TW515886B - Eliminating interference membranes containing compound having mercapto, and test strips, kits and methods for use in uric acid assay - Google Patents

Eliminating interference membranes containing compound having mercapto, and test strips, kits and methods for use in uric acid assay Download PDF

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Publication number
TW515886B
TW515886B TW88107229A TW88107229A TW515886B TW 515886 B TW515886 B TW 515886B TW 88107229 A TW88107229 A TW 88107229A TW 88107229 A TW88107229 A TW 88107229A TW 515886 B TW515886 B TW 515886B
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patent application
item
uric acid
test
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TW88107229A
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Chinese (zh)
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Yi-Fen Tsai
Liang-Yin Liou
Shiue-Fen Chen
Tai-Guang Wu
Jiuan Liou
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Dev Center Biotechnology
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Abstract

The present invention provides an eliminating-interference membrane for use in detecting uric acid in a sample, comprising a compound for shading uric acid interfering substances or derivatives thereof and a carrier having absorption and permeability of the sample. The present invention further provides a test strip for use in detecting uric acid in a sample, comprising a test reagent layer and an optional eliminating-interference membrane and/or support layer. The present invention also provides a kit for use in detecting uric acid in a sample, comprising the test strip of the invention.

Description

515886 A7 B7 五、發明説明(l 發明領域 本發明係關於用於檢測檢體中尿酸之去 π 丁镘膜、檢驗詰 片、組件及方法。- 發明背景 血清及其它體液等檢體中尿酸之檢測係用以醫學界診斷 與監測不同病況期間之工具之一。例如,當血中尿酸=有 異常高濃度時,頃向在身體關節中晶析出,因而引起非常 疼痛兄疫病況,稱為痛風。亦知向尿酸血含量與尿毒症及 白血球之細胞核大量破壞之病症(如白血病及肺炎)有關。 由於血清與尿液中有許多物質(例如抗壞血酸)在一般檢 驗方法中可能誤判為尿酸,且若將誤判之高量尿酸告知醫 生,則病患可能被誤施以潛在危險、昂貴、不適當或不必 要之治療。是以,尿酸之正確測量不易達成,但有其必 要。 經濟部智慧財產局8工消費合作社印製 已有數種不同方式決定尿酸。最常用之兩種方法係化學 法及酵素法。在化學法中,已知以還原驗性磷酸鶏鹽成鶴 藍(見W0 83/01513 )或還原形成深紫色Cu(I) - 2,2,-二辛可寧 (bicinchoninate,BCA)螫合物(Gindle EM·,Clin. Chem 1970; 16:536) 可以檢測尿酸。惟該等方法常遭遇檢體中干擾物質(如抗壞 血酸)干擾,造成專一性不佳,是以,在1980至1990年代, 醫院逐漸採用酵素法代替化學法來檢測尿酸。 酵素法係採用尿酸在290-293 MM吸收光之性質。尿酸酶 反應產物在此波長時並不吸收。於是藉吸光度減少與最初 尿酸存在量成正比而檢測尿酸。雖然,酵素法之專一性相 本纸張尺度適用中國國家標準(CNS ) A4規格(210X 297公楚) 515886 A7 B7 五、發明説明(2 當向’然而尿酸酶常雲 而相關人貝頭外注意才能維持稃定 =二用酵素法檢驗費用較化學法昂貴。而由於酶本 、'、 ’在料上不若化學法之試劑方便。是以,酵 素:仍需在特定場所(如醫院或檢驗所)進行,而無法普及 居永使用。 wo醜513揭示以加入某些含酸基化合物於驗性鱗酸鎮 _與檢體之混合物用於檢測檢體中尿酸。然而該案所 知π祆驗過私仍需要在檢驗前配製與混合試劑。對一般使 用者仍不便利。 一種兼具向專一性及穩定性之尿酸檢驗試劑,可便利用 於居家中自行檢驗尿酸且可依試劑本身顏色變化讓非專業 人士(如病患)判謂尿酸之含量,當屬必須。 發明之概述 本發明之目的係提供一種用於檢測檢體中尿酸之去干擾 膜。 本發明之另一目的係提供一種用於檢測檢體中尿酸之檢 驗試片。 經濟部智慈財產局員工消骨合作社印製 本發明之又一目的係提供一種檢測檢體中尿酸之組件。 本發明之進一目的係提供一種檢測檢體中尿酸之方法。 本發明之目的、優點及特徵可由下列之説明而更為明 瞭。 圖式簡單說明 圖1代表不含去干擾膜之檢驗試片。 圖2代表含去干擾膜之檢驗試片。 一 5 - 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 5l5886 A7 _ B7__ 五、發明説明(3 ) 圖3代表於無去干擾膜及不同濃度抗壞血酸(AA)與半脱胺 酸存在下對尿酸(UA)之判讀結果,其中Y軸代表波長557nm 之反射值(Y值)。- 圖4代表含去干擾膜及不同濃度抗壞血酸(AA)與半耽胺酸 存在下對尿酸(UA)之判讀結果,其中Y軸代表波長557nm之 反射值(Y值)。 圖5代表酵素法與本發明方法之相關性。 代表符號 圖1及2中各符號代表意義如下: 1〇代表撐體層, 15代表孔洞, 20代表試劑反應層, 30代表去干擾膜, 40代表檢驗試片。 發明之詳細說曰& 文中n遮蔽尿酸檢測干擾物之化合物或其衍生物,,係針對 所有適用於遮蔽尿酸檢測干擾物之化合物或其衍生物,主 要係含筑基之化合物或其衍生物,較佳者係半胱胺酸或穀 胱甘肽,最佳者係半胱胺酸。 是以’本發明首係關於一種用於檢測檢體中尿酸之去干 擾膜’包括遮蔽尿酸檢測干擾物之化合物或其衍生物及具 有檢體吸收通透性之載體。 去干擾膜中所用載體係能負載檢體並讓檢體至試劑反應 層之材質’較佳者係不織布、濾紙、硝化纖維膜、耐龍膜 -6 - 本^^度適财晒家標?—- (請先閲讀背面之注意事項再^^本頁) 衣· 本515886 A7 B7 V. Description of the Invention (1) Field of the Invention The present invention relates to a π-butadiene film, a test diaphragm, a component and a method for detecting uric acid in a specimen.