation member 203 for insertion into an assay device 10D for elevating its specimen slide 21 from its initial lowermost specimen introduction position to its final uppermost specimen examination position. The specimen slide elevation member 203 is preferably forked shape with spaced apart specimen slide elevation prongs 204 which do not obstruct lines of examination 11 through the assay device 10D. The specimen slide elevation member 203 preferably includes a multi-pin connector 206 for connection to a matching assay device multi-pin connector.

The assay device 10D differs from the assay device IOC into three respects as follows: First, the assay device 10D does not include a manual operated specimen slide elevation arrangement. As an alternative for use with the assay apparatus 200 with the specimen slide elevation member 203, a discrete specimen slide elevation member 203 can be inserted in the assay device 10D for elevating its specimen slide 21 from its initial lowermost specimen introduction position to its final uppermost specimen examination position. Second, the assay device 10D requires manual introduction of liquid reagents instead of the liquid reagent pump arrangement. And third, the assay device 10D includes a commercially available so-called electrochemical nose for obtaining odor information from a specimen. Such electrochemical noses are also known as e-nose and micro nose. Commercially available electrochemical noses include inter alia Figaro TGS8100, and the like.

The leading minor end face 38 is formed with a slot pair 62 spaced apart across its width and under the specimen slide 21 in its initial lowermost specimen introduction position. The slot pair 62 is intended to slidingly receive the specimen slide elevation member 203 therein. The housing 12 is formed with a specimen slide guidance track 63 for guiding the specimen slide 21 from its initial lowermost specimen introduction position to its final uppermost specimen examination position on the sliding insertion of the specimen slide elevation member 203 thereinto. The assay device 10D includes a housing top face 18 with two liquid reagent ports 64 and 66 for introducing two liquid reagents for reacting with specimens on the central work surface 52 and the trailing work surface 53.

The assay device 10D includes an electrochemical nose 70 for obtaining odor information from the specimen S and a matching multi-pin connector 71 to the multi-pin connector 206. The multi-pin connectors 206 and 71 can include power lines for powering the electrochemical nose 70 and data lines for odor information regarding the specimen S.

The use of the assay device 10D is the same as the assay device IOC except that a user is required to manually add liquid reagent to the specimens on the central work surface 52 and trailing work surface 53. Also the user is required to mount the assay device 10D onto the assay device tray 202 ensuring correct insertion of the specimen slide elevation member 203 thereinto as opposed to actuating the specimen slide elevation actuators 44. On operation of the assay apparatus 200 to draw the assay tray 202 into the assay apparatus housing 201, the assay apparatus 200 examines the reacted specimens on the central work surface 52 and the trailing work surface 53 along their corresponding lines of examination 11 through the assay device 10D. Also, the assay apparatus 200 detects the specimen's pH value from the pH detection surface 54.

While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.