Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
  • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
  • G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/02—Adapting objects or devices to another
  • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0809—Geometry, shape and general structure rectangular shaped
  • B01L2300/0825—Test strips
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/04—Moving fluids with specific forces or mechanical means
  • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
  • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces

Definitions

• the subject of this invention is a device for the carrying out of rapid diagnostic tests on samples of liquids and in particular tests on urine samples on immunochromatographic membranes, such as HCG Human Chorionic Gonadotropin (pregnancy), FSH Follitropin (identification of the follicular phase), LH Human Luteotropin (identification of the fertile period) etc.
• immunochromatographic membranes such as HCG Human Chorionic Gonadotropin (pregnancy), FSH Follitropin (identification of the follicular phase), LH Human Luteotropin (identification of the fertile period) etc.
• Such devices essentially include a porous analysis strip containing a predetermined quantity of reagent which changes colour upon contact with the liquid to be analysed in giving an almost immediate indication of the test result.
• the simplest devices consist of the porous analysis strip only, with an absorbent end, which is soaked, for example by immersion in the liquid to be analysed.
• Such devices even though simple and of low cost, turn out to be unsuitable from a hygienic point of view as they require direct contact with the user's hands, even after immersion in the sample and necessarily require that the sample be collected in a suitable container.
• the device comprises a prolonged casing, made in two halves, between which the porous analysis strip is included together with a small absorbent pad, positioned so as to protrude from one end of the casing.
• the device is completed by at least an external protective hood which is applied to the casing in such a way as to cover the window during the taking of the liquid sample to prevent the liquid from entering through the window and thus prejudicing the test result. After the pad has been soaked in liquid, the protective hood is removed from the casing and placed on its other end so as to cover the pad.
• This device is of rather complicated construction, and, being made in a variety of separate pieces, therefore costly. It also requires particular care on the part of the user who must necessarily use both hands to place the hood at one end or the other at different points in the test and this can include hygiene problems with the possibility of contact of the sample with the hands not being absolutely excluded.
• JP-0712467, JP-0712468, JP-07120465 and JP-07120466 describe devices of this same type and of different conformations but all lacking any protection of the reading window against contamination by the liquid sample.
• An object of the invention is to supply a device for rapid diagnostic tests on samples of liquids which can be used simply and safely by unskilled persons and which assures the maintaining of conditions of hygiene during use.
• Another object of the invention is to supply a device which is relatively simple and of low cost.
• a further object of the invention is to supply such a device which can be manipulated with one hand only.
• the device according to a version of the invention has a casing containing the porous analysis strip and a liquid absorbent pad which protrudes for a certain distance from its end.
• This casing has at least one window and is housed in an axially sliding external shell which is also provided with a movable window to register with the window in the casing.
• the external shell is movable from a backward position in which it leaves the pad uncovered and closes the window in the casing below, to allow the sampling of the liquid without risk of contamination of the window, and a forward position in which it covers the protruding pad and superimposes its window on the one in the casing underneath to allow the result of the test to be seen.
• the porous analysis strip and the absorbent pad are carried by a sliding cursor inside the containing casing and having a control protruding from a longitudinal slot cut in the casing so that it can be moved from a position of liquid sampling, in which the pad protrudes from the casing, to a position of reading in which the porous analysis strip is in correspondence with the window in the casing.
• Figure 1 is a plan view of a form of the device according to the invention, with the pad exposed;
• Figure 2 is a side view of the device of Figure 1;
• Figure 3 is a plan view similar to the one in Figure 1, with the pad covered and the window in register;
• Figure 4 is an end view taken from the right-hand side of Figure 1;
• Figure 5 is an exploded view of the device.
• Figure 6 is an axono etric view of the assembled device, without its external protective shell;
• Figure 7 is a plan view of a second form of the device according to the invention, with the pad exposed;
• Figure 8 is a side view of the device of Figure 7;
• Figure 9 is a plan view similar to that of Figure 7, with the pad covered and the analysis strip in the reading position, registered with the casing window;
• Figure 10 is an exploded view of the device in Figure 7
