JP2003512624A - Apparatus with test strip with pretreatment section with lid - Google Patents

Apparatus with test strip with pretreatment section with lid

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Publication number
JP2003512624A
JP2003512624A JP2001532099A JP2001532099A JP2003512624A JP 2003512624 A JP2003512624 A JP 2003512624A JP 2001532099 A JP2001532099 A JP 2001532099A JP 2001532099 A JP2001532099 A JP 2001532099A JP 2003512624 A JP2003512624 A JP 2003512624A
Authority
JP
Japan
Prior art keywords
lid
test
layer
pretreatment
sample
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.)
Pending
Application number
JP2001532099A
Other languages
Japanese (ja)
Inventor
エイヴォル, ヘレナ スヴェンス,
Original Assignee
オイ メディックス バイオケミカ エービー
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
Priority to FI19992286 priority Critical
Priority to FI992286 priority
Application filed by オイ メディックス バイオケミカ エービー filed Critical オイ メディックス バイオケミカ エービー
Priority to PCT/FI2000/000914 priority patent/WO2001029558A1/en
Publication of JP2003512624A publication Critical patent/JP2003512624A/en
Application status is Pending legal-status Critical

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements

Abstract

(57) [Summary] The present invention relates to a test apparatus provided with a pretreatment section fastened by a hinge (A) and covered by a lid (2) having an opening (3). The pretreatment is mounted on the same backing support (1) as the test strip (not shown). The lid (2) and the lid of the backing support are provided with means (7, 8 and 9) which support, secure and secure the position of the pretreatment layer and a compartment ( 6) and adjust the flow of sample solution and diluent. Test equipment is useful in field tests and bedside methods, especially in emergency situations where rapid results are required.

Description

Description: FIELD OF THE INVENTION [0001] The present invention comprises a lid mounted on the same backing support as a test strip.
With pretreatment and means for controlled adjustment of sample and diluent flow
Test equipment. In addition, a pre-processing step which consumes some time by the above-described apparatus is also included.
Methods for performing assays directly from commonly needed samples are disclosed. BACKGROUND OF THE INVENTION Some biological samples, especially whole blood, serum, urine, stool, saliva, sputum for diagnosis
Such samples taken from synovial fluid, etc. are used for particle removal, agglutination, chemical treatment, specific components
Requires a pretreatment step including release of lipase, immunization and the like. [0003] Typically, before performing a test, a whole blood sample is subjected to blood cells and other interfering or interfering
Agglomerated and centrifuged to remove the factors that form. Many new and quick
Bedside trials have been developed, which can be used in ambulances and hospitals during surgery.
It would be perfect for a quick bedside test in an emergency. Only
And centrifugation is a retarding factor, which makes the use of the test in critical situations critical.
Hinder. There are also many systems for removing blood cells on test strips or test equipment.
Stems have already been disclosed (EP 806666, EP 323605, EP
582231 and WO 98/22824). [0004] Several problems are associated with the known systems. The problem is, for example,
Backflow and overflow, i.e. the redundant fluid is filtered
And leaves the reagent in the reagent layer, causing interference in the detection zone. The known method
Another problem associated with the equipment is that only one filter pad or layer
Often not enough to retain blood cells and all interfering factors, neither
It is not carried. Accordingly, it is an object of the present invention to have a test strip and regulate sample and diluent flow.
Test apparatus with a pretreatment section with an improved lid having means for
That is. The device is suitable for emergency situations, especially ambulances where coagulation and centrifugation are not feasible
It is useful for use within or where the steps are too time consuming.
The test device according to the invention offers great accuracy even for complex immunological analyses without sample preparation
With can be implemented quickly. In addition, this test equipment can
It can be modified to meet the requirements of the law. SUMMARY OF THE INVENTION This analytical test with a closed pre-treatment system assembled with test strips
The characteristics of the test device are defined in the claims. More specifically, the invention relates to a sample and
And a test device for obtaining controlled regulation of diluent flow. The test equipment is
Before performing the verification on the test strip placed on the
It has a pre-treatment section for treating materials and removing interfering substances and particles. Pre-processing unit is open
A lid (2) having (3) is provided. The lids are stapled horizontally on top of each other
Test strip placed on a backing support (1) with a lid
Before having one or more pretreatment layers (4) assembled in capillary flow contact with (5)
Cover and protect the processing system. Backing support (1) and lid (2) in front
Keep layers (4) in their correct position in the treatment system and place them in the test strip.
Means (5) for coupling with the step (5). Before securing and fixing the layers
The means are responsible for the controlled regulation of the flow of the sample solution. Said means is also
An excess liquid collection compartment (6) is formed which contains the sample and reagents impregnated in the layer.
Allows rapid addition of buffers or other liquids to allow for more efficient dilution
And The compartment (6) minimizes the negative effects of spills and backflows and has a predetermined sequence
A uniform and controlled passage through each layer and subsequently into the test strip (5).
Allow for Test strips show the results with more than one eye
Alternatively, it can be recorded as a readable zone. [0007] Furthermore, the present invention provides rapid bedside or on-site without sample pretreatment.
A method for performing a test in a computer. Sample is backing support of test equipment
(1) The diluent or aqueous driving solution is added into the opening (3) in the top lid (2)
Is added. Diluents may contain reagents that are essential for the proper performance of the test.
it can. The diluent, which can be buffer or pure water, comes before the sample solution and diluent.
