JPWO2022060415A5 - - Google Patents

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JPWO2022060415A5
JPWO2022060415A5 JP2023517379A JP2023517379A JPWO2022060415A5 JP WO2022060415 A5 JPWO2022060415 A5 JP WO2022060415A5 JP 2023517379 A JP2023517379 A JP 2023517379A JP 2023517379 A JP2023517379 A JP 2023517379A JP WO2022060415 A5 JPWO2022060415 A5 JP WO2022060415A5
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Priority claimed from PCT/US2021/025789 external-priority patent/WO2022060415A1/en
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診断試験キットであって、
試験結果を示すための試験領域を含む診断試験と、
１又は２以上のコントロールマーキングを含むスキャン面と、
を備え、前記１又は２以上のコントロールマーキングは、前記診断試験に関する１又は２以上の所定の試験結果を表す、診断試験キット。 1. A diagnostic test kit comprising:
a diagnostic test including a test area for indicating a test result;
a scan surface including one or more control markings;
wherein said one or more control markings indicate one or more predetermined test results for said diagnostic test. 前記診断試験が、ラテラルフローイムノアッセイ試験を含み、前記１又は２以上のコントロールマーキングが、１又は２以上のラインを含む、請求項１に記載の診断試験キット。 10. The diagnostic test kit of claim 1 , wherein the diagnostic test comprises a lateral flow immunoassay test and the one or more control markings comprise one or more lines. 前記１又は２以上のラインは太さが異なる、請求項２に記載の診断試験キット。 3. The diagnostic test kit of claim 2 , wherein said one or more lines vary in thickness. 前記１又は２以上のラインは色が異なる、請求項２に記載の診断試験キット。 3. The diagnostic test kit of claim 2 , wherein said one or more lines are of different colors. 前記１又は２以上のラインは色相が異なる、請求項２に記載の診断試験キット。 3. The diagnostic test kit of claim 2 , wherein said one or more lines are of different hues. 前記１又は２以上のラインは反射率が異なる、請求項２に記載の診断試験キット。 3. The diagnostic test kit of claim 2 , wherein said one or more lines have different reflectances. 前記１又は２以上のラインは、黒色及び／又は灰色である、請求項２に記載の診断試験キット。 3. The diagnostic test kit of claim 2 , wherein said one or more lines are black and/or gray. 前記１又は２以上のラインは、前記診断試験における試験結果ラインの予想される色に一致する色である、請求項２に記載の診断試験キット。 3. The diagnostic test kit of claim 2 , wherein said one or more lines are a color that corresponds to an expected color of a test result line in said diagnostic test. 前記診断試験が、比色イムノアッセイ試験を含み、前記１又は２以上のコントロールマーキングが、複数の色を含む、請求項１に記載の診断試験キット。 10. The diagnostic test kit of claim 1 , wherein the diagnostic test comprises a colorimetric immunoassay test and the one or more control markings comprise a plurality of colors. 前記１又は２以上のコントロールマーキングは、前記スキャン面上に印刷される、請求項１に記載の診断試験キット。 The diagnostic test kit of claim 1 , wherein the one or more control markings are printed on the scan surface. 前記１又は２以上のコントロールマーキングは、インク又はトナーで印刷される、請求項１０に記載の診断試験キット。 11. The diagnostic test kit of claim 10 , wherein said one or more control markings are printed with ink or toner. 前記１又は２以上のコントロールマーキングは、蛍光インクで印刷されている、請求項１１に記載の診断試験キット。 12. The diagnostic test kit of claim 11 , wherein said one or more control markings are printed with fluorescent ink. 前記蛍光インクが、ユーロピウム、ローダミン、フルオレセイン、アレキサフルオロ、量子ドット、及び蛍光ナノ粒子からなる群から選択される少なくとも１つを含む、請求項１２に記載の診断試験キット。 13. The diagnostic test kit of claim 12 , wherein the fluorescent ink comprises at least one selected from the group consisting of europium, rhodamine, fluorescein, alexafluor, quantum dots, and fluorescent nanoparticles. 前記スキャン面が更に、１又は２以上のコントロールマーキングに近接した試験配置ガイドを備え、前記試験配置ガイドが、前記診断試験の配置をガイドするように構成される、請求項１に記載の診断試験キット。 