M303000 八、新型說明： 【新型所屬之技術領域】 本創作係提出一種檢測構件及其包覆殼體，特別是關 - 於藉由該包覆殼體係為一不易反光之材質以確保光學檢測 設備檢測之準確性。 ' 【先前技術】 修 體外臨床诊斷已為醫療器材產業中相當重要的一環， 由於體外臨床診斷必須要在醫院中央化驗室進行，對某些 疾病的診斷造成不便與效率的降低，嚴重起來甚至於影響 生命安全，因此帶動了國際間大小廠商競相針對所謂醫護 地點檢測（POCT，point-of-care testing)技術進行發展。 因為所謂醫護地點檢測基本需求，就是經濟、快速與簡便。 目前，醫護地點檢測較為常見的手段即為利用量測反射係 數變化原理之定量P0CT裝置，可專門為急性心肌梗塞、腎 • 衰竭、血紅素HbAlc、糖尿病或是攝護腺癌篩檢等等疾病 進行其體外臨床檢測。 量測反射係數的P0CT裝置，其搭配使用之檢測試紙具 ' 有包覆於外侧之試紙盒，可方便使用者採集生物檢體及提 供P0CT裝置讀取。檢測試紙中塗佈有酵素或其他化學反應 材料，用於與採集之生物檢體發生反應，並依據不同的反 應結果而反射P0CT裝置不同種類或強弱之光波，其可供 P0CT裝置讀取並加以分析，藉此根據反射之光波種類及強 M303000 弱以產生檢測結果。 但疋’對於濃度較低或反應後產生之光波較微弱的一 些疾病標誌物，例如游離前列腺癌特殊抗原（f reePSA)及一 些固醇激素，POCT裝置於讀取分析時容易因受到干擾而降 低檢測之專確性，尤其是包覆於試紙本體外側之試紙盒常 會有反光現象，其為干擾POCT裝置之主要因素。 有鑑於此，若欲確保檢測結果之準確性，減少裝置檢 測時之干擾因素為當務之急，因此，本創作人經多方研究 # 設計與專題楝討，遂於本創作提出一種檢測構件及其包覆 殼體以作為上述期望之實現方式與依據。 【新变内容】 有鑑於上述課題，本創作之目的為提供一種檢測構件 及其包覆殼體，特別是關於藉由包覆殼體具有不易反光材 質，以避免產生干擾檢測裝置之反射光，確保檢測之準確 性。 籲 緣是，為達上述目的，依本創作之檢測構件，其包含 有〆檢測主體及一包覆殼體，可提供光學檢測裝置進行檢 測以彥生一檢測資訊，包覆殼體用於包覆檢測主體，藉此 方便操作端利用檢測構件採集待測標本並將檢測構件置入 光攀檢測裝置以對檢測主體或採集之待測標本進行檢測。 包覆彀體具有不易反光材質，例如黑色或深色材質，藉此 町避免影響光學檢測裝置之檢測，增加光學檢測裝置所產 山厶檢測資訊的準確性。 M303000 承上所述，因依本創作之檢測構件通常為用於採集如 血液之待測標本的檢測試紙’其可置入光學檢測裝置中以 供檢測。檢測主體為一試紙本體，包含有一採集區及一讀 取區，採集區用於採集上述之待測標本，試紙本體塗佈有 酵素或其他化學反應材料，其用以與待測標本發生反應， 藉此可反射光學檢測裝置之光波，讀取區則為提供光學檢 測裝置檢測反射之光波的位置，包覆殼體具有分別對應採 集區及讀取區之開口或透光區域，其中，對應讀取區之開 口或透光區域的周圍尤其需使用不易反光材質，以達成本 創作之目的。 茲為使貴審查委員對本創作之技術特徵及所達成之 功效有更進一步之暸解與認識，下文謹提供較佳之實施例 及相關圖式以為輔佐之用，並以詳細之說明文字配合說明 如後。 【實施方式】 為讓本創作之上述目的、特徵、和優點能更明顯易懂， 下文依本創作揭露之檢測構件及其包覆殼體，特舉較佳實 施例並配合所附相關圖式，作詳細說明如下，其中相同的 元件將以相同的元件符號加以說明。 請參閱第一圖及第二圖，第一圖係為本創作所揭露之 檢測構件之包覆殼體之示意圖，第二圖係為本創作所揭露 檢測構件之包覆殼體置入檢測裝置之示意圖。如第一圖所 示，包覆殼體12具有第一開口 121、第二開口 122及固持 M3 03 000 端124，包覆殼體I?自 開口⑽第二開口〗自二之反光材質123製作，第- 相關，且，如第二田私_汗叹位置與所包覆之檢測主體 入或抽取包覆殼體12，；二=124可供操作者方便置 21中，使檢測震置21 覆殼體12置入檢測裝置 12所包覆的檢測主可:二乐二開口 122以對包覆殼體 紙本體，包覆殼體12 上敎㈣主體通常為試 各，咨迚不尽κ 2較仫為不易反光之黑色或深色試紙 ^域不易反光材質123亦可局部形成於第二開口 122 實施=!二其=創作所揭露之― 11及包覆殼體12'圖件1包含有檢測主體 儲存區Η3、第「中=測主體11具有採集區111、 114,包覆殼體12:==二讀取區1122及蝴 的第-開口 121;:不庫易第反先材/123及_^^^ 1122的第二開口⑵對應弟;^取區1121與第二讀取區 加入至採集區u 2且口 121以將待测標本 第-讀取區1121及第本具有抗原或是核酸片段。 體。另外，健六弟—頊取區丨丨22上具有不同之第一抗 結合物邻位。1=、113上設有相_素與第二抗體之共輪 ° §待測標本加入採集區m後，待測標本中 的抗原或減片段首先錢存區113與麟素與第二抗體 ，共祕合物部位進行制，遂再經毛細現象移動到 弟-讀取區1121及第二讀取區1122與其卜抗體進行作 用。當此反應達到平衡後，未反應的酵素與第二抗體之此 軛結合物部位則會移動到吸水墊114上'。藉由上述，檢測 M303000 裝置21可透過第二開口 122以提供一光波至第一讀取區 1121及第二讀取區1122，第一讀取區1121及第二讀取區 1122儲存之反應結果再透過第二開口 122以反射光波予此 檢測裝置21，檢測裝置21即可感測此反射光波以進一步 取得檢測資訊。上述之待測標本為血液或其他生物檢體， 檢測構件1為一種檢測試紙。藉由包覆殼體12具有不易反 光材質123,即可避免干擾檢測裝置21感測第一讀取區 1121及第二讀取區1122反射之光波，達到本窗創作之目 的。 以上所述僅為舉例性，而非為限制性者。任何未脫離 本創作之精神與範疇，而對其進行之等效修改或變更，均 應包含於後附之申請專利範圍中。 【圖式簡單說明】 第一圖係為本創作所揭露之檢測構件之包覆殼體之示 意圖； 第二圖係為本創作所揭露檢測構件之包覆殼體置入檢 測裝置之示意圖；以及 第三圖係為本創作所揭露之檢測構件之較佳實施例之 不意圖。 M303000 【主要元件符號說明】 I ·檢測構件， II :檢測主體； III :採集區； 1121 :第一讀取區； 1122 :第二讀取區； 113 :儲存區； 114 :吸水墊； 12 :包覆殼體； 121 :第一開口； 122 :第二開口； 123:不易反光材質； 124 :固持端；以及 21 :檢測裝置。M303000 VIII. New description: [New technical field] The present invention proposes a detecting member and a covering casing thereof, in particular, the optical housing is ensured by the covering casing as a material that is not easily reflective. The accuracy of the test. [Prior Art] In vitro clinical diagnosis has become a very important part of the medical equipment industry. Because in vitro clinical diagnosis must be carried out in the central laboratory of the hospital, the diagnosis of certain diseases is inconvenient and the efficiency is reduced, even worse. Affecting life safety, it has led international and large-scale manufacturers to compete for the development of so-called point-of-care testing (POCT). Because the so-called medical site detection basic needs, it is economic, fast and simple. At present, the more common means of detecting medical sites is the quantitative P0CT device that uses the principle of measuring the change of reflectance. It can be used for acute myocardial infarction, kidney failure, hemoglobin HbAlc, diabetes or prostate cancer screening. Perform in vitro clinical testing. The P0CT device for measuring the reflection coefficient, which is used in conjunction with the test strip, has a test tray wrapped around the outside, which is convenient for the user to collect the biopsy and provide