It can be driven in a controlled manner through layers in the processing system. Particles are trapped
And the interfering substances can be removed by physical and / or chemical means within the layers of the pretreatment system.
Removed or reacted. Excess or excess fluid is applied to the bar (9
. 1) and the side support (8.1) and the bar (9) in the lid of the backing support.
. Collected in the compartment formed by 4). BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a backing support (1) with a lid and a lid (2) with a hinge (A).
FIG. The lid to protect the layers in the pretreatment system has a lid attached
Means (C) for snapping in place. FIG. 2 shows a closed lid (2) snapped onto the backing support (1).
And the test apparatus with the test strip (5) fixed in position
It is a schematic diagram. The lid (2) is provided with a shaped or non-shaped opening (3).
The sample solution and the diluent or drive solution, if present, may be added during the opening of the
it can. FIG. 3 shows a sectional side view of a backing support (1) with a lid having an open lid (2).
FIG. The opening (3) for adding the sample solution is an intersection
appear. The two pretreatment layers (4.1) and (4.2) and the test strip (5)
Shown schematically. FIG. 4 shows an open lid (2) and an opening (3) shown as a round dot or a rounded area.
Test strips with and with pretreatment layers (4.1) and (4.2)
Figure 3 shows a top view of a backing support (1) with a lid having a lip (5). FIG. 5 shows the pretreatment layer (4.1) snapped onto the backing support (1).
Backing support with lid having lid (2) covering and protecting (4.2) and (4.2)
It is sectional side view of G (1). The pretreatment layer is applied to the test strip through the bonding pad (B).
Capillary flow contact with the cap. All layers are in their correct position. FIG. 6 shows a transparent closed lid snapped onto the backing support (1).
It is sectional drawing seen from the top which has (2) and opening (3). Usually invisible due to transparency
The pretreatment layer (4) covered with the lid is in their correct position and the test strip (5)
) And capillary flow contact. Transparency is not a requirement of the present invention. Transparent
Development work for experimental purposes that allows studying the nature of what is going on in different layers
Sometimes used. FIG. 7 has an open lid (2), no pretreatment layer and no test strip
It is sectional side view of the backing support (1) provided with the lid. In the figure, the layers are
Means for securing and securing in their correct positions are shown. These means
Includes tap (7), side support (8) and bar (9). FIG. 8 has an open lid (2) without a pretreatment layer and without a test strip
It is the schematic which looked at the backing support (1) provided with the lid from above. Tap (7)
, Side wall projections or side supports (8), bars (9) and sump for excess fluid
The area forming the compartment (6) which acts as a basin is shown. FIG. 9 snapped into place without the pretreatment layer and test strip
FIG. 4 is a sectional side view of a backing support (1) provided with a lid having a lid (2). this
The figure clearly shows the space provided for the layers. FIG. 10 shows a transparent closure snapped onto the backing support (1).
With open lid (2), without pretreatment layer and without test strip
It is sectional drawing. Form openings (3) and taps (7) and side supports (8)
The side wall projections are shown in this figure. A bar (9.4) forming a reservoir in the compartment
It is clearly shown. DETAILED DESCRIPTION OF THE INVENTION Definitions In the following description, most terms are used in diagnostics, immunochemistry, biochemistry and enzymology.
It is used as commonly used for methods and apparatus. But,
Some terms are used in somewhat different or broader directions. Give such terms
Provide a clearer and more consistent understanding of the specification and claims, including the scope of
To do so, the following definitions are given. In the present invention, the term “means for securing and fixing the layer” refers to a sample solution.
And responsible for the controlled adjustment of the appropriate diluent flow. They are also
A compartment for collecting excess fluid or liquid is formed. This compartment provides efficient dilution of reagents.
To be able to read. It minimizes the effects of overflow. At the same time, the negative backwash effect is avoided
Can be The compartment is to be tested through each layer in a predetermined order and for subsequent test strips.
Allows a uniform and controlled passage through the pump. “Securing and securing layers
Are provided by taps, side supports and bars, which are
Long or short protrusions in the lid of the stick lid and backing support of the device
It is Ki. This means has a somewhat different function. The terms “backwash effect” and / or “backflow effect” act as sample solution and diluent
Liquid drives the sample solution in the wrong direction, i.e. in the opposite direction to the intended direction
When you mean the phenomenon. In the worst case, the sample flows over the reaction zone and the reagents
Backwashed. In the present invention, uncontrolled backwashing is not possible. Negative backwash effect eliminated
Is done. Excess fluid is collected behind the pretreatment layer in the compartment, which
Excess fluid flows from the compartment through the filter layer to the reagent area of the bonding pad and test strip.
Empty as it moves through the capillary area of the absorbent pad at the opposite end of the test strip.
Because it is The term “tap” refers to a peg or tag on the bottom of the device's plastic backing
Means small protrusions. The taps support the filter means and they
On the backing support. Instead, a grid is used
be able to. Therefore, the sample solution and diluent flow along the backing support.
I can't. In other words, the sample solution must not first pass through the filter.
It is still prevented from passing through the test strip. The term “side support” refers to a protrusion in a backing support that holds the pretreatment layer in a fixed position.