10. The diagnostic test kit of claim 1 , wherein the scan surface further comprises a test placement guide adjacent one or more control markings, the test placement guide configured to guide placement of the diagnostic test. 前記スキャン面が第１のスキャン面であり、前記診断試験キットが更に、第１のスキャン面とは別の第２のスキャン面を備え且つ試験配置ガイドを含む、請求項１に記載の診断試験キット。 2. The diagnostic test kit of claim 1 , wherein said scan plane is a first scan plane, said diagnostic test kit further comprising a second scan plane separate from the first scan plane and including a test placement guide. 加熱デバイスを更に備える、請求項１に記載の診断試験キット。 The diagnostic test kit of claim 1 further comprising a heating device. 前記加熱デバイスと前記加熱デバイスに近接した試験配置ガイドとを含むハウジングを更に備え、前記試験配置ガイドは、前記診断試験の配置をガイドするように構成される、請求項１６に記載の診断試験キット。 17. The diagnostic test kit of claim 16 , further comprising a housing containing the heating device and a test placement guide proximate to the heating device, the test placement guide configured to guide placement of the diagnostic test. 前記スキャン面が、前記ハウジング上に配置される、請求項１７に記載の診断試験キット。 The diagnostic test kit of claim 17 , wherein the scan surface is disposed on the housing. 前記ハウジングが、診断試験サンプルを受け入れるように構成されている、請求項１８に記載の診断試験キット。 20. The diagnostic test kit of claim 18 , wherein the housing is configured to receive a diagnostic test sample. 前記ハウジングが、試験サンプル容器を受け入れるように構成されたレセプタクルを備える、請求項１９に記載の診断試験キット。 20. The diagnostic test kit of claim 19 , wherein the housing comprises a receptacle configured to receive a test sample container. 前記レセプタクルが、前記加熱デバイスに近接している、請求項２０に記載の診断試験キット。 21. The diagnostic test kit of claim 20 , wherein the receptacle is adjacent to the heating device. 前記少なくとも１つのラインが、太さ、強度、色又は色相の異なる複数のラインを含む、請求項２に記載の診断試験キット。3. The diagnostic test kit of claim 2, wherein the at least one line comprises a plurality of lines of different thickness, intensity, color or hue. 前記複数のラインの少なくとも１つの大きさ、形状、強度、及び／又は色が、コントロールライン又は前記診断試験の試験ラインの予想される太さ、強度、又は色と類似している、請求項２２に記載の診断試験キット。23. The diagnostic test kit of claim 22, wherein the size, shape, intensity, and/or color of at least one of the plurality of lines is similar to the expected thickness, intensity, or color of a control line or a test line of the diagnostic test. 前記スキャン面が１つ以上の空間マーカをさらに含む、請求項１に記載の診断試験キット。The diagnostic test kit of claim 1 , wherein the scan plane further comprises one or more spatial markers. 前記１つ以上の空間マーカは、前記試験領域の部分を含む前記画像の領域を境界付ける３つ以上の空間マーカのセットを含む、請求項２４に記載の診断試験キット。25. The diagnostic test kit of claim 24, wherein the one or more spatial markers comprise a set of three or more spatial markers that bound an area of the image that includes a portion of the test area. 前記診断試験及び前記スキャン面を描写する画像を受信し、前記画像の品質を確認するように、１つ以上のプロセッサ上で実行可能なコンピュータアプリケーションをさらに含む、請求項１に記載の診断試験キット。10. The diagnostic test kit of claim 1, further comprising a computer application executable on one or more processors to receive images depicting the diagnostic test and the scan plane and verify a quality of the images. 前記画像の品質を確認することは、Ascertaining the quality of the image
画素値の１次元（１Ｄ）アレイを生成することと、generating a one-dimensional (1D) array of pixel values;
前記画素値の１次元アレイの個々の要素を分析して、前記画像中の前記コントロールマーキングに対応する一連のピークを決定することと、を含む、and analysing individual elements of the one-dimensional array of pixel values to determine a series of peaks corresponding to the control markings in the image.