-BACKGROUND OF THE INVENTION Detection is one of the tools used by the medical community to diagnose and monitor different conditions. For example, when the blood uric acid = abnormally high concentration, it is precipitated in the joints of the body, which causes a very painful brotherhood disease condition, called gout. .It is also known that the blood content of uric acid is related to uremia and a large number of nucleus destruction of white blood cells (such as leukemia and pneumonia). Because there are many substances in serum and urine (such as ascorbic acid) may be misjudged as uric acid in general testing methods, If a doctor is informed of a falsely high amount of uric acid, the patient may be mistaken for potentially dangerous, expensive, inappropriate or unnecessary treatment. Therefore, the correct measurement of uric acid is not easy to achieve, but it is necessary. Intellectual Property of the Ministry of Economic Affairs The Bureau 8 Industrial Cooperative Cooperative has printed several different ways to determine uric acid. The two most commonly used methods are the chemical method and the enzyme method. In the method, it is known to reduce the authentic phosphonium phosphonium salt into crane blue (see WO 83/01513) or reduce to form a dark purple Cu (I)-2,2, -bicinchoninate (BCA) complex ( Gindle EM ·, Clin. Chem 1970; 16: 536) can detect uric acid. However, these methods often encounter interference from interfering substances (such as ascorbic acid) in the specimen, resulting in poor specificity. Therefore, in the 1980s to 1990s, hospitals The enzyme method is gradually used instead of the chemical method to detect uric acid. The enzyme method uses the property of uric acid to absorb light at 290-293 MM. The uric acid reaction product does not absorb at this wavelength. Therefore, the decrease in absorbance is directly proportional to the initial amount of uric acid. Detection of uric acid. Although the specificity of the enzyme method is based on the Chinese paper standard (CNS) A4 (210X 297), 515886 A7 B7 V. Description of the invention (2 When the uric acid is often clouded and related human shellfish Attention can be maintained outside the head = the use of the enzyme method is more expensive than the chemical method. Because the enzyme, ',' are not as convenient as the reagents of the chemical method. Therefore, the enzyme: still needs to be in a specific place (such as Hospital or laboratory ), But can not be universally used by Juyong. WO 513 revealed that the addition of certain acid-containing compounds to the test phosphonic acid _ and the sample mixture for the detection of uric acid in the sample. However, the case is known π test It is still necessary to prepare and mix reagents before testing. It is still inconvenient for ordinary users. A uric acid test reagent with specificity and stability can be used to test uric acid at home and can be changed according to the color of the reagent itself It is necessary for a non-professional person (such as a patient) to judge the content of uric acid. SUMMARY OF THE INVENTION The object of the present invention is to provide an anti-interference film for detecting uric acid in a specimen. Another object of the present invention is to provide a Test strip for detecting uric acid in a specimen. Printed by the bone-eliminating cooperative of the Intellectual Property Office of the Ministry of Economic Affairs Another object of the present invention is to provide a component for detecting uric acid in a specimen. A further object of the present invention is to provide a method for detecting uric acid in a specimen. The objects, advantages and features of the present invention will be made clearer by the following description. Brief description of the drawings Figure 1 represents the test piece without interference film. Fig. 2 represents a test piece containing an anti-interference film. 5-This paper size applies Chinese National Standard (CNS) A4 specification (210X297 mm) 5l5886 A7 _ B7__ V. Description of the invention (3) Figure 3 represents the non-interference film and different concentrations of ascorbic acid (AA) and semi-deaminated The interpretation of uric acid (UA) in the presence of acid, where the Y axis represents the reflection value (Y value) at a wavelength of 557 nm. -Figure 4 represents the interpretation of uric acid (UA) in the presence of an anti-interference film and different concentrations of ascorbic acid (AA) and