I mean Ki. One side support behind the backing support lid is overflowing
Helps form the body compartment. Also, the side support in the side wall is
Prevent migration into the test strip without passing through the physical layer. Since the term “bar” is “toothed” to provide better grip,
Ridges and ribs. Such "toothed bar" is present in the lid and tested
Keep the strip in a firm grip. Bars are also compartments for excess fluid
Walls can be formed to prevent excess fluid from flowing under the filter layer. Ma
Bars, together with side supports, secure the pretreatment layers in their correct position. The terms “test strip” and / or “test stick” are used, for example, on a backing
Laminated with nitrocellulose or nylon membrane mounted on top
Means strip or stick. Test strip or stick
A drug, preferably an immunoreagent such as a mono- or polyclonal antibody,
It further comprises a recordable or visible marker or marker. Or testing
Tick can be enzymatic, chemical or biochemical. The term “opening” refers to a shaped or non-shaped for adding sample and / or diluent.
It means a molding hole. General Description of the Invention It is an object of the present invention to pre-treat a sample before performing an immunochromatographic test
The present invention can be implemented by providing an analytical test apparatus including the above system. In one preferred embodiment of the present invention, test strips can be produced as follows.
A nitrocellulose or nylon membrane is placed on a plastic backing or on a plastic backing.
Attached between stick strips, one of nitrocellulose or nylon membrane
With a bonding pad in intimate contact with the edge and an absorbent pad attached to the other end of the membrane
I have. Narrow bands on nitrocellulose or nylon membranes
Coated with a monoclonal antibody. Colored or fluorescent latex particles, as well as
Lloyd particles, gold sols, magnetic particles, etc.
It can be coated with a cloned antibody. The coated particles are preferably stripped.
Dried on a zone close to the pretreatment section of the pump or in a layer placed in the pretreatment section
. Particles are so small that they are free through pores and strip material
Can flow to The layers and test strips are tested through a suitable filter layer.
On a plastic backing for capillary flow contact of the sample liquid to the test strip
To be placed. However, the test strip is not limited to the test strip embodiment described above.
Many different test devices and determination methods that require sample pretreatment are
Can be used in this test device including elemental, chemical or biochemical test strips
You. The test device of the present invention may comprise one or more layers, preferably hydrophilic stapled together.
A pre-treatment area with a lid, comprising a layer of a water-absorbing material. They are samples
Provides a means for physical or chemical treatment of The pretreatment area has good moisture
Lids or covers made of plastic material with elasticity and test strips with each other
And means for keeping the layer fixed in a predetermined position. The cover or lid is secured to the backing support by fastening means such as hinges or pivots.
Attached to port or optionally released. Fastening means is backing support
Can be placed on either side of the
Ie, the outer or upper end of the backing support. If the hinge is on either side
The sample solution flow may not be uniform, i.e.
It can be different on different sides of the layer. When pretreatment layers and test strips are assembled
, The lid is snapped over the pre-processing part. [0032] The layers in the pretreatment system include one or more different layers, which are the physical arrangement of the sample.
Enables chemical pretreatment. Said physical treatment may involve the separation of certain components or particles or
Includes means for removing or adjusting the mobility of components in the sample solution. Physical processing
Filter with different pore sizes or shaped pores to allow for
Luter or membrane is used. Alternatively, having a different so-called V-pore,
I.e. filters with pores with different diameters on each side of the filter or each
Filters with different pore sizes on the sides separate particles of different sizes in the sample solution
Used to The layers in the pre-treatment section provide physical processing as well as chemical processing of the sample.
Means can be included. Said means for chemical treatment is agglutinating
), Flocculants, lysis, buffer and ionic strength regulators and immunocapturins
g filters or membranes containing certain compounds or compositions that act as agents
is there. The layer can also be colored, phosphorescent or fluorescent latex particles, colloids, gold sols
As a carrier for so-called labels or markers, including liposomes, etc.
Can be. It can also release certain components from the determined substances
Chemicals can also be added. The test device is of good quality, such as polypropene, wettable, preferably plus
Includes a support bag prepared from a tic material. For hinges or pivots
It is essential that the material be substantially non-brittle. In addition, the material contains interfering chemicals
Should not be. For example, release agents or plastics for the preparation of lids and backing supports
Use of agents is not recommended. Surface treatment is not recommended. The backing support is preferably made from the same material as the backing support
It has a lid. The lid covers the pre-treatment section and at the same time makes a capillary flow contact with the pre-treatment layer.
Secure the test strip. The sample solution is allowed to flow before entering the test strip by capillary flow.
All necessary layers. Backing support and test equipment lid
Acts as protective equipment for test strips during storage and transport. Otherwise
The test strip itself is not covered. The inside of the lid and the pretreatment part of the test apparatus are provided with taps (7), side supports (8) and
And bars (9), which test the layers of the pre-treatment section with each other and test
Secure with the strip. Test strip and pretreated sample solution
Contact between them is only possible through the opening in the lid. Sample solution is pre-treated by capillary force
Through the test strip. The lid may be a pretreatment layer between the sample solution and the test strip, for example a filter.
And configured to allow reliable capillary flow contact through a predetermined sequence.
It is. The pretreated sample solution moves into the test strip only through the pretreatment layer.
You. Excess or excess fluid is applied to the bar (9.4) in the backing support lid.
Is temporarily collected in the formed compartment (6). The test strip is placed in the test apparatus during manufacture and is ready for use.
Can be sold as a unit. Alternatively, test strips, test equipment
And the layers for the pretreatment section are sold separately and assembled in the desired manner before use
Can be Samples include whole blood, serum, urine, stool, saliva, sputum, synovial fluid, amniotic fluid, and various types of rings.