請求項２６に記載の診断試験キット。27. The diagnostic test kit of claim 26. 画素値の前記１次元アレイの個々の要素は、前記受信した画像の画像セグメントの代表指標である、請求項２７に記載の診断試験キット。28. The diagnostic test kit of claim 27, wherein each element of said one-dimensional array of pixel values is a representative index of an image segment of said received image. 前記代表指標は、前記画像の画素の行又は列の統計指標を含む、請求項２８に記載の診断試験キット。30. The diagnostic test kit of claim 28, wherein the representative index comprises a statistical index of rows or columns of pixels of the image. 前記画像の品質を確認することは、前記決定された一連のピークのカウントを所定値と比較することをさらに含む、請求項２７に記載の診断試験キット。30. The diagnostic test kit of claim 27, wherein verifying the quality of the image further comprises comparing the determined set of peak counts to a predetermined value. 前記スキャン面は、識別情報を有する少なくとも１つのコンピュータ可読コードをさらに含む、請求項１に記載の診断試験キット。The diagnostic test kit of claim 1 , wherein the scan surface further comprises at least one computer readable code having identifying information. 診断試験を分析するための方法であって、
１又は２以上のプロセッサにおいて、
診断試験を描写する画像を受信するステップであって、前記診断試験は、試験結果を示す試験領域を含む、ステップと、
前記画像の品質を確認するステップと、
前記診断試験の前記試験領域を描写している前記画像の試験領域画像部分を位置特定するステップと、
前記試験領域画像部分に基づいて前記試験結果を予測するステップと、
を含む、方法。 1. A method for analyzing a diagnostic test, comprising:
In one or more processors,
receiving an image depicting a diagnostic test, the diagnostic test including a test area indicating a test result;
checking the quality of the image;
locating a test area image portion of the image depicting the test area of the diagnostic test;
predicting the test result based on the test area image portion;
A method comprising: 前記画像の品質を確認するステップが、前記受信した画像における照明レベル、カラーバランス、ノイズレベル、画像ボケレベル、影の存在、及びグレアの存在のうちの少なくとも１つを評価するステップを含む、請求項３２に記載の方法。 33. The method of claim 32, wherein verifying the image quality comprises evaluating at least one of the following in the received image: illumination level, color balance, noise level, image blur level, presence of shadows, and presence of glare. 前記画像の品質を確認するステップが、前記受信した画像における診断試験の位置及び方向のうちの少なくとも１つを評価するステップを含む、請求項３２に記載の方法。 33. The method of claim 32 , wherein verifying the image quality comprises evaluating at least one of a position and an orientation of a diagnostic test in the received image. 前記画像の品質を確認するステップが、前記受信した画像における１又は２以上のコントロールマーキングの画像化品質を確認するステップを含む、請求項３２に記載の方法。 33. The method of claim 32 , wherein verifying the quality of the image comprises verifying an imaging quality of one or more control markings in the received image. 前記１又は２以上のコントロールマーキングが、複数のラインを含む、請求項３５に記載の方法。 36. The method of claim 35 , wherein the one or more control markings comprise a plurality of lines. 前記１又は２以上のコントロールマーキングが、複数の色を含む、請求項３５に記載の方法。 36. The method of claim 35 , wherein the one or more control markings comprise a plurality of colors. 前記試験領域画像部分を位置特定するステップが、前記画像における前記診断試験の境界を特定するステップを含む、請求項３２に記載の方法。 33. The method of claim 32 , wherein locating the test area image portion comprises identifying a boundary of the diagnostic test in the image. 前記画像における前記診断試験の境界を特定するステップが、高コントラストの背景に対して前記診断試験の境界を特定するステップを含む、請求項３８に記載の方法。 40. The method of claim 38 , wherein identifying a boundary of the diagnostic test in the image comprises identifying a boundary of the diagnostic test against a high contrast background. 前記試験領域画像部分を位置特定するステップが、前記画像における前記診断試験の境界に対する１又は２以上の所定の試験領域座標に少なくとも部分的に基づいて、前記試験領域画像部分を位置特定するステップを含む、請求項３８に記載の方法。 39. The method of claim 38, wherein locating the test area image portion comprises locating the test area image portion based at least in part on one or more predetermined test area coordinates relative to a boundary of the diagnostic test in the image. 前記１又は２以上の所定の試験領域座標は、前記診断試験のタイプと関連付けられている、請求項４０に記載の方法。 41. The method of claim 40 , wherein the one or more predefined test area coordinates are associated with a type of the diagnostic test. 前記試験領域画像部分を位置特定するステップが、前記画像におけるスキャン面上に１又は２以上のフィデューシャルを特定するステップと、前記１又は２以上のフィデューシャルの位置に基づいて前記試験領域画像部分を位置特定するステップとを含む、請求項３２記載の方法。 33. The method of claim 32, wherein locating the test area image portion comprises: identifying one or more fiducials on a scan plane in the image; and locating the test area image portion based on the positions of the one or more fiducials. 前記試験領域画像部分を位置特定するステップが、前記画像における所定のカラーチャンネルのピーク代表値を有する関心画像部分を特定するステップと、前記関心画像部分における所定のカラーチャンネルの最大輪郭の位置に基づいて前記試験領域画像部分を位置特定するステップとを含む、請求項３２に記載の方法。 33. The method of claim 32, wherein locating the test area image portion comprises: identifying an image portion of interest having a peak representative value of a given color channel in the image; and locating the test area image portion based on a position of a maximum contour of the given color channel in the image portion of interest. 