ASSAY SYSTEM INCLUDING ASSAY APPARATUS AND HANDHELD SINGLE USE ASSAY DEVICES FOR USE THEREWITH

• US 20200132703A1
• Filed: 12/23/2019
• Published: 04/30/2020
• Est. Priority Date: 06/21/2017
• Status: Active Grant

• Current Assignee: Gyntools Ltd.
• Original Assignee: Gyntools Ltd.
• Inventors: LEV-SAGIE, Menachem, LEV, Nimrod, SHLOMOVITZ, Tal, HOROWITZ LIMOR, Zohar
• Granted Patent: US 11,346,850 B2
• Time in Patent Office: Days
• CPC Class Codes: G01N 2035/00039 Transport arrangements specific to flat sample substrates, e.g. pusher blade
• CPC Class Codes: G01N 2035/00138 Slides
• CPC Class Codes: G01N 21/33 using ultraviolet light G01N21/39 takes precedence
• CPC Class Codes: G01N 21/35 using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 21/80 Indicating pH value
• CPC Class Codes: G01N 23/083 the radiation being X-rays
• CPC Class Codes: G01N 31/221 for investigating pH value
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00584 Control arrangements for automatic analysers
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: G01N 35/1081 characterised by the means for relatively moving the transfer device and the containers in an horizontal plane G01N35/1011 takes precedence

Abstract

Assay systems including assay apparatus and handheld assay devices for use therewith for obtaining diagnostic information of a bodily specimen. Assay devices include a cartridge housing snugly accommodating a specimen slide intended for elevation from an initial lowermost specimen introduction position to a final uppermost specimen examination position in which a bodily specimen is compressed between a cartridge housing top face and a specimen slide. Assay devices preferably include a liquid reagent dispensing arrangement for dispensing liquid reagent on a specimen slide for reacting with a bodily specimen.

Claims

1. An assay device for enabling ElectroMagnetic Radiation (EMR) examination of a bodily specimen at at least one predetermined EMR spectrum, the assay device having an upright assay device centerline and a horizontal longitudinal assay device centerline perpendicular to the upright assay device centerline, the assay device comprising:

(a) a cartridge housing having a cartridge housing top face, a cartridge housing bottom face opposite said cartridge housing top face, and a cartridge housing peripheral face between said cartridge housing top face and said cartridge housing bottom face to bound a cartridge housing interior,

said cartridge housing top face and said cartridge housing bottom face being transverse to the upright assay device centerline and said cartridge housing peripheral face being co-directional with the upright assay device centerline,

said cartridge housing having a specimen introduction port for enabling introduction of bodily specimen into said cartridge housing interior; and

(b) a specimen slide snugly accommodated in said cartridge housing interior and capable of sliding elevation from an initial lowermost specimen introduction position in an unused assay device to a final uppermost specimen examination position in an used assay device correspondingly remote from and adjacent said cartridge housing top face,

said specimen slide being intimately juxtaposed against said cartridge housing top face in said final uppermost specimen examination position for compressing at least some bodily specimen between said specimen slide and said cartridge housing top face subsequent to bodily specimen being deposited on said specimen slide in said initial lowermost specimen introduction position,

the assay device having a line of examination through said cartridge housing and said specimen slide wherein said line of examination is co-directional with the upright assay device centerline for enabling examination of said compressed at least some bodily specimen at the at least one predetermined EMR spectrum.

2. The device according to claim 1 wherein said specimen slide includes a pH chemical detector for providing a visible color indication regarding the bodily specimen'"'"'s pH value.

3. The device according to claim 1 wherein said specimen slide includes at least one visually discernible autofocus target for enabling autofocusing thereon in said final uppermost specimen examination position.

4. The device according to claim 1 wherein said cartridge housing includes at least one throughgoing aperture under said specimen slide in said initial lowermost specimen introduction position for sliding insertion of a specimen slide elevation member into said cartridge housing interior for elevating said specimen slide from said initial lowermost specimen introduction position to said final uppermost specimen examination position on said sliding insertion of the specimen slide elevation member into said cartridge housing interior.

5. The device according to claim 4 wherein said cartridge housing bottom face includes said at least one throughgoing aperture under said specimen slide.

6. The device according to claim 1 wherein said cartridge housing includes a built-in liquid reagent dispensing arrangement including a liquid reagent reservoir for dispensing liquid reagent on at least some bodily specimen on said specimen slide to react therewith before said sliding elevation of said specimen slide from said initial lowermost specimen introduction position to said final uppermost specimen examination position.