Can be an environmental sample. Is the specific substance and / or solid substance generally a sample?
It is essential that they can be removed from. This is a parameter with the appropriate pore size.
This can be achieved by means of a filter such as a pad. Sometimes the sample is dried
It must be chemically treated to separate interfering or interfering components. Time
Some specific or active ingredients in substances determined from the sample
It must be released before being set. Such components may be, for example, certain proteins or
An epitope or active site in a hapten. Release is for example a surfactant, reduction
It can be carried out by extraction with various reagents such as agents, acids and the like. reagent
Removes, for example, sulfur bridges, lipids, and the like. The test device is preferably used with samples requiring different types of pretreatment
. The part with the lid of the test device in close contact with the test strip is one of the materials
Layers, or may contain several layers of the same material or several layers of different types of material
You. These materials can have different pore sizes, for example,
Can be used. They can be impregnated with various types of reagents
They can act as reagent layers or as immunocapture layers. this
These layers can be used separately or in any combination with each other
. When the sample is whole blood, blood cell separation is usually required. This is preferred
Uses two layers of material in intimate contact with the lateral flow test strip.
And can be achieved by: The upper layer preferably acts as a sample pad
I have. The sample pad separates blood cells from whole blood with
Or allow the serum to be moved forward toward the test strip. The sample is, for example, serum, which is, for example, rheumatoid factor, heterophilic anti-mouse
Antibodies (HAMAs), heterophilic anti-animal antibodies (HAAAs) or the like
When included, the part with the lid is impregnated with reagents to eliminate these interferents
Layer can be included. Alternatively, the serum sample acts as a sample pad
It can be applied to the desired layer and eluted with a buffer containing such reagents. Thing
Indeed, either a driving solution, water or, preferably, a buffer solution is required for the implementation of the test device.
It may be essential to be added. The driving solution dissolves and mixes the sample and reagent.
And pass them through the pretreatment layer (s) and into test strips.
Drive into a band where the fruit can be read. But the buffer is like a backflow
It is known to cause serious problems. The present invention relates to a filter or filters.
Collecting any liquid flowing backwards into the posterior compartment,
Solves the problem, but then the compartment is efficiently emptied by capillary forces,
The reagent is transferred to a test strip. When the sample is a urine or stool suspension, the part with the lid is the same or different
One or more layers of a filter having a pore size can be included. Has a coarse pore structure
The front filter can be placed on one pretreatment layer with a fine pore structure.
Wear. Large and small particles continue before the sample liquid reaches the test strip.
Can be filtered out. The sample has a very low pH value or a very low ionic strength due to eg preservatives
When it is a urine sample with
Before treatment in a layer with one or several buffers. When the sample was saliva, sputum, synovial fluid or amniotic fluid, it was impregnated in the layer of the pretreatment section.
It may be preferable to use a mucolytic agent. The sample is added to the test device through an opening in the lid of the pretreatment section. The sample volume is
It is such that no additional reagent solution is required. If the sample volume is very small
A diluent solution, preferably an aqueous buffer, is passed from the pretreatment section to the end of the test strip in the device.
It is necessary to obtain the flow of liquid to the part. It is preferable that the sample liquid is added to the opening in the lid in the form of drops. First drop of liquid
Spreads through the top layer of the filter, i.e., a hydrophilic, water-absorbing sample pad
. Further drops flow through the sample pad into the underlying filter layer and backing
It extends horizontally into the back compartment (6) in the port lid. All filter materials are interchangeable
And the joining pad (conj) of the water-absorbing filter or test strip (5)
ugate pad) (B). Pretreatment layer or filter is plastic
On the taps (7) in the tapping device, which, on the contrary,
Through a filter and / or reagent layer in a defined order and plastic equipment
Side support in such a way that it is forced to flow along the inner surface of the
8). The sample liquid, with or without diluent or drive solution, is placed under the filter
-Spread along (one or more) (4), at the end of the test strip (5),
That is, the bonding pad (B) is wetted. Excessive lid at back end of backing support
The fluid collection compartment (6) allows the liquid to move forward along the bonding pad (B) and further into the test space.
Driven by the capillary force provided by the absorbent pad in the opposite end of trip (5)
It is emptied as it flows through the membrane of the test strip. The microspheres dried on the bonding pad, for example latex particles covered with antibodies,
Redissolve and move forward with the liquid front into the reaction area on the test strip membrane
I do. The absorbent pad in contact with the test strip membrane absorbs excess liquid,
Ensure that compartment (6) will be empty. The sample is preferably pipetted into a hole or opening on the cover or lid of the test device.
And optionally a suitable buffer solution is added to drive the sample through the layer. [0051] The solution is passed through a first filter layer to remove larger components or particles.
Will be forcibly moved inside. Behind the bed is a compartment (6) in which excess liquid collects.
So that it passes by and over the pretreatment layer (4).
) Is not contacted with the nitrocellulose or nylon membrane. In addition, backing
The side of the support (1) and the lid (2) are used to hold the various layers in place.
Steps (7, 8 and 9) are provided. The means provided are, for example,
Shape, more preferably in the form of a tap (7). Grid or tap (7
) Supports the pretreatment layers, so they touch the backing support (1)
Never. Side support (8) allows sample solution to pass along the side of the filter
To prevent Furthermore, the lid (2) and the support (1) comprise a bar (9). lid
(2) is equipped with a toothed bar (9.3) which allows the test strip to be placed in its place.