前記所定のカラーチャンネルは、ＬＡＢ、ＹＵＶ、ＨＳＶ、ＸＹＺ、及びＣＹＭＫからなる群から選択される色空間内にある、請求項４３に記載の方法。 44. The method of claim 43 , wherein the predetermined color channel is in a color space selected from the group consisting of LAB, YUV, HSV, XYZ, and CYMK. 前記試験結果を予測するステップが、前記試験領域画像部分における所定のカラーチャンネル内の１又は２以上のピークプロミネンスを特定するステップを含む、請求項３２に記載の方法。 33. The method of claim 32 , wherein predicting the test outcome comprises identifying one or more peak prominences in predetermined color channels in the test area image portion. 前記試験結果を予測するステップが、前記試験領域画像部分におけるコントロール及び結果インジケータの少なくとも１つについて、前記１又は２以上のピークプロミネンスを評価するステップを含む、請求項４５に記載の方法。 46. The method of claim 45 , wherein predicting the test outcome comprises evaluating the one or more peak prominences for at least one of a control and a result indicator in the test area image portion. ユーザの１又は２以上の画像を受信するステップと、前記ユーザの前記１又は２以上の画像に基づいて前記ユーザによりサンプル採取を検証するステップとを更に含む、請求項３２に記載の方法。 33. The method of claim 32 , further comprising receiving one or more images of a user; and verifying sample collection by the user based on the one or more images of the user. 前記受信した画像に描かれた前記診断試験のタイプを特定するステップを更に含む、請求項３２に記載の方法。 33. The method of claim 32 , further comprising identifying the type of diagnostic test depicted in the received image. 前記予測された試験結果をユーザに伝達するステップを更に含む、請求項３２に記載の方法。 33. The method of claim 32 , further comprising the step of communicating the predicted test results to a user. 前記診断試験が、ラテラルフローイムノアッセイ試験を含む、請求項３２に記載の方法。 33. The method of claim 32 , wherein the diagnostic test comprises a lateral flow immunoassay test. 前記ラテラルフローイムノアッセイ試験が、ダイレクトフローイムノアッセイ試験である、請求項５０に記載の方法。 51. The method of claim 50 , wherein the lateral flow immunoassay test is a direct flow immunoassay test. 前記診断試験が、比色イムノアッセイ試験を含む、請求項３２記載の方法。 33. The method of claim 32 , wherein the diagnostic test comprises a colorimetric immunoassay test. 前記比色イムノアッセイ試験が、等温増幅試験である、請求項５２記載の方法。 53. The method of claim 52 , wherein the colorimetric immunoassay test is an isothermal amplification test. 前記複数のラインの少なくとも１つの大きさ、形状、強度、及び／又は色が、コントロールライン又は前記診断試験の試験ラインの予想される太さ、強度、又は色と類似している、請求項３６に記載の方法。37. The method of claim 36, wherein the size, shape, intensity, and/or color of at least one of the plurality of lines is similar to the expected thickness, intensity, or color of a control line or a test line of the diagnostic test. 前記試験領域画像部分を含む前記画像の領域を境界付ける３つ以上の空間マーカのセットを特定するステップ含む、請求項３２に記載の方法。33. The method of claim 32, comprising identifying a set of three or more spatial markers that bound a region of the image that includes the test area image portion. 前記画像の品質を確認するステップは、The step of checking the quality of the image includes:
画素値の１次元（１Ｄ）アレイを生成するステップと、generating a one-dimensional (1D) array of pixel values;
前記画素値の１次元アレイの個々の要素を分析して、前記画像中のコントロールマーキングに対応する一連のピークを決定するステップと、を含む、and analysing individual elements of the one-dimensional array of pixel values to determine a series of peaks corresponding to control markings in the image.
請求項３２に記載の方法。33. The method of claim 32. 画素値の前記１次元アレイの個々の要素は、前記受信した画像の画像セグメントの代表指標である、請求項５６に記載の方法。57. The method of claim 56, wherein each element of the one-dimensional array of pixel values is a representative index of an image segment of the received image. 前記代表指標は、前記受信した画像の画素の行又は列の統計指標を含む、請求項５７に記載の方法。58. The method of claim 57, wherein the representative measure comprises a statistical measure of rows or columns of pixels of the received image. 前記画像の品質を確認するステップは、前記決定された一連のピークのカウントを所定値と比較するステップをさらに含む、請求項５６に記載の方法。57. The method of claim 56, wherein verifying the quality of the image further comprises comparing the determined count of the set of peaks to a predetermined value. 前記画像の品質を確認するステップは、前記画像における前記１又は２以上のコントロールマーキングの検出を検証するステップを含む、請求項３２に記載の方法。33. The method of claim 32, wherein verifying the quality of the image comprises verifying detection of the one or more control markings in the image. 前記１又は２以上のコントロールマーキングの検出に失敗したことに応答してユーザに通知するステップをさらに含む、請求項６０に記載の方法。61. The method of claim 60, further comprising the step of notifying a user in response to failing to detect the one or more control markings. 前記１又は２以上のコントロールマーキングの検出を検証するステップは、前記画像における白色空間をネガティブコントロールとして処理するステップを含む、請求項６０に記載の方法。61. The method of claim 60, wherein verifying detection of the one or more control markings comprises treating white spaces in the image as a negative control.
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