hemamic acid, where the Y axis represents the reflection value (Y value) at a wavelength of 557 nm. Figure 5 represents the correlation between the enzyme method and the method of the invention. Representative symbols The meanings of the symbols in Figures 1 and 2 are as follows: 10 represents the support layer, 15 represents the hole, 20 represents the reagent reaction layer, 30 represents the anti-interference film, and 40 represents the test piece. Detailed description of the invention & In the text, n compounds or their derivatives covering uric acid detection interfering substances are for all compounds or their derivatives suitable for shielding uric acid detecting interfering substances, mainly compounds or derivatives containing building blocks The better one is cysteine or glutathione, and the best one is cysteine. The first aspect of the present invention is a desiccant film for detecting uric acid in a sample, which includes a compound or a derivative thereof that shields the interference of uric acid detection, and a carrier having permeability of the sample. The carrier used in the anti-interference film is a material that can support the specimen and allow the specimen to the reagent reaction layer. 'The better one is non-woven fabric, filter paper, nitrocellulose membrane, and resistant film. —- (Please read the precautions on the back before ^^ this page)

、1T 經濟部智慧財產局員工消費合作社印製 515886 A7 B7 五、發明説明(4 ) 2f先閑讀' 背面之_事項再本頁 及玻璃纖維,最佳者係不織布。載體之顏色未特別限定但 以不影響試劑反應之顏色為主,較佳者呈淺色或白色,最 佳者呈白色。 - 本發明另係關於一種用於檢測檢體中尿酸之檢驗試片, 包括一試劑反應層,其包括試劑與載體,其中試劑係含鋼 離子(Cu2+)、二辛可寧酸鹽(bicinch〇ninate,BCA)及避免銅離子 與二辛可寧酸鹽產生沉澱物之化合物或其衍生物。 本發明之檢驗試片另視需要包括去干擾膜,其位於試劑 反應層上方,包括遮蔽尿酸檢測干擾物之化合物或其衍生 物及具有檢體吸收通透性之載體。 本發明之檢驗試片另視需要包括撐體層或稱背板,其位 訂 於試劑反應層下方且視需要於檢測檢體對應位置上開一孔 洞。琢撐體層係支撐試劑反應層與去干擾膜之材質,較佳 為塑膠材質。 經濟部智慧財產局員工消f合作社印製 試劑中銅離子係來自能提供銅離子之化合物或其衍生 物,較佳者係硫酸銅,二辛可寧酸鹽較佳者係二辛可寧酸 鈉,而避免銅離子與二辛可寧酸鹽產生沉澱物之化合物或 其衍生物係;f爭檬酸鹽,較佳者係檸檬酸鈉。 檢驗試片中所用載體係由吸附液體之物質所構成,較佳 者係濾紙、硝化纖維膜、耐龍膜及玻璃纖維,最佳者係濾 紙。 本發明另係關於一種用於檢測檢體中尿酸之組件,包括 本發曰月之檢驗試片。其可i 升女另包括一對照檢驗結果之 色卡。 7 515886 A7 B7 五、發明説明(5 ) 本發明之檢驗試片或組件可適用之檢體包括但不限於全 血、血清、唾液或尿液。其中如檢體為唾液或尿液’則一 般消費者可於居家*中進行檢測。 由於檢體中尿酸濃度之多寡會影響試劍反應顏色由近乎 白色至深紫色等顏色變化,因此檢驗結果可利用對照色卡 便利比對,以利居家中或無比色計情形下進行尿酸之定性 與定量分析。 本發明另係關於一種用於檢測檢體中尿酸之方法,包括 下列步驟: (a) 以本發明之去干擾膜遮蔽檢體中尿酸之干擾物, (b) 用檢測尿酸之試劑與步驟⑻遮蔽干擾物之檢體反應, 及 ㈡觀察試劑之丨顏色變化。 本發明之方法‘中,步驟⑸中所用試劑係含銅離子、二辛 可寧酸鹽及視需要避免銅離子與二辛可寧酸鹽產生沉澱物 之化合物或其衍生物之混合溶液,其中銅離子係來自能提 供銅離子之化合物或其衍生物,較佳者係硫酸銅,二辛可 甲故鹽較佳者係二辛可寧酸鋼,而避免銅離子與二辛可寧 故鹽產生沉;殿物之化合物或其衍生物係檸檬酸鹽,較佳者 係檸檬酸鈉。於製備混合溶液時,銅離予與避免產生沉廄 物足化合物先混合,然後再加二辛可寧酸鹽之溶液,形成 一混合溶液。 若體中有尿酸存在,則試劑之顏色變化由近乎白色至 深紫色。 本纸張尺度適用中國國家標準(CNS ) Λ4規格(210X297公釐) (請先閎讀背面之注意事項再 衣-- 本頁j 、可 經濟部智慧財產局員工消費合作社印製 515886 A7 B7 五、發明説明(6 經濟部智慧財產局Μ工消赍合作社印製 本發明义万法可適 , p 、 避用足松眼包括但不限於全血、血攻 唾液或尿液。尤A 血α、 ,、疋核肢右係唾液或尿液可便利於居家+ 進行檢測。— 你豕中 本發明之方'、、i* /中,檢測結果可於醫院或檢驗所 計定量尿酸,今刊田,从+ I 用比色 哀利用組件中對照色卡便利比對,以利 中或無比色計情开彡下、#厂p A、 豕 、3形下進仃尿鉍又定性與定量分析。是以, 本各明之万去中’ g包括將檢測結果對照該試劑於不同尿 酸濃度下所呈現已知顏色變化之步驟。 為了使2發明的目的、方&、特徵及原理更清楚_ > 炫以下列S例配合附圖作詳細敘述,但此等實例並不對本 發明範圍作任何侷限。 ^ 實例 一....片的製備 取一片具有黏性之背板,製作直徑0·5公分之圓形孔洞, 即為撐體層。先製備含0.08%(w/v) Cu2+與0 · 0 2 Μ檸檬酸制之 洛液’充份攪拌混合後,再加入1.28%(w/v)BCA,形成一混 合溶液,將濾紙(S&S 2043b)浸於泡該混合溶液,烘乾,裁剪 成0.8 X 0.8公分之紙片,即為試劑反應層。將不織布浸泡在 含2g/dl半胱胺酸的NaHyPO4溶液後,烘乾,裁剪成〇·8χι.〇公 分之大小’即為去干擾膜。將試劑反應層黏附於撐體層之圓 形孔洞上,再將去干擾膜黏附於試劑反應層,以護貝機將 整個結構壓緊,形成檢驗試片。 實例二:尿酸檢驗試片及組件之使用方法 取檢體25微升滿於尿酸檢驗試片上’作用一十秒後,若 -9 本纸張尺度適用中國國家標準(CNS ) Λ4規格(210Χ297公釐) (請先聞讀背面之注意事項再本頁)Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, 1T 515886 A7 B7 V. Description of the invention (4) 2f Read the “___ items on the back, then this page and glass fiber, the best is non-woven fabric. The color of the carrier is not particularly limited but is mainly a color that does not affect the reaction of the reagent, preferably light or white, and most preferably white. -The present invention also relates to a test strip for detecting uric acid in a specimen, which includes a reagent reaction layer including a reagent and a carrier, wherein the reagent system contains steel ion (Cu2 +), bicinchoninic acid (bicinch). ninate, BCA) and compounds or derivatives thereof that avoid the precipitation of copper