To keep. The backing support lid has a bar (9.4),
This bar, assisted by a port (8.1), is a compartment for excess or excess fluid
Form (6). [0052] Thereafter, the test may run on any results until the results are visible or readable.
It can be deployed without effective sabotage. The results are recorded directly. Of sample and diluent
The volume should be such that the solution is absorbed and does not remain in the excess liquid collection compartment (6)
Is preferred. Perform analysis with the test device and test strip or test stick of the present invention
Its use to do so is described in more detail with reference to the accompanying drawings 1-10. There
The reference numbers and / or letters used correspond independently of the test equipment design
Related to features. In this context, the following description and drawings are intended to be examples, which
It is understood that this invention should in no way be limited to the specific features shown in the drawings.
Should be. In contrast, the scope of protection includes the features of the device as defined in the claims.
It is intended to cover all modifications, equivalents, or alternatives. FIG. 1 shows a backing support (1) with a lid with a rim and the inside of the pretreatment system.
Prescribed by means (C) for closing the lid by snap fastening to protect the layer
FIG. 4 is a side view of the lid (2) snapped into place. Backing support and lid
The part is, in a preferred embodiment of the invention, a hinge (A) or a pin located behind the test device.
They are connected by a suitable fastening means such as a bot. FIG. 2 shows a pre-treatment which is snapped on the backing support (1) and hidden under the lid
Closed lids (2) with layers (not shown) and their fixed
FIG. 4 is a schematic view of a test strip (5). The lid (2) is preferably a sample solution and
The shaped opening (3) into which the diluent or driving solution is added and also the lid is closed
(C). FIG. 3 shows a sectional side view of a backing support (1) with a lid having an open lid (2).
FIG. The openings (3) for adding the sample solution are shown as intersecting lines,
For example, a first filter pad (4.1) and a second filter pad (4.2) are included.
The absorption area of the two pretreatment layers (4.1) and (4.2) and the test strip (5)
The area is shown schematically and the fastening means or hinges (A
) Are shown schematically. Filter (4.2) with test strip (5) and hair
The joining area that is in tube flow contact is indicated by the letter (B),
The means (C) for closing the lid by means of a clasp is shown in (C). Also shown
Are the taps (7) and the bars (9.1), (9.2) that support the layers in the pre-processing section.
) And (9.3) and a compartment (6) or reservoir for excess or excess fluid.
The side supports (8.1) and the bars (9.4) to be formed. FIG. 4 shows an open lid (2), an opening (3) for adding a sample and a pretreatment layer.
Hold the test strips (4.1) and (4.2) and the test strip (5) in the correct position.
Figure 2 shows a top view of a backing support (1) with a lid. Reservoir compartment (6)
Side support (8.1) and bar (9.1) to form
Secure the side wall projections or side supports (8.2) and layers to prevent them from passing around
The defining bars (9.1), (9.2) and (9.3) are also shown. Fastener
Steps or hinges (A) and filter layers-test strips-connection areas, joint pads
(B) as well as snap or closure means (C) are shown schematically. Trial
Enlarged view of one preferred embodiment of a toothed bar (9.3) that prevents the test strip from moving.
Are shown in detail from the rear end of the lid and backing support. FIG. 5 has an opening (3), snapped onto the backing support, and
Cover and protect the pretreatment layers (4.1) and (4.2) and test strips (5)
With a lid (2) connected to the
It is a sectional side view of a locking support (1). Fastening means or hinges (A);
Connection area, bonding pad (B) between filter (4.2) and test strip (5)
The snap-in area (C) is also shown schematically. Also shown
Are the side supports (8. 7) forming the taps (7) supporting the layers and the compartments (6).
1) and bars (9.4). The compartment area collects excess fluid, which is filtered
Prevent it from passing around. FIG. 6 shows a closed transparent lid (2) and an opening (3) on the backing support (1).
FIG. A filter connected to the test strip (5);
-(4.2) and the layer of the front filter pad (4.1) are visible. Side wall protrusion and / or
Or side supports (8.2) are also shown on each side of the filter layer; and
A side support (8.1) in the rear end is shown. The area marked with (B)
The filter-test strip connection area, ie, the bonding pad, is shown.
The nap fastening area is shown. FIG. 7 shows a lid with an open lid (2) and without a pretreatment layer and test strips.
FIG. 4 is a cross-sectional side view of the backing support obtained from one side in the vertical direction. Lid (2
) Are attached to the backing support (1) by hinges (A).
Hinge is preferably located behind the backing of the backing support (1) to allow sample flow.
Not on either side of the lid to avoid uneven movement or flow of the body. Buckin
The support consists of two parts. The lid, which is the sample pretreatment part, is covered with the lid (2)
The test section supports a test strip (not shown). Lid (2) is a shaped opening
(3), wherein the backing support is a side wall (1.1) of the backing support.
) And the inside of this side wall is shown in this figure. Lid (2) is backing
Bars (9.1) which can be of different height and width, snapped onto the support (1)
), (9.2) and (9.3) may be used to fix the filter layer
it can. They are fastening and supporting means for layers and test strips (not shown)
Act as They also allow them to collect excess or extra sample fluid
Forming a separate compartment (6) for uniform flow into the test strip or test membrane.