7. The device according to claim 6 wherein said cartridge housing includes a longitudinal directed barrel lateral to the horizontal longitudinal assay device centerline,

said barrel including an exposed leading seal, a trailing seal and liquid reagent between said exposed leading seal and said trailing seal,

said barrel having a liquid reagent dispensing port for dispensing liquid reagent on said specimen slide for reacting with bodily specimen deposited thereon,

said leading seal and said trailing seal having an initial pre-liquid dispensing position in an unused assay device and a final post-liquid dispensing position in an used assay device,

said trailing seal being urged past said liquid reagent dispensing port on being urged from said initial pre-liquid reagent dispensing position to said final post-liquid reagent dispensing position.

8. The device according to claim 7 wherein at least one of said leading seal and said trailing seal is highly visually distinguishable within said cartridge housing for enabling determination of its position along said barrel.

9. The device according to claim 6 wherein said cartridge housing top face includes a downward depending plunger for insertion into said built-in liquid reagent reservoir on said sliding elevation of said specimen slide from said initial lowermost specimen introduction position to said final uppermost specimen introduction position for dispensing liquid reagent onto said specimen slide.

10. The device according to claim 1 pre-assembled with a handheld specimen collection tool having a shank, a handle and a specimen collection tip for bearing a bodily specimen, the handheld specimen collection tool'"'"'s shank transversing said cartridge housing such that its specimen collection tip and handle oppositely extend beyond said cartridge housing peripheral face, and the handheld specimen collection tool'"'"'s handle includes a manual operated release button for mechanically engaging said cartridge housing peripheral face in a pre-assembled state before use thereby precluding relative movement of the handheld specimen collection tool relative to the assay device.

11. The device according to claim 10 wherein said cartridge housing top face includes guidance members downward depending into said cartridge housing interior for guiding sliding withdrawal of the handheld specimen collection tool from the handheld assay device for depositing bodily specimen on said specimen slide.

12. The device according to claim 10 further comprising a removable protective foil for protecting at least said cartridge housing top face, said protective foil being manually removable subsequent to sliding withdrawal of the handheld specimen collection tool from the assay device.

13. The device according to claim 1 and further comprising a specimen slide securing arrangement for securing the specimen slide in said final uppermost specimen examination position wherein said specimen slide securing arrangement enables an irreversible elevation of said specimen slide from said initial lowermost specimen introduction position to said final uppermost specimen examination position.

14. The device according to claim 1 wherein said cartridge housing includes a manually operated specimen slide elevation arrangement for slidingly elevating said specimen slide from said initial lowermost specimen introduction position to said final uppermost specimen examination position.

15. The device according to claim 14 wherein said specimen slide elevation arrangement includes:

a leading manual operated specimen slide elevation actuator under said specimen slide in said initial lowermost specimen introduction position for sliding along a leading opposite pair of specimen slide elevation tracks in said cartridge housing peripheral face each including at least an inclined elevation leg, and

a trailing manual operated specimen slide elevation actuator under said specimen slide in said initial lowermost specimen introduction position for sliding along a trailing opposite pair of specimen slide elevation tracks in said cartridge housing peripheral face each including at least an inclined elevation leg,

said leading manual operated specimen slide elevation actuator and trailing manual operated specimen slide elevation actuator being spaced apart for manual displacement along their corresponding opposite pairs of specimen slide elevation tracks towards one another from an initial set-up position to a final examination position, said initial set-up position corresponding to said initial lowermost specimen introduction position and said final examination position corresponding to said final uppermost specimen examination position.

16. The device according to claim 1 wherein said cartridge housing top face includes a liquid reagent port for manual dispensing of liquid reagent onto said specimen slide in said initial lowermost specimen introduction position to react with at least some bodily specimen on said specimen slide.

17. The device according to claim 1 wherein said cartridge housing bottom face is lined with hygroscopic material to absorb liquid residues displaced from said specimen slide pursuant to elevation of said specimen slide to said final uppermost specimen examination position.

18. The device according to claim 1 and further comprising an odor sensor for obtaining odor information from the bodily specimen deposited on the specimen slide.

19. Assay apparatus for use with the handheld assay device for diagnostic purposes of a bodily specimen, the assay device enabling ElectroMagnetic Radiation (EMR) examination of the bodily specimen at at least one predetermined EMR wavelength, the assay device having an upright assay device centerline and a horizontal longitudinal assay device centerline perpendicular to the upright assay device centerline, the assay device having:

(a) a cartridge housing including a cartridge housing top face, a cartridge housing bottom face opposite said cartridge housing top face, and a cartridge housing peripheral face between said cartridge housing top face and said cartridge housing bottom face to bound a cartridge housing interior,

the cartridge housing having a specimen introduction port for enabling introduction of bodily specimen into the cartridge housing interior,

the cartridge housing bottom face including at least one throughgoing aperture for providing access to the cartridge housing interior,