ions and dioctanoic acid. The test strip of the present invention optionally includes a de-interference film, which is located above the reagent reaction layer, and includes a compound or a derivative thereof that shields the uric acid detection interfering substance, and a carrier having permeability of the specimen. The test strip of the present invention optionally includes a support layer or a backing plate, which is positioned below the reagent reaction layer and opens a hole at a corresponding position of the test specimen as needed. The support layer is made of a material that supports the reagent reaction layer and the anti-interference film, and is preferably a plastic material. The copper ion in the printed reagent of the cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs is derived from a compound or a derivative thereof capable of providing copper ion. The preferred one is copper sulfate, and the better one is dioctanoic acid. Sodium, while avoiding copper ions and dioctanoic acid salt to produce a compound or derivative thereof; f citrate, preferably sodium citrate. The carrier used in the test specimen is composed of a substance that adsorbs liquid, preferably a filter paper, a nitrocellulose membrane, a dragon-resistant membrane, and glass fiber, and the best is a filter paper. The present invention also relates to a component for detecting uric acid in a specimen, including a test strip of the present invention. It can also include a color chart of the control test results. 7 515886 A7 B7 V. Description of the invention (5) The applicable specimens of the test strips or components of the present invention include, but are not limited to, whole blood, serum, saliva or urine. Among them, if the specimen is saliva or urine ', the consumer can usually perform the test at home *. Since the concentration of uric acid in the specimen will affect the color change of the test sword reaction color from nearly white to dark purple, the test results can be easily compared using a control color card to facilitate the qualitative analysis of uric acid at home or without a colorimeter. And quantitative analysis. The present invention also relates to a method for detecting uric acid in a specimen, including the following steps: (a) shielding the uric acid interfering substance in the specimen with the interference removing film of the present invention, (b) reagents and steps for detecting uric acid; Mask the reaction of the interferent and observe the color change of the reagent. In the method of the present invention, the reagent used in step (i) is a mixed solution containing copper ions, dioctanoic acid, and a compound or a derivative thereof that avoids precipitation of copper ions and diocinic acid, if necessary, wherein The copper ion is derived from a compound or a derivative thereof capable of providing copper ions, preferably copper sulfate, and diocinic acid sodium salt, and more preferably diocinic acid steel, while avoiding copper ion and dicinnine salt The compound or derivative thereof that produces a sink is citrate, preferably sodium citrate. In the preparation of the mixed solution, the copper ion is mixed with the compound that avoids the formation of sediments, and then a solution of diocinonate is added to form a mixed solution. If uric acid is present in the body, the color of the reagent changes from almost white to dark purple. This paper size applies the Chinese National Standard (CNS) Λ4 specification (210X297 mm) (Please read the precautions on the back before printing-this page j, printed by the Intellectual Property Bureau Staff Consumer Cooperative of the Ministry of Economic Affairs 515886 A7 B7 5 2. Description of the invention (6) The printed method of the invention is applicable to the Intellectual Property Cooperative Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, p, avoiding foot loose eyes include but are not limited to whole blood, blood attack saliva or urine. Especially A blood α The saliva or urine of the right limb of the