Can be set as possible. The backing support (1) of the lid may also be provided with a side support (8.2) and / or
Different heights which are adjusted to support filter layers of various shapes and dimensions
Tap (7). Filter layers have different thicknesses and different sizes (dimensions
)belongs to. Side support (8.1) and bar (9.4) form compartment (6)
This acts as a reservoir for excess or excess sample fluid. FIG. 8 shows a lid (2) with an open lid (2) and no pretreatment layer and test strip.
FIG. 2 is a schematic view of a backing support (1) provided with an upper part when viewed from above. Lid (2) and support
The driving back (1) is connected by fastening means or hinges (A).
The opening (3) in the lid (2) is a shaped hole into which the sample is added.
Or pipette injected. The lid (2) further comprises bars of different heights (9.1), (9.
2) and (9.3), which allow the various filter layers to be placed where desired.
keep. Bar in lid (9.1) and bar in lid of backing support (9.4)
And side support (8.1) as reservoir for excess or excess sample solution
A working compartment (6) is formed. Side supports (8.1) and (8.2) and touch
(7) separates the reservoir of the sample solution from the test strip and dispenses this fluid
Pass through a clean filter layer (not shown). FIG. 9 shows a lid with closed lid (2) but without the pretreatment layer and test strips.
It is a sectional side view of a backing support (1). The opening (3) in the lid (2) is
And the elution buffer is directed into the filter layer (not shown). H
Bars (9.1), (9.2), (9.3) and (9.
4), lateral supports (8.1) and (8.2) and taps (7) are shown
. The side wall (1.1) of the backing support (1) is shown from its inside. lid
(2) and supporting back (1) are connected by fastening means or hinge (A)
Have been. FIG. 10 shows a means for closing the lid and keeping it in place, ie, a backing support.
Transparent closed snap-fastened by snap-on means (C) on plate (1)
Top view testing device with lid (2), no pretreatment layer and test strip
Is shown. Hinge (A) is located behind the test device in the preferred embodiment of the present invention
. Openings (3) and side supports (8.2) and taps (7) are shown for example
Can be set as Side support (8.1) and bar (9.4) are too
Form a compartment (6) for excess or excess sample solution. Example 1 Whole blood was screened for the risk of developing iron deficiency anemia (IDA) during pregnancy.
Rapid test for serum ferritin levels indicate body iron storage levels. Ferritin is iron deficient anemia (
IDA) is an early marker. Because its concentration decreases before anemia occurs
This is because that. Prelatent and latent anemia reduce hemoglobin concentration
Is detectable before can be observed. During pregnancy, serum ferritin decreases towards the end. During the first three months of pregnancy
Ferritin assessment is used to predict the risk of developing late-stage IDA during pregnancy
Can be done. The rapid test described below for determining ferritin is useful for iron therapy during pregnancy.
Can be used to infer the need. The test was performed on whole blood. The cut-off value is about 40 μg / l (WHO 3rd
International Standard, code 94/572).
Positive test results indicate that the risk of developing IDA in late pregnancy was small and that iron therapy was
Was not necessary. Negative test results indicate a high risk of IDA
That iron therapy should be recommended. The test was performed using a lateral flow immunoassay using a monoclonal antibody against human ferritin.
Based on epidemiological chromatography. One antibody is bound to the colored microspheres and another is
Partitioned over the membrane solid phase. The test device comprises a lateral flow test strip and a device for the separation of red blood cells from whole blood.
Composed of filters. This filter is installed in the pretreatment section with a lid
Was done. The test device first placed the test strip in a plastic device and then filled
Assembled so that the tar layers are mounted in those places and finally the lid is closed
Was done. Test equipment packaged in aluminum foil pouch with silica gel bag
. Test run 10 μl of whole blood is pipetted into the lid opening, followed by 3 drops of elution buffer
Was added. Red blood cells were retained by the filter, but serum moved further and hair
Flow along the test strip due to tube forces. Test results are visual or leader
Was read 5 minutes after addition of the elution buffer. One line in the test window (control line)
Indicated a negative test result. The two lines in the test window (test line and control line) are positive
Fruit. Example 2 Rapid test to screen for the presence of environmental contamination Samples for environmental mold analysis, eg, Stachybotrys chartarum analysis
Collected from appropriate sites identified by researchers to be sufficiently representative of the
Was done. Samples are taken from sites containing building materials, other supports, accumulated dust, etc.
Was. The sample was transferred into a tube containing a buffer solution and carefully shaken. Sample suspension
The suspension was then transferred to a test device. Test equipment confirms Stachybotrys chartarum
The test consisted of an immunochromatographic test stick and a pretreatment device. lid
A pre-treatment device equipped with a two-piece pad of porous material in a plastic compartment
And assembled by. The first pad dissolves the antigenic cell components present in the mold cell wall.
Impregnated with releasable reagents. The second pad removes large particles of mold structure.
Made from filter material that can be removed. If necessary,
May cause nonspecific reactions with antibodies used in matographic test sticks
One additional pad containing immobilized antibodies that capture components can be added
. Sample suspension in buffer was pipetted into the lid opening. Within 5 minutes, try
The feed liquid moved along the test strip through the pad for pretreatment. Mold
When the antibody was present, a visible line formed in the test strip
The test was interpreted as positive. In other words, the site examined is the indicator Stachybo
Contaminated by tris chartrum. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 Side view of backing support (1) with lid and lid (2) with hinge (A)
FIG. FIG. 2 shows a closed lid (2) snapped onto a backing support (1) and a positive
Schematic view from above of the test apparatus with the test strip (5) fixed in a new position
is there. FIG. 3 is a sectional side view of a backing support (1) with a lid having an open lid (2).