the P0CT device for reading. The test strip is coated with an enzyme or other chemical reaction material for reacting with the collected biological sample, and reflecting different types or strong and weak light waves of the P0CT device according to different reaction results, which can be read and applied by the P0CT device. Analysis, according to the type of light wave reflected and the weak M303000 to produce test results. However, for some disease markers with low concentration or weak light waves after the reaction, such as free prostate cancer specific antigen (f reePSA) and some sterols, the POCT device is easily reduced by interference during reading analysis. The accuracy of the test, especially the test paper wrapped on the outside of the test paper body, often has a reflection phenomenon, which is the main factor that interferes with the POCT device. In view of this, if you want to ensure the accuracy of the test results and reduce the interference factors in the device detection, it is a matter of urgency. Therefore, the creator has made a multi-party study # design and topic discussion, and proposed a test component and its cladding. The housing is used as a desired implementation and basis. [New content] In view of the above problems, the purpose of the present invention is to provide a detecting member and a covering casing thereof, in particular, to have a non-reflective material by covering the casing to avoid the reflection light of the interference detecting device. Ensure the accuracy of the test. In order to achieve the above objectives, the detecting member according to the present invention comprises a detecting body and a covering shell, and an optical detecting device is provided for detecting the information of the Yansheng test, and the covering shell is used for the package. The detecting body is covered, thereby facilitating the operation end to collect the specimen to be tested by using the detecting component and placing the detecting component into the light climbing detecting device to detect the detecting body or the collected specimen to be tested. The coated body has a non-reflective material, such as a black or dark material, so that the town avoids affecting the detection of the optical detecting device and increases the accuracy of the information detected by the optical detecting device. M303000 As described above, the detection member according to the present invention is usually a test strip for collecting a specimen to be tested, such as blood, which can be placed in an optical detecting device for detection. The detecting body is a test paper body, and comprises an collecting area and a reading area. The collecting area is used for collecting the above-mentioned sample to be tested, and the test paper body is coated with an enzyme or other chemical reaction material, which is used for reacting with the sample to be tested. Thereby, the light wave of the optical detecting device can be reflected, and the reading area is a position for providing the optical detecting device to detect the reflected light wave, and the covering shell has an opening or a light transmitting area corresponding to the collecting area and the reading area respectively, wherein the corresponding reading is performed. In particular, it is necessary to use a non-reflective material around the opening or the light-transmissive area to achieve the purpose of the creation. In order to provide a better understanding and understanding of the technical features and the efficacies achieved by the reviewers, the following examples are provided to facilitate the use of the preferred embodiments and related drawings, with detailed explanations and explanations. . [Embodiment] In order to make the above objects, features, and advantages of the present invention more comprehensible, the following describes a detecting member and a covering case thereof according to the present disclosure, and the preferred embodiment is combined with the related drawings. The detailed description is as follows, in which the same elements will be described