• the device according to the invention includes a casing or body 1, enclosing a porous analysis strip 2 and an absorbent pad
• the casing 1 has a long form and consists of two halves, one lower 5 and one upper 6, substantially equal and fitting together so as to accommodate inside them, the porous reagent strip 2, visible through an oval window 7 situated in the upper half 6, and to press on and off the pad 3, which is also of elongated shape and which is in contact with the strip 2, of which it constitutes a prolongation. To allow the exit of the pad
• the walls of the two halves of the casing 1 have a hollow space 8, at one end.
• the casing or body 1 on the side opposite to the pad 3 has a slight widening 9, creating a couple of lateral spaces 10.
• the external shell 4 has an opening 11 at one end to insert the elongated casing 1 and another opening 12 at the other end (figure 4) for the passage of the pad 3.
• An oval window 13, is placed on the upper side of the shell 4, with dimensions not less than those of the window 7 on the casing 1 and which can be brought into register with the latter to allow the reading of the porous strip 2.
• means of reciprocal attachment can be provided, achieved, for example by a couple of lateral notches 15 cut in the casing 1 and by corresponding flexible tongues 16 on the internal walls of the shell 4, preferably in correspondence with the opening 11.
• the flexible tongues 16 are oriented in such a way as when the casing 1 is inserted in the shell 4, they bend and pass over the notches 15, whereas when moved in the opposite direction, they engage with the notches 15.
• the device according to the invention is in the arrangement shown in Figure 1, with the outside shell 4 withdrawn on the casing or body 1, so as to abut against the couple of lateral spaces 10 on the casing 1.
• the pad 3 protrudes from the device and can so be used to collect the sample, either by immersing it into a collection container or by placing it directly in the patient's urine flow.
• the user's fingers which hold the device at the opposite end from the pad 3 are well distant from the collection area and are therefore well protected.
• the window 7 in the casing 1 is protected by the external shell 4, in eliminating all risk that urine spray could directly reach the porous strip 2 below.
• the user slides the outside shell 4 on the casing 1, until the flexible tongues 16 engage with the corresponding notches 15.
• test result is not directly visible on the porous strip 2, but requires special reading as occurs in some types of analysis
• the device according to the invention in the condition shown in Figure 3, is taken to the reading machine, to be considered as known.
• Both the casing 1 and the shell 4 are conveniently made in plastic material, polystyrene for example, and the two halves 5 and 6 of the casing 1 can be joined together in any way, even by welding, ultrasonic welding for example. It can be furthermore foreseen that the pad 3 is mainly or completely housed in the casing 1 and is accessible to be soaked in liquid through holes made in the casing. From what has been written above, the advantages of the device according to the invention appear evident and it can also be operated with one hand. To facilitate this, grips can be provided on the casing 1 and/or on the outside shell 4. For example a finger hold can be provided on the casing 1 and/or a couple of lateral incisions with curved profile on the outside shell 4 or on the casing 1.
• the outside shell 4 can be longer than shown in the attached Figures, so as to allow an intermediate position between the two shown in Figures 1 and 3, position in which the shell 4 covers both the pad 3 and the window 7 of the casing 1.
• the porous analysis strip 2 and the absorbent pad 3 are supported by a cursor 30, moveable axially inside the casing 1, from a position in which the pad 3 protrudes from the casing to allow the collection of the sample liquid (Fig. 7), to a position in which the pad 3 is covered by the casing 1 and the analysis strip 2 is in correspondence with the window 7 in the casing to allow reading. Movement of the cursor 30 is by means of a control 31, protruding through a longitudinal slot 32 in the casing 1.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Hematology (AREA)
• Molecular Biology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Analytical Chemistry (AREA)
• General Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Endocrinology (AREA)
• Immunology (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Medicinal Chemistry (AREA)
• Cell Biology (AREA)
• Reproductive Health (AREA)
• Microbiology (AREA)
• Clinical Laboratory Science (AREA)
• Food Science & Technology (AREA)
• Biotechnology (AREA)
• Physics & Mathematics (AREA)
• Biochemistry (AREA)
• General Physics & Mathematics (AREA)
• Pathology (AREA)
• Sampling And Sample Adjustment (AREA)
• Investigating Or Analysing Biological Materials (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=11372929

Family Applications (1)

Country Status (4)

Families Citing this family (15)

Family Cites Families (5)

• 1996
  • 1996-01-17 IT IT96MI000069A patent/IT1281738B1/it active IP Right Grant
  • 1996-12-23 AU AU13061/97A patent/AU1306197A/en not_active Abandoned
  • 1996-12-23 EP EP96944653A patent/EP0874690A1/en not_active Withdrawn
  • 1996-12-23 WO PCT/EP1996/005830 patent/WO1997026083A1/en not_active Application Discontinuation

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events