You. FIG. 4 has an open lid (2) and an opening (3) shown as a round dot or a rounded area.
Pretreatment layers (4.1) and (4.2) and test strips in place
Figure 5 shows a view from above of a backing support (1) with a lid having (5). FIG. 5 is snapped onto the backing support (1) and the pretreatment layers (4.1) and (
4.2) Backing support (1) with lid with lid (2) covering and protecting
FIG. FIG. 6: Transparent closed lid (2) snapped onto the backing support (1)
FIG. 5 is a cross-sectional view as viewed from above, having an opening (3). FIG. 7 has a lid with an open lid (2), no pretreatment layer and no test strip.
It is sectional side view of the backing support (1) obtained. FIG. 8: Lid with open lid (2) without pretreatment layer and without test strip
It is the schematic which looked at the backing support (1) obtained from above. FIG. 9: Lid snapped in place without pretreatment layer and test strip (2
FIG. 2 is a cross-sectional side view of a backing support (1) including a lid having a cover (1). FIG. 10: Transparent closed lid (2) snapped onto backing support (1)
) With no pre-treatment layer and no test strip
is there.

[Procedural amendment] Submission of a translation of the Article 34 Amendment of the Patent Cooperation Treaty [Submission date] November 29, 2001 (2001.1.129) [Procedure amendment 1] [Document name to be amended] Description [Amendment] Subject item] Claims [Correction method] Change [Contents of correction] [Claims] [Claim 1] Equipped with a lid for a test device that performs an assay without separate pretreatment of a sample. A backing support, which is mounted on the backing support (1), covered and protected by a lid (2) having an opening (3) in the lid, said pretreatment system comprising: In one having one or more layers (4) stapled horizontally to one another and assembled with a test strip (5) and a capillary flow connection, the lid and the lid of the backing support with the lid are provided in the pretreatment system. Different sizes and height means a position securing and for securing the (7
, 8 and 9), said means supporting the pretreatment layer (4), preventing the layer (4) from directly resting on the backing support (1) with the lid and the sample solution and diluent (7), which forces the pretreatment layer to pass through the pretreatment layer (4) in a predetermined order before entering the test strip (5), the side preventing the pretreatment layer from moving backwards or laterally Side wall projections to provide supports (8), and can be of different heights and dimensions, to secure the pretreatment layers and to the pretreatment layers (4.1) and (4.2) and the test strip (5) Bar (9) acting as fastening and support means for the
And at least one bar (6) forming a compartment (6) allowing excess sample solution and diluent to be collected behind the pretreatment layer and avoiding a negative backwash effect
9.4) wherein said compartment (6) is controlled by the capillary force of the sample and diluent through and along each layer in and in a subsequent test strip (5) in a predetermined order. Backing support with a lid characterized by being emptied by a uniform flow. 2. Side support for preventing the pre-treatment layer from moving backwards (8.1)
The lid according to claim 1, characterized in that a lid is located in the rear end of the lid of the backing support (1) with the lid, which helps to form a compartment (6) for excess liquid. Backing support provided. 3. A side support (8.2) which prevents the pretreatment layer from moving laterally, simultaneously moves the sample solution and diluent through these layers in a predetermined order, so that they move along the backing support. 2. A backing support with a lid according to claim 1, wherein the backing support is adapted to prevent passage outside the layer. 4. At least one toothed bar (9.3) wherein the means for securing and securing the pretreatment layer secures the connection between the pretreatment layer and the bonding pad (B) of the test strip. The backing support provided with a lid according to claim 1, comprising: 5. The lid according to claim 1, wherein the pretreatment system comprises one or more layers (4) providing physical and / or chemical means for pretreating the sample. Backing support. 6. The lid according to claim 5, wherein the physical means for separating and / or removing components from the sample solution is provided by a filter layer having a variable thickness and dimensions. Backing support provided. 7. The physical means for separating and / or removing components from a sample solution comprises one or more filter layers with shaped pores having different diameters on each side of the filter layer. A backing support provided with the lid according to claim 5. 8. The chemical means for treating the sample solution comprises a buffer, an ionic strength regulator, a flocculant, a disintegrant, an extractant, an immunoacquisition agent, an immune contact agent, a coagulant and / or a lysing agent, and a catalyst. The backing support having a lid according to claim 1, comprising a label, a marker, an enzyme, a substrate, and / or a reagent. 9. A method for performing a quick bedside or field test with a backing support with a lid according to any of claims 1-8, wherein the backing support with the lid is provided in front of the backing support with the lid. In those comprising a treatment layer and a test strip, it comprises the steps: (a) adding a liquid sample through an opening (3) in a lid (2) placed on a pretreatment layer of a backing support with a lid; (B) adding a diluent capable of redissolving the reagent impregnated therein from the pretreatment layer; mixing the sample with the redissolved reagent and driving the sample and reagent mixture through the pretreatment layer, Particles are trapped and interferents are removed in a controlled manner; (c) compartment (6) to allow controlled and uniform flow through the pretreatment layer into the test strip (5) Excess liquid in Collecting; and (d) recording the visible or readable result in a test strip. 10. Use of a backing support with a lid for a test device according to claim 1 for evaluating ferritin from blood. 11. Use of a backing support with a lid for a test device according to any one of claims 1 to 8 for screening for the risk of developing iron deficiency anemia. 12. A method for screening for the presence of environmental pollutants.