nucleus limb can be easily tested at home +. — You can learn the formula of the present invention ',, i * /, the test results can be quantitatively measured in the hospital or laboratory, uric acid, this issue Tian, use the colorimeter to compare the color card with the colorimetric module to facilitate the comparison, in order to facilitate the use of colorimetric or non-colorimetric calculations, such as diarrhea, #plant p A, diarrhea, and urinary bismuth in the shape of 3, and qualitative and quantitative analysis. Therefore, Ben Gengming's "g" includes the step of comparing the test result with a known color change of the reagent at different uric acid concentrations. In order to make the purpose, formula & characteristics and principles of 2 inventions clearer_ > The following S examples are described in detail with the accompanying drawings, but these The examples do not place any limitation on the scope of the present invention. ^ Example 1 ... Preparation of a sheet A viscous back plate is made to make a circular hole with a diameter of 0.5 cm, which is the support layer. First, it contains 0.08% (w / v) Cu2 + is mixed with 0. 0 2 M citric acid solution. After mixing, add 1.28% (w / v) BCA to form a mixed solution. Dip filter paper (S & S 2043b) After soaking the mixed solution, drying and cutting into 0.8 X 0.8 cm pieces of paper, which is the reagent reaction layer. The non-woven cloth was soaked in NaHyPO4 solution containing 2g / dl cysteine, dried, and cut into 0.8 × x. The size of 0 cm is the interference removing film. The reagent reaction layer is adhered to the circular holes of the support layer, and then the interference interference film is adhered to the reagent reaction layer, and the entire structure is compacted with a shell guard to form an inspection test piece. Example 2: How to use uric acid test strips and components 25 microliters of specimens are filled on the uric acid test strips. After ten seconds of action, if -9 this paper size applies the Chinese National Standard (CNS) Λ4 specification (210 × 297 (Mm) (Please read the notes on the back first, then this page)

、τ Γ, Τ Γ

I 515886 A7 B7 經濟部智慈財產局員工消费合作社印製 五、發明説明(7 ) 檢體中有尿酸存在則呈現深紫色至淺紫色之顏色變化。檢 測結果以組件中試劑反應結果之對照色卡比對,或以比色 儀(Nippon,NR-3000)-記錄波長557nm之反射值。 實例三:有無去干擾膜對尿酸檢驗之影響 依實例一之方法將試劑反應層黏附於撐體層之圓形孔洞 上,以護貝機將整個結構壓緊,形成無去干擾膜之檢驗試 片。 依實例二之比色儀方法,用如下不同檢體(a)-(c)評估有無 去干擾膜對尿酸檢驗之影響: 檢體⑷分別僅含尿酸、抗壞血酸與半胱胺酸; 檢體(b)含尿酸與0,2及10mg/dl抗壞血酸; 檢體(c)含尿酸與0,15及150mg/dl半胱胺酸。 由於顏色愈深者,反射值(Y值)反而愈小。是以,從圖 3 (A)-3(C)中可知於無去干擾膜時抗壞血酸及/或半胱胺酸之 反射值低於尿酸之反射值,尤其圖3 (A)中顯示抗壞血酸較尿 酸先呈色,因而無去干擾膜之檢驗試片無法專一性檢測尿 酸。反之,從圖4 (A)-4(C)中可知於含去干擾膜時抗壞血酸 及半胱胺酸對尿酸檢測並無實質影響,尤其圖4(A)中顯示尿酸 較抗壞血酸與半胱胺酸強,證實含去干擾膜之檢驗試片能專 一性檢測尿酸。 實例四:酵素法與本發明方法之比較 依已知方法(如Du Pont/Dimension )進行酵素法以定量尿 酸。 依實例二之比色儀方法進行本發明方法。 -10 - (請先閱讀背面之注意事項再本頁) I'衣· 太 訂 本紙張尺度適用中國國家標準(CNS ) Λ4規格(210X 297公釐) 515886 Μ ______________Β7 五、發明説明(8 ) j圖5" 員示酵素法與本發明方法之相闕係數為_ 證實本發明万法亦可與酵素法同樣專—性檢測尿酸。 本發明可容許各-種修改及變化形式,本案已藉實例之方 式例示並詳細說明特定具體實施例。然而,應了解該等實 例並非用以限制本發明,而本案涵蓋所附申請專利範圍所 疋義之本發明之精神及範圍内之所有之修飾、類似及改 變 〇 經濟部智慧財產局員工消赀合作社印製 適 度 尺 張 纸 本 準 一標 I家 國 祕 1釐 公I 515886 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Office of the Ministry of Economic Affairs. 5. Description of the invention (7) The presence of uric acid in the specimen changes from dark purple to light purple. The detection result is compared with the control color card of the reagent reaction result in the module, or the colorimeter (Nippon, NR-3000) -recorded reflection value at the wavelength of 557nm. Example 3: The effect of the presence or absence of the interference-free film on the uric acid test. According to the method of Example 1, the reagent reaction layer was adhered to the circular holes of the support layer. . According to the colorimeter method of Example 2, use the following different specimens (a)-(c) to evaluate the effect of the presence or absence of the interference film on the uric acid test: The specimen ⑷ contains only uric acid, ascorbic acid and cysteine, respectively; b) containing uric acid and 0, 2 and 10 mg / dl ascorbic acid; specimen (c) containing uric acid and 0, 15 and 150 mg / dl cysteine. The darker the color, the smaller the Y value. Therefore, it can be seen from Fig. 3 (A) -3 (C) that the reflection value of ascorbic acid and / or cysteine is lower than the reflection value of uric acid in the absence of a de-interference film. In particular, Fig. 3 (A) shows that ascorbic acid Uric acid first develops color, so the test strip without interference film cannot specifically detect uric acid. Conversely, from Figures 4 (A) -4 (C), it can be seen that ascorbic acid and cysteine have no substantial effect on the detection of uric acid when the interference film is removed. In particular, Figure 4 (A) shows that uric acid is better than ascorbic acid and cysteamine. Strong acidity, confirming that the test strips with interference-free film can specifically detect uric acid. Example 4: Comparison of the enzyme method and the method of the present invention The enzyme method was performed according to a known method (such as Du Pont / Dimension) to quantify uric acid. The method of the present invention was performed according to the colorimeter method of Example 2. -10-(Please read the precautions on the back first, then this page) I'm too large. The paper size is applicable to the Chinese National Standard (CNS) Λ4 specification (210X 297 mm) 515886 ______________B7 V. Description of the invention (8) j Fig. 5 shows that the correlation coefficient between the enzyme method and the method of the present invention is _, which confirms that the method of the present invention can also be as specific as the enzyme method for detecting uric acid. The present invention is susceptible to various modifications and variations. The present application has been exemplified and described in detail by way of examples. However, it should be understood that these examples are not intended to limit the present invention, and this case covers all modifications, similarities and changes within the spirit and scope of the present invention as defined by the scope of the attached patent application. Printed a moderate ruled paper, one standard, 1 centimeter of the National Secret

Claims (1)

515886 第881〇7229號專利申請案 AS 中文申請專利範圍修正本(9〇年6月)$ 申請專利範匡515886 Patent Application No. 881〇7229 AS Chinese Patent Application Amendment (June 90) $ Application for Patent '.............. |丨 _ _ 1· 一種用於檢測檢體中尿酸之去干擾膜,包括遮蔽尿酸檢 煩 請 委 員 明 示 本 案 修 正 後 是 否 變 更 原 實 質 容 經 郅 中 央 標 準 員 工 消 費 合 作 社 印 製 測干擾物之化合物或其衍生物,及具有可吸收大量遮蔽 干擾物之化合物、檢體吸收及通透性強、檢體流通後即 可迅速釋出遮蔽干擾物之化合物、且不會與遮蔽干擾物 之化合物起化學變化之載體,其中該遮蔽尿酸檢測干擾 物 < 化合物係具高溶解度且含銃基之胺基酸或其聚合 物。 2·根據申請專利範圍第丨項之去干擾膜,其中該化合物係 半胱胺酸或穀胱甘肽。 3·根據申請專利範圍第2項之去干擾膜,其中該化合物係 半胱胺酸。 4·根據申叫專利範圍第丨項之去干擾膜,其中載體係不織 布、濾紙、硝化纖維膜、耐龍膜及玻璃纖維。 5·根據申請專利範圍第4項之去干擾膜,其中載體係不織< 布〇 6·根據申請專利範圍第i項之去干擾膜,其中載體呈淺色 或白色。 7.根據申請專利範圍第6項之去干擾膜,,其中載體呈白 色。 8· —種用於檢測檢體中尿酸之檢驗試片,其中包含一試劑 反應層,其包括試劑與載體,其中該試劑係含銅離子 (Cu2+)、二辛可寧酸鹽(bicinch〇ninate,BCA)及避免銅離子 與二辛可寧酸鹽產生沉澱物之酸性螯合物或其衍生物, 其中另包括根據申請專利範圍第丨至7項中任一項之去干 CNS)職 (請先閲讀背面之注意事項再填寫本頁)'.............. | 丨 _ _ 1 · A kind of anti-interference film for detecting uric acid in a specimen, including masking uric acid郅 Central standard employee consumer cooperatives print compounds or derivatives of interferences, and compounds that can absorb large amounts of shielding interferences. Specimens have strong absorption and permeability, and can quickly release shielding interferences after the circulation of specimens. A compound that does not chemically change with the compound that masks the interfering substance, wherein the masking uric acid detecting interfering substance < compound is an amino acid having a high solubility and containing a fluorenyl group or a polymer thereof. 2. The interference removing membrane according to item 丨 of the patent application scope, wherein the compound is cysteine or glutathione. 3. The interference removing membrane according to item 2 of the scope of patent application, wherein the compound is cysteine. 4. According to the patent claim No. 