with the same element symbols. Please refer to the first figure and the second figure. The first figure is a schematic view of the covering shell of the detecting component disclosed in the present invention, and the second figure is the covering shell insertion detecting device of the detecting component disclosed in the present invention. Schematic diagram. As shown in the first figure, the covering shell 12 has a first opening 121, a second opening 122 and a holding M3 03 000 end 124. The covering shell I is made from the second opening of the opening (10). , the first-related, and, for example, the second _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ The cover 12 is placed in the detection device covered by the detecting device 12: the Erle two opening 122 is used to cover the casing paper body, and the upper casing of the casing 12 is generally tested. 2 is more difficult to reflect black or dark test paper ^ domain is not easy to reflect material 123 can also be partially formed in the second opening 122 implementation =! 2 it = creation revealed - 11 and the cover shell 12 'Figure 1 contains There is detection main body storage area Η3, the first "middle = measuring main body 11 has collection areas 111, 114, covering the housing 12: == two reading areas 1122 and the first opening 121 of the butterfly; The second opening (2) of /123 and _^^^ 1122 corresponds to the younger; the accessing area 1121 and the second reading area are added to the collecting area u 2 and the port 121 to be the first reading area 1121 of the sample to be tested and The first one has an antigen or a nucleic acid fragment. In addition, the Jianliudi-顼取区丨丨22 has different first-anti-conjugates ortho-positions. 1=, 113 is provided with phase-prime and second antibody. A total of rounds § After the specimen to be tested is added to the collection area m, the antigen or subtraction fragment in the specimen to be tested is firstly deposited in the money storage area 113 with the nucleolin and the second antibody, and the cryptic part is moved to the capillary structure. The read-receiving region 1121 and the second read-in region 1122 act on their antibodies. When the reaction reaches equilibrium, the unconjugated enzyme and the conjugated site of the second antibody are moved to the absorbent pad 114'. By the above, the M303000 device 21 can pass through the second opening 122 to provide a light wave to the first read area 1121 and the second read area 1122, and the first read area 1121 and the second read area 1122 store the reaction result. Then, the second opening 122 is used to reflect the light wave to the detecting device 21, and the detecting device 21 can sense the reflected light wave to further obtain the detection information. The sample to be tested is blood or other biological sample, and the detecting member 1 is a detecting device. Test paper. By covering the casing 12 The non-reflective material 123 can prevent the interference detecting device 21 from sensing the light waves reflected by the first reading area 1121 and the second reading area 1122, thereby achieving the purpose of creating the window. The above description is merely exemplary, not Any equivalent modifications or changes made to the spirit and scope of this creation shall be included in the scope of the attached patent application. [Simplified illustration] The first picture is the creation A schematic view of the covered casing of the disclosed detecting member; the second drawing is a schematic view of the covering casing insertion detecting device of the detecting member disclosed in the present invention; and the third drawing is the detecting member disclosed in the present disclosure. The preferred embodiment is not intended. M303000 [Explanation of main component symbols] I · Detection component, II: detection body; III: acquisition area; 1121: first reading area; 1122: second reading area; 113: storage area; 114: absorbent pad; Covering the casing; 121: first opening; 122: second opening; 123: non-reflective material; 124: holding end; and 21: detecting device.