(b) a specimen slide snugly accommodated in said cartridge housing interior and slidingly deployable from an initial lowermost specimen introduction position in an unused assay device to a final uppermost specimen examination position in an used assay device, the initial lowermost specimen introduction position and the final uppermost specimen examination position correspondingly remote from and adjacent the cartridge housing top face,

the specimen slide being intimately juxtaposed against the cartridge housing top face in the final uppermost specimen examination position for compressing at least some bodily specimen between the specimen slide and the cartridge housing top face subsequent to a bodily specimen being deposited on the specimen slide in the initial lowermost specimen introduction position,

the assay device having a line of examination through the cartridge housing and the specimen slide wherein the line of examination is co-directional with the upright assay device centerline for enabling examination of the compressed at least some bodily specimen at the at least one predetermined EMR spectrum;

(c) a built-in liquid reagent dispensing arrangement for dispensing a liquid reagent on the specimen slide, the built-in liquid reagent dispensing arrangement including a longitudinal directed barrel lateral to the horizontal longitudinal assay device centerline,

the barrel including an exposed leading seal, a trailing seal and liquid reagent between the leading seal and the trailing seal,

the barrel having a liquid reagent dispensing port for dispensing liquid reagent on the specimen slide for reacting with bodily specimen deposited thereon,

the leading seal and the trailing seal having an initial pre-liquid reagent dispensing position in an unused assay device and a final post-liquid reagent dispensing position in an used assay device,

the trailing seal being urged past the liquid reagent dispensing port on being urged from the initial pre-liquid reagent dispensing position to the final post-liquid dispensing position,

the assay apparatus comprises;

(a) apparatus housing including;

i) a tray having a tray pocket for snugly interchangeably receiving an assay device, and

ii) a motorized arrangement for linear reciprocation of said tray between an outermost position relative to said apparatus housing for interchanging an assay device and an innermost position relative to said apparatus housing;

(b) a plunger for insertion into an assay device'"'"'s barrel for dispensing liquid reagent onto a bodily specimen;

(c) a specimen slide elevation member for insertion through an assay device'"'"'s underside throughgoing aperture for urging its specimen slide from its initial lowermost specimen introduction position to its final uppermost specimen examination position;

(d) a digital image acquisition arrangement for obtaining digital images of at least a bodily specimen contained in an assay device; and

(e) a controller for controlling at least said motorized arrangement and said digital image acquisition arrangement.

20. Apparatus according to claim 19 wherein an inward movement of said tray from said outermost position to said innermost position leads to insertion of said plunger into an assay device'"'"'s barrel before said tray reaches said innermost position.

21. Apparatus according to claim 19 wherein an inward movement of said tray from said outermost position to said innermost position leads to insertion of said specimen slide elevation member through an assay device'"'"'s underside throughgoing aperture for urging an assay device'"'"'s specimen slide to its final uppermost specimen examination position before said tray reaches said innermost position.

22. Apparatus according to claim 19 wherein an inward movement of said tray from said outermost position to said innermost position leads to said digital image acquisition arrangement acquiring digital images of at least a bodily specimen contained in an assay device.

23. Apparatus according to claim 19 wherein said tray includes:

i) an external tray member having said tray pocket,

ii an internal tray member longitudinally slidingly reciprocal between an assay device insertion/ejection position of an assay device in said tray pocket at said outermost position and an actuated assay device position of an assay device in said tray pocket, and

iii) a restraining mechanism for selectively restraining movement of said internal tray member relative to said external tray member.

24. Apparatus according to claim 23 wherein said internal tray member includes said plunger and a throughgoing slit, said external tray member includes a spring biased specimen slide elevation member, the arrangement being such that in said assay device insertion/ejection position, said plunger is not inserted in the assay device'"'"'s barrel and said internal tray member blocks said spring biased specimen slide elevation member, and in said assay device actuated position, said plunger is inserted in the assay device'"'"'s barrel and said spring biased specimen slide elevation member exits through said slit into the assay device'"'"'s underside throughgoing aperture for urging its specimen slide from its initial lowermost specimen introduction position to its final uppermost specimen examination position.

25. Apparatus according to claim 19 wherein said digital image acquisition arrangement includes a single digital image camera having a first optical path for acquiring a first optical path image of a bodily specimen and a second optical path for acquiring a second optical path image of a bodily specimen wherein said digital image acquisition arrangement is operative to instantaneously acquire images along either said first optical path or said second optical path.

26. Apparatus according to claim 19 and further comprising a used assay device detector for determining whether an assay device newly inserted in said tray pocket is an unused assay device before the assay apparatus'"'"'s operation for diagnostic purposes.

27. Apparatus according to claim 26 wherein said used assay device detector optically detects a position of a newly inserted assay device'"'"'s seal compared to a benchmark position for an unused assay device for determining whether the newly inserted assay device is an unused assay device.

28. Apparatus according to claim 26 wherein said used assay device detector determines electric motor power consumption for initially displacing an assay device'"'"'s leading seal compared to a benchmark electric motor power consumption for determining whether the newly inserted assay device is an unused assay device.