丨, the interference-free membrane, in which the carrier is non-woven fabric, filter paper, nitrocellulose membrane, dragon-resistant membrane and glass fiber. 5. The interference removing film according to item 4 of the scope of the patent application, wherein the carrier is non-woven < cloth. 6. The interference removing film according to item i of the scope of the patent application, wherein the carrier is light or white. 7. The interference removing film according to item 6 of the patent application scope, wherein the carrier is white. 8 · —A test strip for detecting uric acid in a specimen, which includes a reagent reaction layer including a reagent and a carrier, wherein the reagent contains copper ion (Cu2 +), bicinchoninate , BCA) and acidic chelates or derivatives thereof that avoid the precipitation of copper ions and dioctnonic acid salts, which also includes the desiccation of CNS according to any one of the scope of patent applications No. 丨 7) ( (Please read the notes on the back before filling out this page) 515886515886 、申請專利範圍 經濟部中央榡準局員工消費合作衽印製 擾膜’其位於試劑反應層上方、。 9·根據申請專利範圍第8項之檢驗戟片,另包括撑體層, 其位於試劑反應層下方且视需要於檢測檢體對應位置上 開一孔洞。· 10.根據申請專利範圍第9項之檢驗試片,其中樓體層為膠材質。 '曰為 u·㈣申請專利範圍第8項之檢驗試片,其中鋼離子係 自硫酸銅。 12.根據申請專利範圍第8項之檢驗試片,.其中二辛可寧 现係一辛可寧酸納。 13·=據申請專利範圍第8項之檢驗試片,其中避免銅㈣ 人-辛可寧酸鹽產生沉澱物之化合物係擰檬酸納。 ^據中請專利範圍第8項之檢驗試片,其中㈣㈣ 15·根據申請專利範圍第9項之檢驗試片,其中去干擾膜中 返蔽干擾尿酸檢測之化合物係半胱胺酸。 16·根據申請專利範圍第8項之檢驗 ,,. 片,其中檢體係全 血、血清、唾液或尿液。、、 17·根據申請專利範圍第17項之檢驗試片 或尿液。 其中檢體係 18·根據申請專利範圍第18項之檢驗試片,1 pr ^ , ’其中該檢測 居家中進行。 19· 一種用於檢測檢體中尿酸之套組,包技 根據申請專利範圍第8至18項中任一巧之檢驗、戈片 唾 可 塑 來 酸 (請先閲讀背面之注意事項再填寫本頁)Scope of patent application: Consumption cooperation with employees of the Central Bureau of Standards, Ministry of Economic Affairs, and printed interference film, which is located above the reagent reaction layer. 9. The inspection halberd sheet according to item 8 of the patent application scope, further including a support layer, which is located under the reagent reaction layer and opens a hole in the corresponding position of the test specimen as needed. · 10. The test piece according to item 9 of the scope of patent application, in which the floor is made of glue. 'It is the test piece of item No. 8 of the scope of U.S. patent application, in which the steel ion is from copper sulfate. 12. According to the test strip of item 8 of the scope of the patent application, the dicinnine is now a monocinnine. 13 · = The test strip according to item 8 of the scope of the patent application, in which the compound that avoids the precipitation of copper ㈣ human-cinnamic acid salt is sodium citrate. ^ According to the request, the test strip of the patent scope item 8 includes ㈣㈣ 15. According to the test scope of the patent application scope item 9, the test strip is a cysteine, which is a compound that interferes with the detection of uric acid in the interference film. 16. According to the test of the scope of the patent application No. 8 test, ..., the whole blood, serum, saliva or urine. 17, 17. Test specimens or urine according to item 17 of the scope of patent application. Among them, the inspection system 18. According to the test strip of the 18th scope of the patent application, 1 pr ^, ′ where the inspection is performed at home. 19 · A kit for detecting uric acid in a specimen, including a test according to any one of the patent application scope Nos. 8 to 18, and a tablet of sialic acid (please read the precautions on the back before filling this page) ) 訂 > ϋ·^— 111 · 紙張^適用中國囷家標準(CNS广八4麟(2ι〇χ297公董) 515886 經濟部中央標準局員工消費合作社印製 A8 B8 C8 ^———^^ 穴、申請專利範圍 ~--— 2〇.根據申請專利範圍第20項之套'组,其另包括檢驗結果之 對照色卡。 21.根據申請專利範圍第2〇項之套组,其中對照色卡列有不 同尿酸濃度與試劑反應之已知顏色變化。 22·根據申凊專利範圍第19項之套組,其中顏色變化係由近 乎白色至深紫色。 23.根據申請專利範圍第19項之套組,其中檢體係全血、血 清、唾液或尿液。 24·根據申請專利範圍第23項之套組,其中檢體係唾液或尿 液。 25.根據申請專利範圍第24項之套組,其中檢測係於居家中 進行。 26· —種檢測檢體中尿酸之方法,包括下列步驟: ⑻以根據申請專利範圍第1至7項中任一項之去干擾膜 遮蔽檢.體冲檢測尿酸之干擾物; ⑸用檢測尿酸之試劑與步驟⑻遮蔽干擾物之檢體反 應,其中梦試劑係銅離子(Cu2+)、二辛可寧酸鹽 (bicinchoninate,BCA)及避免銅離子與二辛可寧酸鹽產 生沉澱物之酸性螯物或其衍生物;及 (c)觀祭试劑之顏色變化。 27. 根據申請專利範圍第26項之方法,其中試劑中銅離子與 避免產生沉澱物之化合物必須先混合,然後再加二辛可 寧酸鹽之溶劑。 28. 根據申請專利範圍第26項之方法,其中避免產生沉澱物 "" ........ 