Use of a backing support with a lid for a test device according to any of claims 8 to 10.

────────────────────────────────────────────────── ─── Continuation of front page    (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, MZ, SD, SL, SZ, TZ, UG , ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, C A, CH, CN, CR, CU, CZ, DE, DK, DM , DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, K E, KG, KP, KR, KZ, LC, LK, LR, LS , LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, RO, R U, SD, SE, SG, SI, SK, SL, TJ, TM , TR, TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW

Claims (1)

  1. Claims: 1. A test device for performing an assay without a separate pretreatment of a sample, wherein the test device is mounted on a backing support (1) and an opening (3).
    A pre-treatment system covered and protected by a lid (2) having at least one of said pre-treatment systems stapled horizontally to each other and assembled in capillary flow connection with a test strip (5). Wherein the lid and the backing support have means (7, 8 and 9) for securing and fixing the position of the layer in the physical system, said means comprising: The excess fluid collection compartment (6) is formed by a capillary force of the sample and diluent to allow a controlled and uniform flow through each layer and subsequently into the test strip (5) in a predetermined order. A test device characterized by the following: 2. The means for securing and securing the layers of the pretreatment system comprises taps of different heights and dimensions, side supports and bars. 2. The test apparatus according to 1. 3. A tap (7) supporting the pretreatment layer (4) prevents the layer (4) from directly resting on the backing support (1) and allows the sample solution and diluent to enter the test strip (5). 3. The test device according to claim 2, wherein the pretreatment layer (4) is passed through in a previously determined order. 4. The test apparatus according to claim 2, further comprising a wall projection providing a side support which prevents the pretreatment layer from moving backwards or laterally. 5. Side support for preventing the pre-treatment layer from moving backwards (8.1)
    A test device according to claim 4, characterized in that is located in the rear end of the lid of the backing support (1) and helps to create a compartment (6) for excess liquid. 6. A side support (8.2) which prevents the pretreatment layer from moving laterally, simultaneously moves the sample solution and diluent through these layers in a predetermined order, so that they move along the backing support. 5. The test device according to claim 4, wherein the test device is prevented from passing outside the layer. 7. The means for securing and securing the pretreatment layer comprises a bar (9) in the lid and the lid of the backing support, the bar securing the filter layer and the pretreatment layer (4.1). 3.) The test device according to claim 2, which serves as a means for fixing and supporting the test strips (5) and (4.2). 8. The at least one bar (9.4) wherein the means for securing and securing the pretreatment layer forms a compartment (6) for collecting excess sample solution and diluent.
    The test device according to claim 7, wherein the test device is included in a lid portion of the backing support. 9. At least one toothed bar (9.3) wherein the means for securing and securing the pretreatment layer secures the connection between the pretreatment layer and the test strip bonding pad (B). The test apparatus according to claim 7, comprising: 10. The test device according to claim 1, wherein the pretreatment system comprises one or more layers (4) providing physical and / or chemical means for pretreating the sample. 11. The test device according to claim 1, wherein the physical means for separating and / or removing components from the sample solution is provided by a filter layer having a variable thickness and dimensions. . 12. The physical means for separating and / or removing components from a sample solution is provided by one or more filter layers having shaped pores having different diameters on each side of the filter layer. The test apparatus according to claim 1, wherein: 13. The chemical means for treating a sample solution comprises a buffer, an ionic strength regulator, a flocculant, a disintegrant, an extractant, an immunoacquisition agent, an immunocontact agent, a coagulant and / or a lysing agent and a catalyst. The test device according to claim 1, further comprising a label, a marker, an enzyme, a substrate, and / or a reagent. 14. A method for performing a rapid bedside or in-situ test without a separate pretreatment of the sample, comprising the steps of: (a) placing on a backing support (1) of a test device; Opening (3) in lid (2)
    A) adding a liquid sample through the pretreatment layer; and (b) adding a diluent capable of re-dissolving the reagent impregnated therein from the pretreatment layer; mixing the sample with the re-dissolved reagent to prepare the sample and reagent mixture. Drive through the treatment layer, thereby trapping particles and removing interfering substances in a controlled manner; (c) allowing controlled and uniform flow through the pretreatment layer into the test strip (5) Collecting excess liquid in compartment (6) so as to record the visible or readable result in a test strip. 15. Use of the test device according to any one of claims 1 to 12 for evaluating ferritin from blood. 16. Use of the test device according to claim 1 for screening for the risk of developing iron deficiency anemia. 17. Use of the test device according to claim 1 for screening for the presence of environmental pollutants.
JP2001532099A 1999-10-21 2000-10-20 Apparatus with test strip with pretreatment section with lid Pending JP2003512624A (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
FI19992286 1999-10-21
FI992286 1999-10-21
PCT/FI2000/000914 WO2001029558A1 (en) 1999-10-21 2000-10-20 A test strip provided device with a lid-provided pretreatment portion

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JP (1) JP2003512624A (en)
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CN1145796C (en) 2004-04-14
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AU7928600A (en) 2001-04-30
WO2001029558A1 (en) 2001-04-26

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