JPWO2018128749A5

JPWO2018128749A5 -

Info

Publication number: JPWO2018128749A5
Application number: JP2019558334A
Authority: JP
Publication date: 2022-03-08
Anticipated expiration: 2037-12-08

Description

本発明の実施態様は、サンプル内の分析物を試験する方法であって、試験装置のカバーと基部の間に形成された内部空洞内に少なくとも１つのテストストリップを配置すること、前記カバーのサンプリングウェルを通して、前記テストストリップの多孔質領域上に、液体サンプルを導入すること、前記カバ―内に形成された圧縮バーを前記基部内に形成された圧縮クッションに向かって移動させるために、前記試験装置の第１端部上にキャップを摺動させること、この場合に、前記テストストリップの共役パッドが、前記圧縮バーと前記圧縮クッションの間に挟まれている、前記テストストリップの共役パッドを通り、前記液体サンプルを誘導すること、および前記キャップが前記試験装置の前記第１端部上にさらに摺動されるにつれて、前記テストストリップの前記共役パッド上に増大する力をかけることを含む、方法も提供する。 An embodiment of the invention is a method of testing an analyte in a sample, wherein at least one test strip is placed in an internal cavity formed between the cover and the base of the test device, sampling the cover. The test to introduce a liquid sample through the well onto the porous region of the test strip and to move the compression bar formed in the cover towards the compression cushion formed in the base. Sliding the cap onto the first end of the device, in which case the conjugate pad of the test strip passes through the conjugate pad of the test strip sandwiched between the compression bar and the compression cushion. A method comprising guiding the liquid sample and applying an increasing force onto the conjugate pad of the test strip as the cap is further slid onto the first end of the test device. Also provide.

キャップ３４０は、組み立てられた基部３２０とカバー３３０と係合するように、成形し、寸法決めすることができる。
試験装置３５０は、使用前の状態で送達することが可能であり、この場合に、テストストリップ３１０はその中に予め装填され、キャップ３４０は、サンプリングウェル３３２に到達する直前に試験装置３５０の上に保護的に設置される（図２５参照）。
図２６Ａから２６Ｇを参照すると、基部３２０には、テストストリップ３１０をその上に支持するための、１つまたは２つ以上のストリップ支持バー３２２を含めることができる。圧縮クッション３２４は、テストストリップ３１０の共役パッド３１２の位置と一致するように、基部３２０の内側に配置してもよい。サンプル遮断バー３２６は、基部３２０の後端部３２１に配置してもよい。サンプル遮断バー３２６を用いて、サンプルを、圧縮クッション３２４の方へ、したがってテストストリップの共役パッド３１２の方へ向けることができる。カバー３３０をそれに取り付けるために、１つまたは２つ以上のピン穴３２８を、典型的には基部の前端部３２３に向けて配置してもよい。 The cap 340 can be molded and dimensioned to engage the assembled base 320 and cover 330.
The test device 350 can be delivered in a pre-use state, in which case the test strip 310 is preloaded therein and the cap 340 is placed on the test device 350 just before reaching the sampling well 332. It is installed in a protective manner (see FIG. 25).
Referring to FIGS. 26A-26G, the base 320 may include one or more strip support bars 322 for supporting the test strip 310 on it. The compression cushion 324 may be placed inside the base 320 so as to coincide with the position of the conjugate pad 312 of the test strip 310. The sample blocking bar 326 may be located at the rear end portion 321 of the base portion 320. The sample blocking bar 326 can be used to direct the sample towards the compression cushion 324 and thus towards the conjugate pad 312 of the test strip. One or more pin holes 328 may be arranged towards the front end 323 of the base to attach the cover 330 to it.

図２７Ａから２７Ｇを参照すると、カバー３３０には、その中にサンプルを受け入れるための、サンプリングウェル３３２を含めることができる。サンプルがサンプリングウェル３３２に導入されるとき、サンプルは、テストストリップ３１０の多孔質材料３１７と流体接触する。実施態様によっては、サンプリングパッド（図示せず）を、サンプリングウェル３３２に組み込んで、サンプリングウェル３３２を通して導入されたサンプルを吸収的に受け取ることができる。サンプリングウェル３３２は、カバー３３０の前端部３３３とは反対側の後端部３３１に隣接して配置してもよい。 Referring to FIGS. 27A-27G, the cover 330 may include a sampling well 332 for receiving the sample therein. When the sample is introduced into the sampling well 332, the sample is in fluid contact with the porous material 317 of the test strip 310. In some embodiments, a sampling pad (not shown) can be incorporated into the sampling well 332 to absorb the sample introduced through the sampling well 332. The sampling well 332 may be arranged adjacent to the rear end portion 331 opposite to the front end portion 333 of the cover 330.