丨 111 — ^ — 本紙張纽適用中國®家標準(CNS)A4_( 210X297>i^ ) '---—- (請先閱讀背面之注意事項再填寫本頁)Order > ϋ · ^ — 111 · Paper ^ Applicable to Chinese family standards (CNS Guangba 4 Lin (2ιχχ297)) 515886 Printed by A8 B8 C8 of the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs ^ ———— ^^ 2. The scope of patent application ~ --- 20. According to the set of patent application scope No. 20, it also includes the control color card of the test results. 21. According to the patent application scope No. 20 of the suite, the reference color The card lists the known color changes of different uric acid concentrations and reagent reactions. 22. According to the 19th set of the patent application, the color change is from nearly white to dark purple. 23. According to the 19th application patent scope Sets, in which whole blood, serum, saliva or urine are tested. 24. Sets according to item 23 of the scope of patent application, in which saliva or urine is tested. 25. Sets according to item 24 of the patent scope, The detection is carried out at home. 26 · —A method for detecting uric acid in a specimen, including the following steps: ⑻A masking test to remove the interference film according to any one of claims 1 to 7 of the scope of patent application. Interference The reagent of uric acid reacts with the sample of step ⑻ shielding interferences, among which the dream reagent is copper ion (Cu2 +), bicinchoninate (BCA) and avoids the precipitation of copper ion and dioctyl cotinate Acid chelates or their derivatives; and (c) the color change of the spectacle reagents. 27. The method according to item 26 of the scope of the patent application, wherein the copper ions in the reagents and the compounds to avoid precipitation must be mixed before Add the solvent of dioctanoic acid. 28. According to the method in the scope of patent application No. 26, which avoids the precipitation " " ........ 丨 111 — ^ — This paper is suitable for China® Home Standard (CNS) A4_ (210X297 > i ^) '----- (Please read the precautions on the back before filling this page) Order 經濟部中央標準局員工消費合作社印製 、申請專概j 之化合物係擰檬酸#5。 ::請㈣圍第26項之方法,其中步驟㈡中試劑之 》 万、尿酸存在下呈由近乎白色至深紫色。 30=據申請專利範圍第29項之方法,其中檢體係全血、血 岣、唾液或尿液。 31·根據中請專利範圍第26項之方法,纟中檢體係唾液或尿 液。 32·根據申請專利範圍第31項之方法,其中檢測係於居家中 進行。 33·根據申請專利範圍第26至32項中任一項之方法,其另包 括比色分析之步驟以定量檢體中尿酸之含量。 34·根據申請專利範圍第33項之方法,其中比色分析之步驟 係以比色計檢測。 35·根據申請專利範圍第33項之方法,其中比色分析之步驟 係以步驟(c)觀察試劑之顏色變化對照該試劑於不同尿酸 濃度下所呈之已知顏色變化。 表紙張尺度適用中國國家梂準(CNS ) Α4規格(210X297公釐) (請先閱讀背面之注意事項再填寫本頁)The compound printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs and applying for a summary is citric acid # 5. :: Please enclose the method of item 26, in which the reagent in step ㈡ 10,000, in the presence of uric acid, from almost white to dark purple. 30 = The method according to item 29 of the scope of patent application, in which whole blood, blood diarrhea, saliva or urine are detected. 31. According to the method in the patent application No. 26, saliva or urine of the inspection system. 32. The method according to item 31 of the scope of patent application, wherein the detection is performed at home. 33. The method according to any one of claims 26 to 32 of the scope of patent application, which further comprises a step of colorimetric analysis to quantify the content of uric acid in the specimen. 34. The method according to item 33 of the scope of patent application, wherein the step of colorimetric analysis is detected with a colorimeter. 35. The method according to item 33 of the scope of patent application, wherein the step of colorimetric analysis is to observe the color change of the reagent in step (c) and compare the known color change of the reagent at different uric acid concentrations. The paper size of the table is applicable to China National Standard (CNS) Α4 specification (210X297 mm) (Please read the precautions on the back before filling this page)
TW88107229A 1999-05-04 1999-05-04 Eliminating interference membranes containing compound having mercapto, and test strips, kits and methods for use in uric acid assay TW515886B (en)

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