次に、図２６～２９を参照すると、カバー３３０には、基部３２０の圧縮クッション３２４と整列する圧縮バー３３４を含めることができる。テストストリップ３１０の共役パッド３１２は、組み立てられた試験装置３５０において、圧縮バー３３４と圧縮クッション３２４の間に配置してもよい。
試験装置の使用中に、サンプルをサンプリングウェル３３２内に配置して、サンプルをテストストリップの多孔質部分３１７に接触させてもよい。キャップ３４０は、組み立てられた基部３２０およびカバー３３０の後端部３２１、３３１の上を摺動させてもよい。 Next, referring to FIGS. 26-29, the cover 330 may include a compression bar 334 aligned with the compression cushion 324 of the base 320. The conjugate pad 312 of the test strip 310 may be placed between the compression bar 334 and the compression cushion 324 in the assembled test apparatus 350.
During use of the test device, the sample may be placed in the sampling well 332 to bring the sample into contact with the porous portion 317 of the test strip. The cap 340 may slide over the assembled base 320 and the rear ends 321 and 331 of the cover 330.

Claims

A device that tests a liquid sample for the concentration of at least one analyte.
With the cover,
A base that connects the internal cavity to the upper end member that forms therein, which is configured to receive the test strip.
The compression bar formed in the cover and
A compression cushion formed in the base, wherein when the test strip is placed in the internal cavity, the compression bar and the compression cushion are configured to sandwich the conjugate pad of the test strip. With a cushion,
A cap that fits over the first end of the device and is configured to press the compression bar of the cover against the compression cushion, thereby driving the liquid sample along the test strip during the test. A device that is equipped with a cap.

The device of claim 1, wherein the interior of the cap comprises at least one ramp that produces an increasing force on the cover when the cap is slidably engaged onto the first end. ..

The device of claim 1, further comprising a window formed on at least one of a cover and a base.

A sample well formed within a cover, further comprising a sample well that allows a liquid sample to be introduced onto the test strip when the test strip is placed in the internal voids, claim 1. The device described in.

A sample blocking bar placed within the base, when the liquid sample is placed within the porous region of the test strip and the cap is slidably engaged onto the first end of the device. The device of claim 1, further comprising a sample blocking bar that prevents the sample from moving towards the first end of the device.

A mounting mechanism that joins the cover to the base, further comprising a mounting member located adjacent to the second end of the device, opposite the first end, wherein the cover is the said of the device. The device of claim 1, wherein at the first end, it is possible to bend towards the base.

The device of claim 1, further comprising a vent window that allows air exchange with the internal cavity of the device.

A test system that tests liquid samples for the concentration of at least one analyte.
Conjugated pads containing a source of mobile, labeled first affinity binding members capable of binding to the analyte, and immobilized second affinity capture binding members capable of binding to said analyte. Containing, including, including at least one strip line, including a liquid permeable reaction region,
With at least one test strip,
cover,
A base that connects the internal cavity to the upper end member that forms it, which houses the test strip.
A compression bar formed in the cover,
A compression cushion formed within the base, wherein the compression bar and compression cushion are a compression cushion that sandwiches a conjugate pad of the test strip, and a cap that fits onto the first end of the device. A cap is provided that presses the compression bar of the cover against the compression cushion, thereby driving the liquid sample along the test strip during the test.
A test system equipped with a test device.

8. The test of claim 8, wherein the interior of the cap comprises at least one ramp that produces an increasing force on the cover when the cap is slidably engaged onto the first end. system.

The test system of claim 8, further comprising a window formed on at least one of a cover and a base.

8. A sample well formed within a cover, further comprising a sample well that allows a liquid sample to be introduced onto the test strip when the test strip is placed in the internal voids. The test system described.

A sample blocking bar placed within the base, when the liquid sample is placed within the porous region of the test strip and the cap is slidably engaged onto the first end of the device. The test system of claim 8, further comprising a sample cutoff bar that prevents the sample from moving towards the first end of the device.

A mounting mechanism that joins the cover to the base, further comprising a mounting member located adjacent to the second end of the device, opposite the first end, wherein the cover is the first of the device. The test system of claim 8, wherein at one end it is possible to bend towards the base.

The test system of claim 8, further comprising a vent window that allows air exchange with the internal cavity of the device.

A method of testing an analyte in a sample,
Placing at least one test strip in the internal cavity formed between the cover and base of the test device,
Introducing a liquid sample over the porous area of the test strip through the sampling wells of the cover.
Sliding the cap onto the first end of the test device to move the compression bar formed in the cover towards the compression cushion formed in the base, in this case the test. The conjugate pad of the strip is sandwiched between the compression bar and the compression cushion,
As the liquid sample is guided through the conjugate pad of the test strip and the cap is further slid onto the first end of the test device, it builds up onto the conjugate pad of the test strip. Methods, including exerting force.

15. The test system of claim 15, wherein the test results are read through a window formed in at least one of the cover and the base.

15. The test system of claim 15, further comprising preventing the liquid sample from moving towards the first end of the test device with a barrier bar located within the base.

It further comprises coupling the cover to the base by a mounting mechanism located adjacent to the second end of the device on the opposite side of the first end, wherein the cover is at the first end of the device. 15. The test method of claim 15, which can bend towards the base.